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.

The Moderating Role of Sex in the Relation between Cue-Induced Craving and Resting-State Functional Connectivity in the Salience Network of Non-Clinically Diagnosed Drinkers.

INTRODUCTION: Previous research indicates a relation between craving and increased connectivity in the resting-state salience network. However, the link between cue-induced craving and connectivity in the salience network remains unclear. Further investigation is needed to understand the effect of sex on the relationship between cue-induced craving and the salience network. We investigated the role of sex in the association between the resting-state functional connectivity (RSFC) salience network and subjective cue-induced craving. METHODS: Twenty-six males (mean age = 25.3) and 23 females (mean age = 26.0), with a score of 12 or higher on the alcohol use disorder identification test, were included in the current study. No significant difference in age was observed between males and females. Participants underwent a resting-state MRI scan for 6 min. Following the MRI scan, participants completed an alcohol cue-exposure task for 5.5 min to assess cue-induced craving using the desire to drink alcohol questionnaire. We applied independent component analysis methods to determine functional connectivity within the salience network. Subsequently, we investigated how cue-induced craving is related to the salience network's RSFC and if this relationship is moderated by sex. RESULTS: The association between the salience network and cue-induced craving was not statistically significant nor did we find a moderating effect for sex. CONCLUSION: The null findings in the study may be explained by a lack of power. Alternatively, alcohol use sex disparities may be more prevalent in the recreational/impulsive stage, whereas participants in our study were in the later stage of addiction.

Online therapy: an added value for inpatient routine care? Perspectives from mental health care professionals.

Internet-delivered interventions can be effective in treating mental disorders. However, their rate of use in German psychiatric inpatient routine care is low. The current study aimed to investigate the attitude of mental health care professionals working in inpatient care regarding internet-delivered interventions, including presumed benefits, barriers and facilitators. In total, 176 health professionals from ten inpatient psychiatric hospitals throughout Germany were surveyed on site. The professionals' attitude towards internet-delivered interventions in inpatient care was assessed by an adapted version of the 'Attitude toward Telemedicine in Psychiatry and Psychotherapy' (ATTiP) questionnaire. To identify benefits, barriers and facilitators, we developed open-response questions that were based on the 'Unified Theory of Acceptance and Use of Technology' (UTAUT) and analyzed by a qualitative content analysis. Professionals reported little experience or knowledge about internet-delivered interventions. Their attitude towards internet-delivered interventions in psychiatric inpatient care was rather indifferent. The most frequently mentioned potential benefits were an optimised treatment structure and patient empowerment; the most frequently anticipated barriers were too severe symptoms of patients, the feared neglect of face-to-face contacts and insufficient technical equipment; and the most frequently mentioned facilitators were high usability of the internet-based intervention, a sufficient functional level of the patient and further education of staff. For successful implementation in the inpatient sector, internet-delivered interventions must be adapted to the special needs of severely mentally ill patients and to the hospital management systems and workflow. In addition, technical preconditions (internet access, devices) must be met. Last, further education of mental health care professionals is needed.

Organisational implementation climate in implementing internet-based cognitive behaviour therapy for depression.

BACKGROUND: Internet-based Cognitive Behaviour Therapy (iCBT) for depression have been implemented in routine care across Europe in varying ways, at various scales and with varying success. This study aimed to advance our understanding of organisational implementation climate from the perspectives of implementers and mental health service deliverers. METHODS: Qualitative and quantitative methods were combined to study the concept of organisational implementation climate in mental health care settings. Based on concept mapping, a qualitative workshop with implementers was used to conceptualise organisational implementation climate for optimizing iCBT use in routine practice. Service deliverers involved in the provision of iCBT were invited to participate in an explorative cross-sectional survey assessing levels of satisfaction and usability of iCBT, and organisational implementation climate in implementing iCBT. The two methods were applied independently to study viewpoints of implementers as well as service deliverers. Corresponding to the explorative nature of the study, inductive reasoning was applied to identify patterns and develop a reasonable explanation of the observations made. Correlative associations between satisfaction, usability and implementation climate were explored. RESULTS: Sixteen implementers representing fourteen service delivery organisations across Europe participated in the workshop. The top-three characteristics of a supportive organisational implementation climate included: (1) clear roles and skills of implementers, (2) feasible implementation targets, and (3) a dedicated implementation team. The top-three tools for creating a supportive implementation climate included: (1) feedback on job performance, (2) progress monitoring in achieving implementation targets, and (3) guidelines for assessing the impact of iCBT. The survey (n=111) indicated that service providers generally regarded their organisational implementation climate as supportive in implementing iCBT services. Organisational implementation climate was weakly associated with perceived usability and moderately with satisfaction with iCBT services. CONCLUSIONS: Organisational implementation climate is a relevant factor to implementers and service deliverers in implementing iCBT in routine care. It is not only an inherent characteristic of the context in which implementation takes place, it can also be shaped to improve implementation of iCBT services. Future research should further theorise organisational implementation climate and empirically validate the measurement instruments such as used in this study.

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.

Challenges in Recruiting University Students for Web-Based Indicated Prevention of Depression and Anxiety: Results From a Randomized Controlled Trial (ICare Prevent).

BACKGROUND: Depression and anxiety are common mental health conditions in college and university student populations. Offering transdiagnostic, web-based prevention programs such as ICare Prevent to those with subclinical complaints has the potential to reduce some barriers to receiving help (eg, availability of services, privacy considerations, and students' desire for autonomy). However, uptake of these interventions is often low, and accounts of recruitment challenges are needed to complement available effectiveness research in student populations. OBJECTIVE: The aims of this study were to describe recruitment challenges together with effective recruitment strategies for ICare Prevent and provide basic information on the intervention's effectiveness. METHODS: A 3-arm randomized controlled trial was conducted in a student sample with subclinical symptoms of depression and anxiety on the effectiveness of an individually guided (human support and feedback on exercises provided after each session, tailored to each participant) and automatically guided (computer-generated messages provided after each session, geared toward motivation) version of ICare Prevent, a web-based intervention with transdiagnostic components for the indicated prevention of depression and anxiety. The intervention was compared with care as usual. Descriptive statistics were used to outline recruitment challenges and effective web-based and offline strategies as well as students' use of the intervention. A basic analysis of intervention effects was conducted using a Bayesian linear mixed model, with Bayes factors reported as the effect size. RESULTS: Direct recruitment through students' email addresses via the central student administration was the most effective strategy. Data from 35 participants were analyzed (individually guided: n=14, 40%; automatically guided: n=8, 23%; care as usual: n=13, 37%). Use of the intervention was low, with an average of 3 out of 7 sessions (SD 2.9) completed. The analyses did not suggest any intervention effects other than anecdotal evidence (all Bayes factors10≤2.7). CONCLUSIONS: This report adds to the existing literature on recruitment challenges specific to the student population. Testing the feasibility of recruitment measures and the greater involvement of the target population in their design, as well as shifting from direct to indirect prevention, can potentially help future studies in the field. In addition, this report demonstrates an alternative basic analytical strategy for underpowered randomized controlled trials. TRIAL REGISTRATION: International Clinical Trials Registry Platform NTR6562; https://tinyurl.com/4rbexzrk. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-018-2477-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.

Toward an Objective Assessment of Implementation Processes for Innovations in Health Care: Psychometric Evaluation of the Normalization Measure Development (NoMAD) Questionnaire Among Mental Health Care Professionals.

BACKGROUND: Successfully implementing eMental health (eMH) interventions in routine mental health care constitutes a major challenge. Reliable instruments to assess implementation progress are essential. The Normalization MeAsure Development (NoMAD) study developed a brief self-report questionnaire that could be helpful in measuring implementation progress. Based on the Normalization Process Theory, this instrument focuses on 4 generative mechanisms involved in implementation processes: coherence, cognitive participation, collective action, and reflexive monitoring. OBJECTIVE: The aim of this study was to translate the NoMAD questionnaire to Dutch and to confirm the factor structure in Dutch mental health care settings. METHODS: Dutch mental health care professionals involved in eMH implementation were invited to complete the translated NoMAD questionnaire. Confirmatory factor analysis (CFA) was conducted to verify interpretability of scale scores for 3 models: (1) the theoretical 4-factor structure, (2) a unidimensional model, and (3) a hierarchical model. Potential improvements were explored, and correlated scale scores with 3 control questions were used to assess convergent validity. RESULTS: A total of 262 professionals from mental health care settings in the Netherlands completed the questionnaire (female: 81.7%; mean age: 45 [SD=11]). The internal consistency of the 20-item questionnaire was acceptable (.62≤alpha≤.85). The theorized 4-factor model fitted the data slightly better in the CFA than the hierarchical model (Comparative Fit Index=0.90, Tucker Lewis Index=0.88, Root Mean Square Error of Approximation=0.10, Standardized Root Mean Square Residual=0.12, χ22=22.5, P≤.05). However, the difference is small and possibly not outweighing the practical relevance of a total score and subscale scores combined in one hierarchical model. One item was identified as weak (λCA.2=0.10). A moderate-to-strong convergent validity with 3 control questions was found for the Collective Participation scale (.47≤r≤.54, P≤.05). CONCLUSIONS: NoMAD's theoretical factor structure was confirmed in Dutch mental health settings to acceptable standards but with room for improvement. The hierarchical model might prove useful in increasing the practical utility of the NoMAD questionnaire by combining a total score with information on the 4 generative mechanisms. Future research should assess the predictive value and responsiveness over time and elucidate the conceptual interpretability of NoMAD in eMH implementation practices.

The effects of psychotherapy for depression on anxiety symptoms: a meta-analysis.

BACKGROUND: More than half of patients who present with depressive disorders also have elevated comorbid anxiety symptoms. Given the high comorbidity between these disorders, it is important to understand the extent that psychotherapies for depression additionally ameliorate symptoms of anxiety. METHODS: Systematic searches were conducted in PubMed, PSYCinfo, EMBASE, and the Cochrane Registry of Controlled Trials. Included studies were randomized controlled trials that compared psychotherapy compared with a control condition for the treatment of adults with a primary diagnosis or elevated symptoms of depression and that examined the effects of treatment on anxiety outcomes. Acute phase depression and anxiety (continuous measure) outcomes were extracted. Effect sizes were calculated by subtracting the average post-treatment scores of the psychotherapy group from the average post-treatment scores of the comparison group divided by the pooled standard deviation. RESULTS: Fifty-two studies of varying quality met the inclusion criteria. Pooled effect sizes showed that anxiety outcomes were significantly lower in the psychotherapy conditions than in control conditions at post-treatment [g = 0.52; 95% confidence interval (CI) 0.44-0.60; NNT (numbers-needed-to-treat) = 3.50]. Moderate heterogeneity was observed (I2 = 55%, 95% CI 40-66). Bivariate metaregression analysis revealed a significant association between depression and anxiety effect sizes at post-treatment Longer-term follow-ups of up to 14 months post-baseline showed indications for a small lasting effect of psychotherapy on anxiety outcomes (g = 0.27). CONCLUSIONS: This meta-analysis provides evidence that psychotherapy aimed at depression can also reduce anxiety symptoms in relation to control conditions.

Is self-guided internet-based cognitive behavioural therapy (iCBT) harmful? An individual participant data meta-analysis.

BACKGROUND: Little is known about potential harmful effects as a consequence of self-guided internet-based cognitive behaviour therapy (iCBT), such as symptom deterioration rates. Thus, safety concerns remain and hamper the implementation of self-guided iCBT into clinical practice. We aimed to conduct an individual participant data (IPD) meta-analysis to determine the prevalence of clinically significant deterioration (symptom worsening) in adults with depressive symptoms who received self-guided iCBT compared with control conditions. Several socio-demographic, clinical and study-level variables were tested as potential moderators of deterioration. METHODS: Randomised controlled trials that reported results of self-guided iCBT compared with control conditions in adults with symptoms of depression were selected. Mixed effects models with participants nested within studies were used to examine possible clinically significant deterioration rates. RESULTS: Thirteen out of 16 eligible trials were included in the present IPD meta-analysis. Of the 3805 participants analysed, 7.2% showed clinically significant deterioration (5.8% and 9.1% of participants in the intervention and control groups, respectively). Participants in self-guided iCBT were less likely to deteriorate (OR 0.62, p < 0.001) compared with control conditions. None of the examined participant- and study-level moderators were significantly associated with deterioration rates. CONCLUSIONS: Self-guided iCBT has a lower rate of negative outcomes on symptoms than control conditions and could be a first step treatment approach for adult depression as well as an alternative to watchful waiting in general practice.

Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care: study protocol for a randomised non-inferiority trial.

BACKGROUND: Data from primary health care in Spain show a high prevalence of the major depressive disorder. Blended treatment (combination of face-to-face and online components) seems to be a very promising tool for the optimization and dissemination of psychological treatments in a cost-effective form. Although there is growing data that confirm the advantages of blended therapies, few studies have analyzed their application in regular clinical practice. The objective of the present paper is to describe the protocol for a clinical study aimed at exploring the clinical and cost-effectiveness of a blended cognitive behavioral therapy (b-CBT) for depression, compared to treatment as usual (TAU) in a primary health care setting. METHODS: A two-arm randomised controlled non-inferiority trial will be carried out, with repeated measures (baseline, 3 months, 6 months, and 12 months) under two conditions: b-CBT and TAU. The b-CBT program will consist in three face-to-face sessions and eight online sessions. The TAU is defined as the routine care delivered by the general practitioner for the treatment of depression in primary care. The primary outcome is a symptomatic change of depressive symptoms on the patient-health questionnaire (PHQ-9). Other secondary outcomes will be considered (e.g., quality of life, treatment preference). 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. 156 participants will be recruited (78 per arm). DISCUSSION: It is expected that b-CBT is clinically non-inferior when compared to TAU. This is the first study in Spain to use a b-CBT format in primary and specialized care, and this format could be an efficacious and cost-effective therapeutic strategy for the treatment of depression. TRIAL REGISTRATION: ClinicalTrials.gov NCT02361684. Registered on 8 January 2015. Currently recruiting participants.

Follow-up over 20 months confirms gains of online behavioural training in frequent episodic migraine.

Aim This study examined the change over 20 months in 178 participants with frequent episodic migraine under adequate treatment as usual, who had completed online behavioural training (oBT) in migraine self-management either directly (group 1, n = 120) or after 10 months of watchful waiting (group 2, n = 58). Methods Participants completed questionnaires and an online headache diary and migraine monitor following the International Classification of Headache Disorders at T0 (baseline), T1 (post-training), T2 (6-month follow-up; extended baseline in group 2), T3 (post-training, group 2 only) and T4 (group 1: 16-month follow-up; group 2: 6-month follow-up). Statistical analyses were conducted on the observed data without imputation of missing observations. Results Both groups were highly comparable. The data over time revealed benefits in response to oBT, with significant between-group differences in the change achieved in the training episodes T2-T0 (group 1) and T4-T2 (group 2). Improved attack frequency ( M = -23%) was higher in participants with more (i.e. 4-6) attacks per month at baseline, and the effects of oBT were durable over 16 months of follow-up. Conclusions oBT is beneficial in frequent episodic migraine, which deserves special efforts in care. Self-management variants such as oBT reach patients easily and supplement these efforts with durable results.

Internet and mobile interventions for depression: Opportunities and challenges.

BACKGROUND: The Internet offers several new ways of developing, implementing, and disseminating evidence-based interventions for depression. METHODS: In this paper, we narratively synthesized the evidence showing that Internet-based therapies are effective in treating depression. RESULTS: In the past decade, a considerable number of psychological treatments have been developed for the treatment of depression and several hundreds of randomized controlled trials have been conducted, showing that these interventions are effective and that there are no major differences in effects between therapies. Several meta-analyses show that Internet-based treatments are also effective in depression. Direct comparisons with face-to-face treatments do not indicate that there are relevant differences between Internet-based and face-to-face treatment formats. The challenge for the near future is to examine how these treatments can be integrated in mental health care. Major opportunities are in preventive services, primary care, specialized mental health care, and in patients with comorbid general medical disorders. New technological innovations through the smartphone, serious gaming, avatars, augmented reality, and virtual reality will give further possibilities to simplify and perhaps increase the effects of treatments. CONCLUSIONS: The Internet offers many possibilities to increase access to evidence-based psychological treatments of depression. New technological may further improve access and, perhaps, the effects of treatments.

Effect of psychotherapy for depression on quality of life: meta-analysis.

BACKGROUND: Several meta-analyses have shown that psychotherapy is effective for reducing depressive symptom severity. However, the impact on quality of life (QoL) is as yet unknown. AIMS: To investigate the effectiveness of psychotherapy for depression on global QoL and on the mental health and physical health components of QoL. METHOD: We conducted a meta-analysis of 44 randomised clinical trials comparing psychotherapy for adults experiencing clinical depression or elevated depressive symptoms with a control group. We used subgroup analyses to explore the influence of various study characteristics on the effectiveness of treatment. RESULTS: We detected a small to moderate effect size (Hedges' g = 0.33, 95% CI 0.24-0.42) for global QoL, a moderate effect size for the mental health component (g = 0.42, 95% CI 0.33-0.51) and, after removing an outlier, a small but statistically significant effect size for the physical health component (g = 0.16, 95% CI 0.05-0.27). Multivariate meta-regression analyses showed that the effect size of depressive symptoms was significantly related to the effect size of the mental health component of QoL. The effect size of depressive symptoms was not related to global QoL or the physical health component. CONCLUSIONS: Psychotherapy for depression has a positive impact on the QoL of patients with depression. Improvements in QoL are not fully explained by improvements in depressive symptom severity.

Determinants of help-seeking behavior in depression: a cross-sectional study.

BACKGROUND: Although evidence-based and effective treatments are available for people with depression, a substantial number does not seek or receive help. Therefore, it is important to gain a better understanding of the reasons why people do or do not seek help. This study examined what predisposing and need factors are associated with help-seeking among people with major depression. METHODS: A cross-sectional study was conducted in 102 subjects with major depression. Respondents were recruited from the general population in collaboration with three Municipal Health Services (GGD) across different regions in the Netherlands. Inclusion criteria were: being aged 18 years or older, a high score on a screening instrument for depression (K10 > 20), and a diagnosis of major depression established through the Composite International Diagnostic Interview (CIDI 2.1). RESULTS: Of the total sample, 65 % (n = 66) had received help in the past six months. Results showed that respondents with a longer duration of symptoms and those with lower personal stigma were more likely to seek help. Other determinants were not significantly related to help-seeking. CONCLUSIONS: Longer duration of symptoms was found to be an important determinant of help-seeking among people with depression. It is concerning that stigma was related to less help-seeking. Knowledge and understanding of depression should be promoted in society, hopefully leading to reduced stigma and increased help-seeking.

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.

Long-term results of a web-based guided self-help intervention for employees with depressive symptoms: randomized controlled trial.

BACKGROUND: Depressive disorders are highly prevalent in the working population and are associated with excessive costs. The evidence for effective worker-directed interventions for employees with depressive symptoms is limited. Treating employees with depressive symptoms via the Internet before they report sick from work could be beneficial and cost saving. OBJECTIVE: In this study, we tested the effectiveness over the period of 1 year of a Web-based guided self-help intervention, called Happy@Work, for employees with depressive symptoms who were not on sick leave. METHODS: A two-arm randomized controlled trial comparing a worker-directed, Web-based, guided self-help intervention to care as usual (CAU) was carried out. We recruited employees from 6 companies via the company's Intranet and by putting up posters. The inclusion criteria were elevated depressive symptoms as measured by a score ≥16 on the Center for Epidemiologic Studies Depression scale (CES-D) and not being on sick leave. The intervention contained 6 lessons and consisted of problem-solving treatment and cognitive therapy. Participants were asked to submit weekly assignments via the website after completion of a lesson and they received feedback from a coach via the website. Self-report questionnaires on depressive symptoms (CES-D; primary outcome), burnout (Maslach Burnout Inventory, MBI), work performance (Health and Work Performance Questionnaire, HPQ), duration of absenteeism, and anxiety (Hospital Anxiety and Depression Scale, HADS; secondary outcomes), were completed at baseline, posttreatment, and at 6-, and 12-month follow-up. Several subgroup and per-protocol analyses were performed. RESULTS: A total of 231 employees were randomized to either the intervention group (n=116) or to CAU (n=115). Completion of assessments varied between 54%-74%. Improvement in depressive symptoms between baseline and posttreatment was shown in all participants and these effects sustained over time. However, there were no differences between the 2 groups (adjusted regression coefficient=0.46, 95% CI -2.11 to 3.03, P=.72; Cohen's d=0.05). Differences between groups were also not significant for the secondary outcomes. No subgroups were identified to show differences between the groups, nor did we find a between-group effect in the per-protocol analyses. CONCLUSIONS: This study showed that a worker-directed, Web-based, guided self-help intervention was not more effective than CAU in reducing depressive symptoms among employees with depressive symptoms who were not on sick leave over the period of 1 year. An intervention for this specific target group might not be necessary because the recovery in the CAU group was comparable to the intervention group and sustained over a 12-month period. TRIAL REGISTRATION: Nederlands Trial Register (NTR): NTR2993; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2993 (Archived by WebCite at http://www.webcitation.org/6PL9pFC0n).

Short-term effects of a web-based guided self-help intervention for employees with depressive symptoms: randomized controlled trial.

BACKGROUND: Depressive disorders are highly prevalent in the working population and are associated with excessive costs. The evidence for effective worker-directed interventions for employees with depressive symptoms is limited. Treating employees with depressive symptoms before sick leave via the Internet could be beneficial and cost saving. OBJECTIVE: In this study, we developed and tested the effectiveness of a Web-based guided self-help course for employees with depressive symptoms. We report on the posttreatment effectiveness of the intervention. METHODS: This study is a two-arm randomized controlled trial comparing a Web-based guided self-help course to care as usual (CAU). We recruited employees from 6 different companies via the companies' intranet and posters. The main inclusion criterion was elevated depressive symptoms as measured by a score of ≥16 on the Center for Epidemiological Studies Depression scale (CES-D). The intervention (Happy@Work) was based on problem-solving treatment and cognitive therapy and consisted of 6 weekly lessons. Participants were asked to submit their weekly assignment via the website after completion. They subsequently received feedback from a coach via the website. Self-report questionnaires on depressive symptoms (CES-D; primary outcome), anxiety measured by the Hospital Anxiety and Depression Scale (HADS), burnout measured by the Maslach Burnout Inventory (MBI), and work performance measured by the Health and Work Performance Questionnaire (HPQ; secondary outcomes) were completed at baseline and at posttreatment. RESULTS: A total of 231 employees were randomized to either the intervention group (n=116) or CAU (n=115).The posttreatment assessment was completed by 171 (74.0%) participants. Both the intervention and the CAU group showed significant improvements in the primary outcome of depressive symptoms, but no differences between the conditions was found (d=0.16, 95% CI -0.10 to 0.41, P=.29). Significant but small effects in favor of the intervention group were found for anxiety symptoms (d=0.16, 95% CI -0.09 to 0.42, P=.04) and exhaustion (d=0.17, 95% CI -0.09 to 0.43, P=.02). CONCLUSIONS: This study showed that a Web-based guided self-help course for employees with depressive symptoms was not more effective in reducing depressive symptoms among employees than CAU. Large improvements in depressive symptoms in the CAU group were unforeseen and potential explanations are discussed.

Daily stress encounters: Positive emotion upregulation and depressive symptoms.

When it comes to coping with stress, positive emotion upregulation is of utmost importance. Positive emotions have been suggested to be an important resource during stressful times since people try to create and upregulate pleasant emotional states when feeling stressed. Accordingly, individual differences in the ability to generate and savor positive emotional states could also affect one's skills in dealing with stress. In this regard, an important factor might be depression, which is associated with impaired positive emotion regulation. To disentangle the reciprocal influence between perceived stress and positive emotion upregulation, we conducted an Ecological Momentary Assessment study (n = 92) in which we assessed participants' stress levels and use of positive upregulating strategies (attentional deployment, cognitive change, and response modulation) three times a day over 2 weeks. Results from linear mixed-effects models showed that higher levels of perceived stress at one point predicted increased use of positive upregulating strategies from this point to the next which, in turn, resulted in subsequent diminished stress levels. Interaction analyses indicated that participants with higher depressive symptoms implemented upregulating strategies to a lower extent when experiencing intense stress. Furthermore, attentional deployment was less effective in decreasing stress in individuals higher in depression, whereas the other strategies showed comparable or even higher efficacy. Overall, positive emotion upregulation might be regarded as an adaptive tool that helps cope with stress. This mechanism might be altered in people higher in depression, who specifically struggle to implement positive upregulating strategies during times of stress. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Differential mortality rates in major and subthreshold depression: meta-analysis of studies that measured both.

BACKGROUND: Although the association between depression and excess mortality has been well established, it is not clear whether this is greater in major depression than in subthreshold depression. AIMS: To compare excess mortality in major depression with that in subthreshold depression. METHOD: We searched bibliographic databases and included prospective studies in which both major and subthreshold depression were examined at baseline and mortality was measured at follow-up. RESULTS: A total of 22 studies were included. People with major depression had a somewhat increased chance of dying earlier than people with subthreshold depression but this difference was not significant, although there was a trend (relative risk 1.13, 95% CI 0.98-1.30, P = 0.1). The population attributable fraction was 7% for major depression and an additional 7% for subthreshold depression. CONCLUSIONS: Although excess mortality may be somewhat higher in major than in subthreshold depression, the difference is small and the overall impact on excess mortality is comparable.