Comparison of the Working Alliance in Blended Cognitive Behavioral Therapy and Treatment as Usual for Depression in Europe: Secondary Data Analysis of the E-COMPARED Randomized Controlled Trial.

BACKGROUND: Increasing interest has centered on the psychotherapeutic working alliance as a means of understanding clinical change in digital mental health interventions in recent years. However, little is understood about how and to what extent a digital mental health program can have an impact on the working alliance and clinical outcomes in a blended (therapist plus digital program) cognitive behavioral therapy (bCBT) intervention for depression. OBJECTIVE: This study aimed to test the difference in working alliance scores between bCBT and treatment as usual (TAU), examine the association between working alliance and depression severity scores in both arms, and test for an interaction between system usability and working alliance with regard to the association between working alliance and depression scores in bCBT at 3-month assessments. METHODS: We conducted a secondary data analysis of the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment versus Treatment-as-usual) trial, which compared bCBT with TAU across 9 European countries. Data were collected in primary care and specialized services between April 2015 and December 2017. Eligible participants aged 18 years or older and diagnosed with major depressive disorder were randomized to either bCBT (n=476) or TAU (n=467). bCBT consisted of 6-20 sessions of bCBT (involving face-to-face sessions with a therapist and an internet-based program). TAU consisted of usual care for depression. The main outcomes were scores of the working alliance (Working Alliance Inventory-Short Revised-Client [WAI-SR-C]) and depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]) at 3 months after randomization. Other variables included system usability scores (System Usability Scale-Client [SUS-C]) at 3 months and baseline demographic information. Data from baseline and 3-month assessments were analyzed using linear regression models that adjusted for a set of baseline variables. RESULTS: Of the 945 included participants, 644 (68.2%) were female, and the mean age was 38.96 years (IQR 38). bCBT was associated with higher composite WAI-SR-C scores compared to TAU (B=5.67, 95% CI 4.48-6.86). There was an inverse association between WAI-SR-C and PHQ-9 in bCBT (B=-0.12, 95% CI -0.17 to -0.06) and TAU (B=-0.06, 95% CI -0.11 to -0.02), in which as WAI-SR-C scores increased, PHQ-9 scores decreased. Finally, there was a significant interaction between SUS-C and WAI-SR-C with regard to an inverse association between higher WAI-SR-C scores and lower PHQ-9 scores in bCBT (b=-0.030, 95% CI -0.05 to -0.01; P=.005). CONCLUSIONS: To our knowledge, this is the first study to show that bCBT may enhance the client working alliance when compared to evidence-based routine care for depression that services reported offering. The working alliance in bCBT was also associated with clinical improvements that appear to be enhanced by good program usability. Our findings add further weight to the view that the addition of internet-delivered CBT to face-to-face CBT may positively augment experiences of the working alliance. TRIAL REGISTRATION: ClinicalTrials.gov NCT02542891, https://clinicaltrials.gov/study/NCT02542891; German Clinical Trials Register DRKS00006866, https://drks.de/search/en/trial/DRKS00006866; Netherlands Trials Register NTR4962, https://www.onderzoekmetmensen.nl/en/trial/25452; ClinicalTrials.Gov NCT02389660, https://clinicaltrials.gov/study/NCT02389660; ClinicalTrials.gov NCT02361684, https://clinicaltrials.gov/study/NCT02361684; ClinicalTrials.gov NCT02449447, https://clinicaltrials.gov/study/NCT02449447; ClinicalTrials.gov NCT02410616, https://clinicaltrials.gov/study/NCT02410616; ISRCTN Registry ISRCTN12388725, https://www.isrctn.com/ISRCTN12388725?q=ISRCTN12388725&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10; ClinicalTrials.gov NCT02796573, https://classic.clinicaltrials.gov/ct2/show/NCT02796573. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-016-1511-1.

Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial.

BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary. OBJECTIVE: This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia. METHODS: A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit. RESULTS: In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it. CONCLUSIONS: The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04686-4.

The Clinical Effectiveness of Blended Cognitive Behavioral Therapy Compared With Face-to-Face Cognitive Behavioral Therapy for Adult Depression: Randomized Controlled Noninferiority Trial.

BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (FtF) consultations in a blended format may produce a new treatment format (B-CBT) with multiple benefits from both traditional CBT and iCBT, such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and possibly lower threshold to implementation. OBJECTIVE: The primary aim of this study is to compare directly the clinical effectiveness of B-CBT with FtF-CBT for adult major depressive disorder. METHODS: A 2-arm randomized controlled noninferiority trial compared B-CBT for adult depression with treatment as usual (TAU). The trial was researcher blinded (unblinded for participants and clinicians). B-CBT comprised 6 sessions of FtF-CBT alternated with 6-8 web-based CBT self-help modules. TAU comprised 12 sessions of FtF-CBT. All participants were aged 18 or older and met the diagnostic criteria for major depressive disorder and were recruited via a national iCBT clinic. The primary outcome was change in depression severity on the 9-item Patient Health Questionnaire (PHQ-9). Secondary analyses included client satisfaction (8-item Client Satisfaction Questionnaire [CSQ-8]), patient expectancy (Credibility and Expectancy Questionnaire [CEQ]), and working (Working Alliance Inventory [WAI] and Technical Alliance Inventory [TAI]). The primary outcome was analyzed by a mixed effects model including all available data from baseline, weekly measures, 3-, 6, and 12-month follow-up. RESULTS: A total of 76 individuals were randomized, with 38 allocated to each treatment group. Age ranged from 18 to 71 years (SD 13.96) with 56 (74%) females. Attrition rate was 20% (n=15), which was less in the FtF-CBT group (n=6, 16%) than in the B-CBT group (n=9, 24%). As many as 53 (70%) completed 9 or more sessions almost equally distributed between the groups (nFtF-CBT=27, 71%; nB-CBT=26, 68%). PHQ-9 reduced 11.38 points in the FtF-CBT group and 8.10 in the B-CBT group. At 6 months, the mean difference was a mere 0.17 points. The primary analyses confirmed large and significant within-group reductions in both groups (FtF-CBT: ß=-.03; standard error [SE] 0.00; P<.001 and B-CBT: ß=-.02; SE 0.00; P<.001). A small but significant interaction effect was observed between groups (ß=.01; SE 0.00; P=.03). Employment status influenced the outcome differently between groups, where the B-CBT group was seen to profit more from not being full-time employed than the FtF group. CONCLUSIONS: With large within-group effects in both treatment arms, the study demonstrated feasibility of B-CBT in Denmark. At 6 months' follow-up, there appeared to be no difference between the 2 treatment formats, with a small but nonsignificant difference at 12 months. The study seems to demonstrate that B-CBT is capable of producing treatment effects that are close to FtF-CBT and that completion rates and satisfaction rates were comparable between groups. However, the study was limited by small sample size and should be interpreted with caution. TRIAL REGISTRATION: ClinicalTrials.gov NCT02796573; https://clinicaltrials.gov/ct2/show/NCT02796573. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-016-1140-y.

Effect of Sleep Disturbance Symptoms on Treatment Outcome in Blended Cognitive Behavioral Therapy for Depression (E-COMPARED Study): Secondary Analysis.

BACKGROUND: Sleep disturbance symptoms are common in major depressive disorder (MDD) and have been found to hamper the treatment effect of conventional face-to-face psychological treatments such as cognitive behavioral therapy. To increase the dissemination of evidence-based treatment, blended cognitive behavioral therapy (bCBT) consisting of web-based and face-to-face treatment is on the rise for patients with MDD. To date, no study has examined whether sleep disturbance symptoms have an impact on bCBT treatment outcomes and whether it affects bCBT and treatment-as-usual (TAU) equally. OBJECTIVE: The objectives of this study are to investigate whether baseline sleep disturbance symptoms have an impact on treatment outcomes independent of treatment modality and whether sleep disturbance symptoms impact bCBT and TAU in routine care equally. METHODS: The study was based on data from the E-COMPARED (European Comparative Effectiveness Research on Blended Depression Treatment Versus Treatment-as-Usual) study, a 2-arm, multisite, parallel randomized controlled, noninferiority trial. A total of 943 outpatients with MDD were randomized to either bCBT (476/943, 50.5%) or TAU consisting of routine clinical MDD treatment (467/943, 49.5%). The primary outcome of this study was the change in depression symptom severity at the 12-month follow-up. The secondary outcomes were the change in depression symptom severity at the 3- and 6-month follow-up and MDD diagnoses at the 12-month follow-up, assessed using the Patient Health Questionnaire-9 and Mini-International Neuropsychiatric Interview, respectively. Mixed effects models were used to examine the association of sleep disturbance symptoms with treatment outcome and treatment modality over time. RESULTS: Of the 943 patients recruited for the study, 558 (59.2%) completed the 12-month follow-up assessment. In the total sample, baseline sleep disturbance symptoms did not significantly affect change in depressive symptom severity at the 12-month follow-up (ß=.16, 95% CI -0.04 to 0.36). However, baseline sleep disturbance symptoms were negatively associated with treatment outcome for bCBT (ß=.49, 95% CI 0.22-0.76) but not for TAU (ß=-.23, 95% CI -0.50 to 0.05) at the 12-month follow-up, even when adjusting for baseline depression symptom severity. The same result was seen for the effect of sleep disturbance symptoms on the presence of depression measured with Mini-International Neuropsychiatric Interview at the 12-month follow-up. However, for both treatment formats, baseline sleep disturbance symptoms were not associated with depression symptom severity at either the 3- (ß=.06, 95% CI -0.11 to 0.23) or 6-month (ß=.09, 95% CI -0.10 to 0.28) follow-up. CONCLUSIONS: Baseline sleep disturbance symptoms may have a negative impact on long-term treatment outcomes in bCBT for MDD. This effect was not observed for TAU. These findings suggest that special attention to sleep disturbance symptoms might be warranted when MDD is treated with bCBT. Future studies should investigate the effect of implementing modules specifically targeting sleep disturbance symptoms in bCBT for MDD to improve long-term prognosis.

Mobile Diary App Versus Paper-Based Diary Cards for Patients With Borderline Personality Disorder: Economic Evaluation.

BACKGROUND: The cost-effectiveness of using a mobile diary app as an adjunct in dialectical behavior therapy (DBT) in patients with borderline personality disorder is unknown. OBJECTIVE: This study aims to perform an economic evaluation of a mobile diary app compared with paper-based diary cards in DBT treatment for patients with borderline personality disorder in a psychiatric outpatient facility. METHODS: This study was conducted alongside a pragmatic, multicenter, randomized controlled trial. The participants were recruited at 5 Danish psychiatric outpatient facilities and were randomized to register the emotions, urges, and skills used in a mobile diary app or on paper-based diary cards. The participants in both groups received DBT delivered by the therapists. A cost-consequence analysis with a time horizon of 12 months was performed. Consequences included quality-adjusted life years (QALYs), depression severity, borderline severity, suicidal behavior, health care use, treatment compliance, and system usability. All relevant costs were included. Focus group interviews were conducted with patients, therapists, researchers, and industry representatives to discuss the potential advantages and disadvantages of using a mobile diary app. RESULTS: A total of 78 participants were included in the analysis. An insignificantly higher number of participants in the paper group dropped out before the start of treatment (P=.07). Of those starting treatment, participants in the app group had an average of 37.1 (SE 27.55) more days of treatment and recorded an average of 3.16 (SE 5.10) more skills per week than participants in the paper group. Participants in both groups had a QALY gain and a decrease in depression severity, borderline severity, and suicidal behavior. Significant differences were found in favor of the paper group for both QALY gain (adjusted difference -0.054; SE 0.03) and reduction in depression severity (adjusted difference -1.11; SE 1.57). The between-group difference in total costs ranged from US $107.37 to US $322.10 per participant during the 12 months. The use of services in the health care sector was similar across both time points and groups (difference: psychiatric hospitalization <5 and <5; general practice -1.32; SE 3.68 and 2.02; SE 3.19). Overall, the patients showed high acceptability and considered the app as being easy to use. Therapists worried about potential negative influences on the therapist-patient interaction from new work tasks accompanying the introduction of the new technology but pointed at innovation potential from digital database registrations. CONCLUSIONS: This study suggests both positive and negative consequences of mobile diary apps as adjuncts to DBT compared with paper diary cards. More research is needed to draw conclusions regarding its cost-effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov NCT03191565; http://clinicaltrials.gov/ct2/show/NCT03191565. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/17737.

Dimensionality of the system usability scale among professionals using internet-based interventions for depression: a confirmatory factor analysis.

BACKGROUND: The System Usability Scale (SUS) is used to measure usability of internet-based Cognitive Behavioural Therapy (iCBT). However, whether the SUS is a valid instrument to measure usability in this context is unclear. The aim of this study is to assess the factor structure of the SUS, measuring usability of iCBT for depression in a sample of professionals. In addition, the psychometric properties (reliability, convergent validity) of the SUS were tested. METHODS: A sample of 242 professionals using iCBT for depression from 6 European countries completed the SUS. Confirmatory Factor Analysis (CFA) was conducted to test whether a one-factor, two-factor, tone-model or bi-direct model would fit the data best. Reliability was assessed using complementary statistical indices (e.g. omega). To assess convergent validity, the SUS total score was correlated with an adapted Client Satisfaction Questionnaire (CSQ-3). RESULTS: CFA supported the one-factor, two-factor and tone-model, but the bi-factor model fitted the data best (Comparative Fit Index = 0.992, Tucker Lewis Index = 0.985, Root Mean Square Error of Approximation = 0.055, Standardized Root Mean Square Residual = 0.042 (respectively χ2diff (9) = 69.82, p < 0.001; χ2diff (8) = 33.04, p < 0.001). Reliability of the SUS was good (ω = 0.91). The total SUS score correlated moderately with the CSQ-3 (CSQ1 rs = .49, p < 0.001; CSQ2 rs = .46, p < 0.001; CSQ3 rs = .38, p < 0.001), indicating convergent validity. CONCLUSIONS: Although the SUS seems to have a multidimensional structure, the best model showed that the total sumscore of the SUS appears to be a valid and interpretable measure to assess the usability of internet-based interventions when used by professionals in mental healthcare.

Internet-based cognitive behavioral therapy for anxiety in an outpatient specialized care setting: A qualitative study of the patients' experience of the therapy.

Knowledge about user experiences of internet-based cognitive behavioral therapy (iCBT) has mostly been drawn from non-clinical groups or with iCBT offered via self-referral. The present study therefore focused on patients who had undergone iCBT with minimal support while actively awaiting outpatient psychological treatment in the form of face-to-face CBT. To seek out barriers to adherence the study also included patients who had withdrawn from the iCBT treatment before completion. The study was performed in an outpatient clinic for anxiety disorders where twelve participants with a primary diagnosis of either social anxiety disorder or panic disorder were recruited from an ongoing randomized control trial for semi-structured interviews. Statements from the interviews showed that the iCBT treatment was unfavorably compared to the usual face-to-face treatment at the clinic. Despite this, a majority of the interview participants still expressed to have experienced various benefits from the treatment. Some participants did however, experience difficulties putting the materials to practical use. Furthermore, a large majority of the participants expressed a need for additional support, with a strong tendency for non-completers specifically expressing a need for face-to-face contact with a clinician. Implications for future research and implementation of iCBT in clinical practice are discussed.

Guided Internet-Based Cognitive Behavioral Therapy for Adult Depression and Anxiety in Routine Secondary Care: Observational Study.

BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) is a promising new treatment method for depression and anxiety. However, it is important to determine whether its results can be replicated in routine care before its implementation on a large scale. Although many studies have demonstrated the efficacy of iCBT under controlled conditions, only a few studies have investigated its effectiveness in routine care. Furthermore, several effects of iCBT such as treatment effects in routine care are unclear. OBJECTIVE: This study aimed to evaluate the clinical effectiveness of iCBT for depression and anxiety in routine secondary care. METHODS: n a retrospective cohort study, we analysed patients treated for depression or anxiety in a dedicated iCBT clinic in secondary care in Denmark. Patients were examined before treatment and weekly thereafter by using the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-7 scales for the diagnoses of depression and anxiety, respectively. Primary analyses were conducted using a linear mixed-effects model with random slope and intercept. Secondary analyses were conducted using baseline characteristics as predictors (gender, age, highest level of education, occupational status, marital status, psychotropic medication use, consumption of alcohol, and leisure drugs). Additionally, logistic regression analyses were used to predict noncompletion of treatment. RESULTS: A total of 203 (depression, N=60; anxiety, N=143) patients were included. Participants were mainly female (78.3% with depression and 65.7% with anxiety), with a mean age of 36.03 (SD 10.97) years (range, 19-67 years) for patients with depression and 36.80 (SD 13.55) years (range, 19-69 years) for patients with anxiety. The completion rates were 62% (37) and 40% (57) for depression and anxiety treatments, respectively. The primary analyses revealed large and significant reductions in the symptom levels of depression (beta=-6.27, SE 0.83, P<.001, d=1.0) and anxiety (beta=-3.78, SE 0.43, P<.001, d=1.1). High baseline severity of the primary disorder was associated with high treatment gains (r=-0.31 for depression; r=-0.41 for anxiety). In patients with anxiety, high baseline severity also predicted a high risk of noncompletion (odds ratio=1.08, CI=1.01-1.16, P=.03). An increase in the baseline severity of the comorbid disorder slightly increased the risk of noncompletion for both disorders (depression: odds ratio=1.03, CI=1.01-1.06, P=.02; anxiety: odds ratio=1.08, CI=1.01-1.16, P=.03). CONCLUSIONS: iCBT can be clinically effective in routine care. Since depression and anxiety are costly and debilitating disorders that are vastly undertreated, this finding is important. Additionally, iCBT may help bridge the gap between the need for treatment and its provision. Our results are comparable to the within-group results of efficacy and effectiveness studies. Our noncompletion rates are similar to those observed in psychotherapy but are higher than those reported in similar clinics. Multiple factors predicted outcome and noncompletion. However, all predictor effects were statistically weak.

Blended CBT versus face-to-face CBT: a randomised non-inferiority trial.

BACKGROUND: Internet based cognitive behavioural therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (ftf) consultations in a blended format (B-CBT) may produce a new treatment format with multiple benefits from both traditional CBT and iCBT such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and possibly lower threshold to implementation. The primary aim of the present study is to compare directly the clinical effectiveness of B-CBT with face-to-face CBT for adult major depressive disorder. METHODS/DESIGN: The study is designed as a two arm randomised controlled non-inferiority trial comparing blended CBT for adult depression with treatment as usual (TAU). In the blended condition six sessions of ftf CBT is alternated with six to eight online modules (NoDep). TAU is defined as 12 sessions of ftf CBT. The primary outcome is symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Additionally, the study will include an economic evaluation. All participants must be 18 years of age or older and meet the diagnostic criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental disorders 4th edition. Participants are randomised on an individual level by a researcher not involved in the project. The primary outcome is analysed by regressing the three-month follow-up PHQ-9 data on the baseline PHQ-9 score and a treatment group indicator using ancova. A sample size of 130 in two balanced groups will yield a power of at least 80% to detect standardised mean differences above 0.5 on a normally distributed variable. DISCUSSION: This study design will compare B-CBT and ftf CBT in a concise and direct manner with only a minimal of the variance explained by differences in therapeutic content. On the other hand, while situated in routine care, ecological validity is somewhat compromised by the controlled manner in which the study is conducted. TRIAL REGISTRATION: ClinicalTrials.gov NCT02796573 . Registered June 1st 2016. Currently recruiting participants.

Implementing a revised online screening tool in a routine care online clinic treating anxiety and depression.

Introduction: The ItFits implementation toolkit was developed as part of the ImpleMentAll EU Project, to help guide implementation processes. The ItFits toolkit was tested in the online clinic, Internetpsykiatrien, in the Region of Southern Denmark, where it was employed to optimize screening and intake procedures. We hypothesized that a larger proportion of assessed patients would be referred to treatment. Further, we hypothesized the completion rate and effectiveness would increase, as a result of including a more relevant sample. Method: Using the ItFits-toolkit, Internetpsykiatrien developed a revised online screening tool. Data on patient flow and symptom questionnaires was extracted from Internetpsykiatrien six months prior to- and six months after implementation of the revised online screening tool. Results: A total of 1,830 applicants self-referred for treatment during the study period. A significantly lower proportion of patients were referred to treatment after implementation of the revised screening tool (pre-implementation, n = 1,009; post-implementation, n = 821; odds ratio 0.67, 95% CI: 0.51; 0.87). The number of patients that completed treatment increased significantly (pre-implementation: 136/275 [49.45%], post-implementation, n = 102/162 [62.96%]; odds ratio 1.79, 95% CI 1.20; 2.70). The treatment effect was unchanged (B = 0.01, p = .996). Worth noting, the number of patients that canceled their appointment for the video assessment interview decreased drastically. Conclusion: By using the ItFits toolkit for a focused and structured implementation effort, the clinic was able to improve the completion rate, which is an important effect in iCBT. However, contrary to our hypotheses, we did not find an increase in clinical effect, nor a larger ratio being referred to treatment after assessment. The decreased number of referrals for treatment could be a result of increased awareness of inclusion criteria among the clinicians.

Can online and app-based interventions be used by people with diabetes to reduce diabetes distress? A protocol for a scoping review.

INTRODUCTION: Diabetes distress has been defined as "the negative emotional or affective experience resulting from the challenge of living with the demands of diabetes". Diabetes distress affects 20%-25% of individuals living with diabetes and can have negative effects on both diabetes regulation and quality of life. For people living with diabetes distress, innovative tools/interventions such as online or app-based interventions may potentially alleviate diabetes distress in a cost-effective way. The specific research questions of this scoping review are: (1) what are the effects of online or app-based interventions on diabetes distress for adults with type 1 or type 2 diabetes, and (2) what are the characteristics of these interventions (eg, type of intervention, duration, frequency, mode of delivery, underlying theories and working mechanisms)? METHODS AND ANALYSIS: A scoping review will be conducted, using the methodological framework of Arksey and O'Malley along with Levac et al. Eligible studies are: studies of adults ≥18 years old with type 1 or 2 diabetes using an online or app-based intervention and assessing diabetes distress as the primary or secondary outcome. Five databases (Medline, EMBASE, CINAHL, PsycINFO and Scopus) will be searched and is limited to articles written in English, Danish, Norwegian, Swedish or Dutch. Two reviewers will independently screen potentially eligible studies in Covidence, select studies, and together chart data, collate, summarise, and report the results. We will adhere to the Preferred reporting Items for Systematic Reviews and Meta-Analysis for Scoping Reviews (PRISMA-ScR). ETHICS AND DISSEMINATION: The scoping review has been exempt from full ethical review by the Regional Committees on Health Research Ethics for Southern Denmark (case number: S-20232000-88). The results of the review will be published in a peer-reviewed journal and presented at relevant conferences and workshops with relevant stakeholders.

Days between sessions predict attrition in text-based internet intervention of Binge Eating Disorder.

Background: The number of days between treatment sessions is often overlooked as a predictor of attrition in psychotherapy. In text-based Internet interventions, days between sessions may be a simple yet powerful predictor of attrition. Objective: We hypothesized that a larger number of days between sessions increased the likelihood of attrition among participants with Binge Eating Disorder (BED) in a 12-session Internet-based cognitive behavioral therapy (iCBT) program. Participants could work on the sessions whenever convenient for them and received written support from a psychologist. Material and methods: We compared 201 adult participants with mild to moderate BED (85 non-completers and 116 completers) on the number of days between sessions to predict attrition rates. Results: Mixed model binomial logistic regression showed that non-completers spent significantly more days between sessions across the first four treatment sessions (1-4) when controlling for age, gender, and intake measures of BMI, BED, overall health status (EQ VAS), and depression symptoms (MDI) (OR = 1.042, p < .001). Age (OR = 0.976, p < .001) and EQ VAS (OR = 0.984, p < .001) were also significant. The risk of attrition increased by 4.2 % for each additional day participants spent completing a session.A receiver operating characteristic (ROC) curve analysis showed that classification accuracy increased across sessions from 61.1 % in session 1 and 65.7 % in session 2 to 68.8 % in session 3 and 73.2 % in session 4. The optimal cut-off point in session 4 was 17.5 days, which detected 60.4 % of non-completers (sensitivity) and 78.4 % of completers (specificity).An exploratory repeated measures of ANOVA of days between sessions showed a significant within-subjects effect, where both non-completers and completers spent more days between sessions as they progressed from sessions 1 through 4 (F = 20.54, df = 3, p < .001). There was no interaction effect, suggesting that the increase in slope did not differ between non-completers and completers. Conclusions: Participants spending more days between sessions are at increased risk of dropping out of treatment. This may have important implications for identifying measures to reduce attrition, e.g., intensifying interventions through automated reminders or therapist messages. Our findings may have important transdiagnostic implications for text-based Internet interventions. Further studies should investigate the predictive value of days between sessions in other diagnoses.

Therapist perceptions of the implementation of a new screening procedure using the ItFits-toolkit in an iCBT routine care clinic: A mixed-methods study using the consolidated framework for implementation research.

Introduction: This study investigates the implementation of a new, more automated screening procedure using the ItFits-toolkit in the online clinic, Internet Psychiatry (iPsych) (www.internetpsykiatrien.dk), delivering guided iCBT for mild to moderate anxiety and depressive disorders. The study focuses on how the therapists experienced the process. Methods: Qualitative data were collected from semi-structured individual interviews with seven therapists from iPsych. The interviews were conducted using an interview guide with questions based on the Consolidated Framework for Implementation Research (CFIR). Quantitative data on the perceived level of normalization were collected from iPsych therapists, administrative staff, and off-site professionals in contact with the target demographic at 10-time points throughout the implementation. Results: The therapists experienced an improvement in the intake procedure. They reported having more relevant information about the patients to be used during the assessment and the treatment; they liked the new design better; there was a better alignment of expectations between patients and therapists; the patient group was generally a better fit for treatment after implementation; and more of the assessed patients were included in the program. The quantitative data support the interview data and describe a process of normalization that increases over time. Discussion: The ItFits-toolkit appears to have been an effective mediator of the implementation process. The therapists were aided in the process of change, resulting in an enhanced ability to target the patients who can benefit from the treatment program, less expenditure of time on the wrong population, and more satisfied therapists.

Measuring Cognitive Abilities in the Wild: Validating a Population-Scale Game-Based Cognitive Assessment.

Rapid individual cognitive phenotyping holds the potential to revolutionize domains as wide-ranging as personalized learning, employment practices, and precision psychiatry. Going beyond limitations imposed by traditional lab-based experiments, new efforts have been underway toward greater ecological validity and participant diversity to capture the full range of individual differences in cognitive abilities and behaviors across the general population. Building on this, we developed Skill Lab, a novel game-based tool that simultaneously assesses a broad suite of cognitive abilities while providing an engaging narrative. Skill Lab consists of six mini-games as well as 14 established cognitive ability tasks. Using a popular citizen science platform (N = 10,725), we conducted a comprehensive validation in the wild of a game-based cognitive assessment suite. Based on the game and validation task data, we constructed reliable models to simultaneously predict eight cognitive abilities based on the users' in-game behavior. Follow-up validation tests revealed that the models can discriminate nuances contained within each separate cognitive ability as well as capture a shared main factor of generalized cognitive ability. Our game-based measures are five times faster to complete than the equivalent task-based measures and replicate previous findings on the decline of certain cognitive abilities with age in our large cross-sectional population sample (N = 6369). Taken together, our results demonstrate the feasibility of rapid in-the-wild systematic assessment of cognitive abilities as a promising first step toward population-scale benchmarking and individualized mental health diagnostics.

Text based internet intervention of Binge Eating Disorder (BED): Words per message is associated with treatment adherence.

Background: Some evidence suggests that in internet-based cognitive behavioral therapy (iCBT) the likelihood of adherence is increased when patients write longer messages to the therapist in the program. This association has not previously been investigated in iCBT for Binge Eating Disorder (BED). Objective: In this study, we hypothesized that the number of words written by patients with mild to moderate BED was associated with increased likelihood of treatment completion in a text-based iCBT program. Material and methods: We compared 143 BED patients (92 completers and 51 non-completers) on the number of messages and words written to their therapist during the treatment. Results: Completers wrote significantly more words per message (words/message) than non-completers. The results remained significant after controlling for gender, age, educational level, marital status, children, source of income and intake measures of BED, BMI and depression symptoms (Wald = 14.48, p < .001). The odds ratio of completion increased by 1.5% for each additional word patients wrote per message (OR = 1.015). The model showed a 72.4% classification accuracy, and an optimal cut-off point of 68.99 words/message for differentiating completers and non-completers. The model accurately identified 80.9% of completers (sensitivity) and 54.9% of non-completers (specificity). Conclusions: The number of words/message patients write may have important implications for ascertaining likelihood of adherence and improving adherence rates. From a clinical perspective, therapists should encourage patients to use the option of writing messages to the therapist. Words/message may prove to be a transdiagnostic predictor of treatment adherence in text based iCBT.

Economic evaluation alongside a randomized controlled trial of blended cognitive-behavioral therapy for patients suffering from major depressive disorder.

OBJECTIVE: This study aimed to investigate the cost-effectiveness of blended cognitive-behavioral therapy (CBT) compared to standard CBT for adult patients suffering from major depressive disorder (MDD). DESIGN: A cost-utility analysis alongside the randomized controlled ENTER trial. SETTING: Center for Telepsychiatry, Mental Health Services in the Region of Southern Denmark, Denmark. PARTICIPANTS: The study included 76 patients suffering from MDD. INTERVENTIONS: The patients in the intervention group received blended CBT treatment comprising a combination of online modules and face-to-face consultations with a psychologist. The patients in the control group received standard CBT treatment, that is, solely face-to-face consultations with a psychologist. The treatment period was 12 weeks. OUTCOME MEASURES: Cost-effectiveness was reported as incremental cost-effectiveness ratio. A micro-costing approach was applied to evaluate the savings derived. Changes in quality-adjusted life-years (QALYs) were estimated using the EuroQol 5-Dimensions 5-Levels questionnaire at the baseline and the six-month follow-up. RESULTS: Data for 74 patients were included in the primary analysis. The adjusted QALY difference between blended CBT and standard CBT was -0.0291 (95% CI: -0.0535 to -0.0047), and the adjusted difference in costs was -£226.32 (95% CI: -300.86 to -151.77). Blended CBT was estimated to have a 6.6% and 3.1% probability of being cost-effective based on thresholds of £20,000 and £30,000. CONCLUSION: Compared to standard CBT, blended CBT represents a cost-saving but also a loss in QALYs for patients suffering from MDD. However, results should be carefully interpreted, given the small sample size. Future research involving larger replication studies focusing on other aspects of blended CBT with more patient involvement is advised. TRIAL REGISTRATION NUMBER: ClinicalTrial.gov: S-20150150.

Early development of treatment motivation predicts adherence and symptom reduction in an internet-based guided self-help program for binge eating disorder.

Objective: Lack of motivation is widely acknowledged as a significant factor in treatment discontinuity and poor treatment outcomes in eating disorders. Treatment adherence is lower in internet-based treatment. The current study aimed to assess the relationship between treatment motivation and treatment outcomes in an internet-based therapist-guided intervention for Binge Eating Disorder (BED). Method: Adults (N = 153) with mild to moderate symptoms of BED participated in a 10-session internet-based treatment program. Baseline and between-session scores of "Readiness to change" and "Belief in change" were used to predict treatment completion and eating disorder symptom reduction (EDE-Q Global, BED-Q, and weekly number of binge eating episodes) at post-treatment. Results: Baseline treatment motivation could not predict treatment completion or symptom reduction. Early measures of treatment motivation (regression slope from sessions 1-5) significantly predicted both treatment completion and post-treatment symptom reduction. "Belief in change" was the strongest predictor for completing treatment (OR = 2.18, 95%-CI: 1.06, 4.46) and reducing symptoms (EDE-Q Global: B = -0.53, p = 0.001; number of weekly binge eating episodes: B = 0.81, p < 0.01). Discussion: The results indicated that patients entering online treatment for BED feel highly motivated. However, baseline treatment motivation could not significantly predict treatment completion, which contradicts previous research. The significant predictive ability of early measures of treatment motivation supports the clinical relevance of monitoring the development of early changes to tailor and optimize individual patient care. Further research is needed to examine treatment motivation in regard to internet-based treatment for BED with more validated measures.

Online consultations in mental healthcare: Modelling determinants of use and experience based on an international survey study at the onset of the pandemic.

Introduction: While online consultations have shown promise to be a means for the effective delivery of high-quality mental healthcare and the first implementations of these digital therapeutic contacts go back nearly two decades, uptake has remained limited over the years. The onset of the COVID-19 pandemic dramatically altered this relative standstill and created a unique turning point, with a massive amount of both professionals and clients having first hands-on experiences with technology in mental healthcare. Objective: The current study aimed to document the uptake of online consultations and explore if specific characteristics of mental health professionals across and beyond Europe could predict this. Methods: An international survey was designed to assess mental health professionals' (initial) experiences with online consultations at the onset of the pandemic: their willingness to make use of them and their prior and current experiences, alongside several personal characteristics. Logistic mixed-effects models were used to identify predictors of the use of online consultations, personal experience with this modality, and the sense of telepresence. Results: A total of 9115 healthcare professionals from 73 countries participated of which about two-thirds used online consultations during the initial COVID-19 outbreak. The current study identifies multiple determinants relating to the use and experience of online consultations, including the professionals' age, experience with the technology before the outbreak, the professional context, and training. Conclusions: Despite strong evidence supporting the relevance of training in digital mental health, this is clearly still lacking. Nevertheless, the COVID-19 pandemic presented a first, and potentially transformative, experience with online consultations for many healthcare professionals. The insights from this study can help support professionals and, importantly, (mental) healthcare organisations to create optimal circumstances for selective and high-quality continued use of online consultations.

The working alliance in blended versus face-to-face cognitive therapy for depression: A secondary analysis of a randomized controlled trial.

INTRODUCTION: We explored the working alliance as measured by both clients and therapists. The working alliance has been known to predict the outcome of psychotherapy and is often considered an important common factor. This study raised the question of how to conceptualize the working alliance in the blended format. METHODS: This was an exploratory study derived from a randomized controlled trial comparing bCBT and face-to-face cognitive behavioural therapy (ftf CBT) on depression. The change in depressive symptoms was measured with the Patient Health Questionnaire (PHQ-9) and the working alliance was measured using the Working Alliance Inventory. ANALYSES: Correlation coefficients were calculated for the working alliance as reported by clients and therapists, working alliance was then examined at item and dimension level (task, bond, goal). Linear regression models were applied to investigate the predictive value of the working alliance on treatment outcome. Interaction between the level of working alliance and treatment condition was also considered. RESULTS: Client and therapist working alliance ratings correlated at r = 0.44 and clients rated the working alliance higher than therapists (x̄ clients  = 48.6, x̄ therapists  = 44.6). ftf CBT and bCBT had comparable joint working alliance ratings (x̄ ftf  = 46.4, x̄ bCBT  = 46.8). Items had little deviation apart from item 4 with high positive values. The level of working alliance from the total sample did not significantly predict outcome based on the client's perspective. Contrarily, seen from the therapist's perspective, it did (b = 0.00, p = .044). Using the mean from these predictors as a composite variable, was also significant (b = 0.00, p = .039, R2 adj  = 0.07). There was no significant interaction with treatment condition. DISCUSSION: Clients and therapists may lay emphasis on different aspects of the working alliance. The finding that therapist-rated working alliance was better than client working alliance at predicting outcome went against common findings; this pattern may be specific to bCBT. CONCLUSION: Clients rated the working alliance slightly higher than therapists on average. Clients and therapists as well as treatment conditions had different profiles on dimension deviations. Therapist ratings of the working alliance appeared to better predict treatment outcome than client ratings. Joint working alliance predicted outcome using client and therapist composite means. The working alliance was equally strong in ftf CBT and bCBT. The absence of interaction with treatment condition indicated that the working alliance was equally predictive of outcome in ftf CBT as in bCBT.

Brain+ AlcoRecover: A Randomized Controlled Pilot-Study and Feasibility Study of Multiple-Domain Cognitive Training Using a Serious Gaming App for Treating Alcohol Use Disorders.

Background: Patients with alcohol use disorder (AUD) exhibit deficits in various cognitive domains, including executive functioning, working memory, and learning and memory, which impede the effectiveness of conventional AUD treatment and enhance relapse. Mobile health (mHealth) services are promising in terms of delivering cognitive training in gamified versions. So far, studies examining the effects of mHealth-based cognitive training in AUD patients have, however, focused on specific rather than multiple cognitive domains and overlooked the importance of clinical outcomes. Furthermore, research has yet to investigate the acceptability and feasibility of this type of cognitive training. Aims: The aims of this pilot study are to examine (1) whether using smartphone-based, multi-domain cognitive training with gamified elements as part of conventional treatment for AUD indicate effect, and (2) whether the intervention is acceptable and feasible as a part of conventional treatment for AUD. Methods: Patients from the alcohol outpatient clinic, Odense Municipality, Denmark will be invited to participate in the study on a consecutive basis until a total of 60 patients have been recruited. The study will be performed as a combined parallel randomized controlled trial (RCT) and qualitative feasibility study. The patients will be randomly assigned to one of two groups. The intervention group (n = 30) will receive smartphone-based, multi-domain cognitive training with gamified elements together with treatment as usual (TAU). The active control group (n = 30) will receive a sham version of the same cognitive training together with TAU. Cognitive outcomes will be assessed via the training application at baseline and post-treatment. Clinical outcomes will be assessed at baseline, post-treatment, and at 6-month follow-up using the Addiction Severity Index. Furthermore, the 30 patients randomized to the intervention group will be invited to participate in the second phase, that is the feasibility study, at post-treatment. A questionnaire inquiring about the use of mHealth treatment in general will be administered. Further, feedback regarding functionality and meaningfulness of the application in addition to other qualitative aspects relating to the use of the application will be collected. The patients will also be asked to provide suggestions about how to improve and potentially implement the tool. Implications: It is anticipated that this pilot study will provide tentative evidence for the effectiveness of smartphone-based, multi-domain cognitive training as well as information about the usability and feasibility of this type of training, including acceptability and compliance. The study will also contribute with feedback derived from the patients about how to improve and implement the tool. If promising, the findings will be used to plan a large-scale RCT. Since cognitive deficits are not addressed in current treatments for AUD, gamified cognitive training delivered through smartphones may increase the effectiveness of current treatment for AUD as well as introduce more mHealth-based treatment that is both accessible and cost-effective.