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.

Cost and Effectiveness of Blended Versus Standard Cognitive Behavioral Therapy for Outpatients With Depression in Routine Specialized Mental Health Care: Pilot Randomized Controlled Trial.

BACKGROUND: Cognitive behavioral therapy (CBT) is an effective treatment, but access is often restricted due to costs and limited availability of trained therapists. Blending online and face-to-face CBT for depression might improve cost-effectiveness and treatment availability. OBJECTIVE: This pilot study aimed to examine the costs and effectiveness of blended CBT compared with standard CBT for depressed patients in specialized mental health care to guide further research and development of blended CBT. METHODS: Patients were randomly allocated to blended CBT (n=53) or standard CBT (n=49). Blended CBT consisted of 10 weekly face-to-face sessions and 9 Web-based sessions. Standard CBT consisted of 15 to 20 weekly face-to-face sessions. At baseline and 10, 20, and 30 weeks after start of treatment, self-assessed depression severity, quality-adjusted life-years (QALYs), and costs were measured. Clinicians, blinded to treatment allocation, assessed psychopathology at all time points. Data were analyzed using linear mixed models. Uncertainty intervals around cost and effect estimates were estimated with 5000 Monte Carlo simulations. RESULTS: Blended CBT treatment duration was mean 19.0 (SD 12.6) weeks versus mean 33.2 (SD 23.0) weeks in standard CBT (P<.001). No significant differences were found between groups for depressive episodes (risk difference [RD] 0.06, 95% CI -0.05 to 0.19), response to treatment (RD 0.03, 95% CI -0.10 to 0.15), and QALYs (mean difference 0.01, 95% CI -0.03 to 0.04). Mean societal costs for blended CBT were €1183 higher than standard CBT. This difference was not significant (95% CI -399 to 2765). Blended CBT had a probability of being cost-effective compared with standard CBT of 0.02 per extra QALY and 0.37 for an additional treatment response, at a ceiling ratio of €25,000. For health care providers, mean costs for blended CBT were €176 lower than standard CBT. This difference was not significant (95% CI -659 to 343). At €0 per additional unit of effect, the probability of blended CBT being cost-effective compared with standard CBT was 0.75. The probability increased to 0.88 at a ceiling ratio of €5000 for an added treatment response, and to 0.85 at €10,000 per QALY gained. For avoiding new depressive episodes, blended CBT was deemed not cost-effective compared with standard CBT because the increase in costs was associated with negative effects. CONCLUSIONS: This pilot study shows that blended CBT might be a promising way to engage depressed patients in specialized mental health care. Compared with standard CBT, blended CBT was not considered cost-effective from a societal perspective but had an acceptable probability of being cost-effective from the health care provider perspective. Results should be carefully interpreted due to the small sample size. Further research in larger replication studies focused on optimizing the clinical effects of blended CBT and its budget impact is warranted. TRIAL REGISTRATION: Netherlands Trial Register NTR4650; https://www.trialregister.nl/trial/4408. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-014-0290-z.

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.

Embodied Conversational Agents in Clinical Psychology: A Scoping Review.

BACKGROUND: Embodied conversational agents (ECAs) are computer-generated characters that simulate key properties of human face-to-face conversation, such as verbal and nonverbal behavior. In Internet-based eHealth interventions, ECAs may be used for the delivery of automated human support factors. OBJECTIVE: We aim to provide an overview of the technological and clinical possibilities, as well as the evidence base for ECA applications in clinical psychology, to inform health professionals about the activity in this field of research. METHODS: Given the large variety of applied methodologies, types of applications, and scientific disciplines involved in ECA research, we conducted a systematic scoping review. Scoping reviews aim to map key concepts and types of evidence underlying an area of research, and answer less-specific questions than traditional systematic reviews. Systematic searches for ECA applications in the treatment of mood, anxiety, psychotic, autism spectrum, and substance use disorders were conducted in databases in the fields of psychology and computer science, as well as in interdisciplinary databases. Studies were included if they conveyed primary research findings on an ECA application that targeted one of the disorders. We mapped each study's background information, how the different disorders were addressed, how ECAs and users could interact with one another, methodological aspects, and the study's aims and outcomes. RESULTS: This study included N=54 publications (N=49 studies). More than half of the studies (n=26) focused on autism treatment, and ECAs were used most often for social skills training (n=23). Applications ranged from simple reinforcement of social behaviors through emotional expressions to sophisticated multimodal conversational systems. Most applications (n=43) were still in the development and piloting phase, that is, not yet ready for routine practice evaluation or application. Few studies conducted controlled research into clinical effects of ECAs, such as a reduction in symptom severity. CONCLUSIONS: ECAs for mental disorders are emerging. State-of-the-art techniques, involving, for example, communication through natural language or nonverbal behavior, are increasingly being considered and adopted for psychotherapeutic interventions in ECA research with promising results. However, evidence on their clinical application remains scarce. At present, their value to clinical practice lies mostly in the experimental determination of critical human support factors. In the context of using ECAs as an adjunct to existing interventions with the aim of supporting users, important questions remain with regard to the personalization of ECAs' interaction with users, and the optimal timing and manner of providing support. To increase the evidence base with regard to Internet interventions, we propose an additional focus on low-tech ECA solutions that can be rapidly developed, tested, and applied in routine practice.

Reactivity to smartphone-based ecological momentary assessment of depressive symptoms (MoodMonitor): protocol of a randomised controlled trial.

BACKGROUND: Ecological momentary assessment (EMA) of mental health symptoms may influence the symptoms that it measures, i.e. assessment reactivity. In the field of depression, EMA reactivity has received little attention. We aim to investigate whether EMA of depressive symptoms induces assessment reactivity. Reactivity will be operationalised as an effect of EMA on depressive symptoms measured by a retrospective questionnaire, and, secondly, as a change in response rate and variance of the EMA ratings. METHODS: This study is a 12-week randomised controlled trial comprising three groups: group 1 carries out EMA of mood and completes a retrospective questionnaire, group 2 carries out EMA of how energetic they feel and completes a retrospective questionnaire, group 3 is the control group, which completes only the retrospective questionnaire. The retrospective questionnaire (Centre for Epidemiologic Studies Depression scale; CES-D) assesses depressive symptoms and is administered at baseline, 6 weeks after baseline and 12 weeks after baseline. We aim to recruit 160 participants who experience mild to moderate depressive symptoms, defined as a Patient Health Questionnaire (PHQ-9) score of 5 to 15. This study is powered to detect a small between-groups effect, where no clinically relevant effect is defined as the effect size margin -0.25< d <0.25. DISCUSSION: To our knowledge, this is the first study to investigate whether self-rated EMA of depressive symptoms could induce assessment reactivity among mildly depressed individuals. TRIAL REGISTRATION: Netherlands Trial Register NTR5803. Registered 12 April 2016. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5803 .

Mobile Phone-Based Unobtrusive Ecological Momentary Assessment of Day-to-Day Mood: An Explorative Study.

BACKGROUND: Ecological momentary assessment (EMA) is a useful method to tap the dynamics of psychological and behavioral phenomena in real-world contexts. However, the response burden of (self-report) EMA limits its clinical utility. OBJECTIVE: The aim was to explore mobile phone-based unobtrusive EMA, in which mobile phone usage logs are considered as proxy measures of clinically relevant user states and contexts. METHODS: This was an uncontrolled explorative pilot study. Our study consisted of 6 weeks of EMA/unobtrusive EMA data collection in a Dutch student population (N=33), followed by a regression modeling analysis. Participants self-monitored their mood on their mobile phone (EMA) with a one-dimensional mood measure (1 to 10) and a two-dimensional circumplex measure (arousal/valence, -2 to 2). Meanwhile, with participants' consent, a mobile phone app unobtrusively collected (meta) data from six smartphone sensor logs (unobtrusive EMA: calls/short message service (SMS) text messages, screen time, application usage, accelerometer, and phone camera events). Through forward stepwise regression (FSR), we built personalized regression models from the unobtrusive EMA variables to predict day-to-day variation in EMA mood ratings. The predictive performance of these models (ie, cross-validated mean squared error and percentage of correct predictions) was compared to naive benchmark regression models (the mean model and a lag-2 history model). RESULTS: A total of 27 participants (81%) provided a mean 35.5 days (SD 3.8) of valid EMA/unobtrusive EMA data. The FSR models accurately predicted 55% to 76% of EMA mood scores. However, the predictive performance of these models was significantly inferior to that of naive benchmark models. CONCLUSIONS: Mobile phone-based unobtrusive EMA is a technically feasible and potentially powerful EMA variant. The method is young and positive findings may not replicate. At present, we do not recommend the application of FSR-based mood prediction in real-world clinical settings. Further psychometric studies and more advanced data mining techniques are needed to unlock unobtrusive EMA's true potential.

Web-based psychotherapy for posttraumatic stress disorder in war-traumatized Arab patients: randomized controlled trial.

BACKGROUND: In recent years, armed conflicts in the Middle East have resulted in high rates of exposure to traumatic events. Despite the increasing demand of mental health care provision, ongoing violence limits conventional approaches of mental health care provision. Internet-based interventions for posttraumatic stress disorder (PTSD) have proved feasible and effective in Western countries, but their applicability and efficacy in war and conflict regions remains unknown. OBJECTIVE: This study investigated the efficacy of a cognitive behavioral Internet-based intervention for war-traumatized Arab patients, with focus on Iraq. METHODS: A total of 159 individuals with PTSD participated in a parallel group randomized trial. Participants were randomly allocated by a computer-generated sequence to a treatment group (n=79) or a waiting list control group (n=80). The treatment group received 2 weekly 45-minute cognitive behavioral interventions via Internet over a 5-week period (10 sessions in total). The primary outcome was recovery from posttraumatic stress symptoms. RESULTS: Posttraumatic stress symptoms were significantly reduced from baseline to posttreatment (intention-to-treat analysis) in the treatment group relative to the control group (F1,157=44.29, P<.001, d=0.92). Treatment effects were sustained at 3-month follow-up. Completer analysis indicated that 29 of 47 patients (62%) in the treatment group had recovered from posttraumatic stress symptoms at posttreatment (reliable change and Posttraumatic Stress Diagnostic Scale score <20) versus 1 patient (2%) in the control group (OR 74.19, 95% CI 9.93-585.8, P<.001) indicating that the chance of recovering was 74.19 times higher in the treatment than in the control group. CONCLUSIONS: The results indicate, even in unstable and insecure settings with ongoing exposure to human rights violations through war and dictatorships, people with posttraumatic stress symptoms benefit from a cognitive behavioral treatment provided entirely through the Internet. This method of delivery could improve patients' access to humanitarian aid in the form of e-mental health services. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry, ACTRN12611001019998; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=347505 (Archived by WebCite at http://www.webcitation.org/6Wto4HCdH).

Blended vs. face-to-face cognitive behavioural treatment for major depression in specialized mental health care: study protocol of a randomized controlled cost-effectiveness trial.

BACKGROUND: Depression is a prevalent disorder, associated with a high disease burden and substantial societal, economic and personal costs. Cognitive behavioural treatment has been shown to provide adequate treatment for depression. By offering this treatment in a blended format, in which online and face-to-face treatment are combined, it might be possible to reduce the number of costly face-to-face sessions required to deliver the treatment protocol. This could improve the cost-effectiveness of treatment, while maintaining clinical effects. This protocol describes the design of a pilot study for the evaluation of the feasibility, acceptability and cost-effectiveness of blended cognitive behavioural therapy for patients with major depressive disorder in specialized outpatient mental health care. METHODS/DESIGN: In a randomized controlled trial design, adult patients with major depressive disorder are allocated to either blended cognitive behavioural treatment or traditional face-to-face cognitive behavioural treatment (treatment as usual). We aim to recruit one hundred and fifty patients. Blended treatment will consist of ten face-to-face and nine online sessions provided alternately on a weekly basis. Traditional cognitive behavioural treatment will consist of twenty weekly sessions. Costs and effects are measured at baseline and after 10, 20 and 30 weeks. Evaluations are directed at cost-effectiveness (with depression severity and diagnostic status as outcomes), and cost-utility (with costs per quality adjusted life year, QALY, as outcome). Costs will encompass health care uptake costs and productivity losses due to absence from work and lower levels of efficiency while at work. Other measures of interest are mastery, working alliance, treatment preference at baseline, depressive cognitions, treatment satisfaction and system usability. DISCUSSION: The results of this pilot study will provide an initial insight into the feasibility and acceptability of blended cognitive behavioural treatment in terms of clinical and economic outcomes (proof of concept) in routine specialized mental health care settings, and an indication as to whether a well-powered clinical trial of blended cognitive behavioural treatment for depression in routine practice would be advisable. This will be determined based on the perspective of various stakeholders including patients, mental health service providers and health insurers. Strengths and limitations of the study are discussed. TRIAL REGISTRATION: Netherlands Trial Register NTR4650 . Registered 18 June 2014.

The relationship between acculturation strategies and depressive and anxiety disorders in Turkish migrants in the Netherlands.

BACKGROUND: Turkish migrants in the Netherlands have a high prevalence of depressive and/or anxiety disorders. Acculturation has been shown to be related to higher levels of psychological distress, although it is not clear whether this also holds for depressive and anxiety disorders in Turkish migrants. This study aims to clarify the relationship between acculturation strategies (integration, assimilation, separation and marginalization) and the prevalence of depressive and anxiety disorders as well as utilisation of GP care among Turkish migrants. METHODS: Existing data from an epidemiological study conducted among Dutch, Turkish and Moroccan inhabitants of Amsterdam were re-examined. Four scales of acculturation strategies were created in combination with the bi-dimensional approach of acculturation by factor analysis. The Lowlands Acculturation Scale and the Composite International Diagnostic Interview were used to assess acculturation and mood and anxiety disorders. Socio-demographic variables, depressive, anxiety and co-morbidity of both disorders and the use of health care services were associated with the four acculturation strategies by means of Chi-Squared and Likelihood tests. Three two-step logistic regression analyses were performed to control for possible, confounding variables. RESULTS: The sample consisted of 210 Turkish migrants. Significant associations were found between the acculturation strategies and age (p < .01), education (p < .01), daily occupation (p < .01) and having a long-term relationship (p = .03). A significant association was found between acculturation strategies and depressive disorders (p = .049): integration was associated with a lower risk of depression, separation with a higher risk. Using the axis separately, participation in Dutch society showed a significant relationship with a decreased risk of depressive, anxiety and co-morbidity of both disorders (OR = .15; 95% CI: .024 - .98). Non-participation showed no significant association. No association was found between the acculturation strategies and uptake of GP care. CONCLUSIONS: Turkish migrants who integrate may have a lower risk of developing a depressive disorder. Participation in Dutch culture is associated with a decreased risk of depressive, anxiety and co-morbidity of both disorders. Further research should focus on the assessment of acculturation in the detection of depression.

Online cognitive-behavioural treatment of bulimic symptoms: a randomized controlled trial.

BACKGROUND: Manualized cognitive-behavioural treatment (CBT) is underutilized in the treatment of bulimic symptoms. Internet-delivered treatment may reduce current barriers. OBJECTIVE: This study aimed to assess the efficacy of a new online CBT of bulimic symptoms. METHOD: Participants with bulimic symptoms (n = 105) were randomly allocated to online CBT, bibliotherapy or waiting list/delayed treatment condition. Data were gathered at pre-treatment, post-treatment and 1-year follow-up. OUTCOME MEASURES: The primary outcome measures were the Eating Disorder Examination Questionnaire (EDE-Q) and the frequency of binge eating and purging episodes. The secondary outcome measure was the Body Attitude Test. RESULTS: Dropout from Internet treatment was 26%. Intention-to-treat ANCOVAs of post-test data revealed that the EDE-Q scores and the frequency of binging and purging reduced more in the online CBT group compared with the bibliotherapy and waiting list groups (pooled between-group effect size: d = 0.9). At 1-year follow-up, improvements in the online CBT group had sustained. CONCLUSION: This study identifies online CBT as a viable alternative in the treatment of bulimic symptoms.

Efficacy and effectiveness of online cognitive behavioral treatment: a decade of interapy research.

Since 1996, researchers of the Interapy research group of the University of Amsterdam have been examining the effects of online cognitive behavioral treatment (online CBT). Over the years, the group conducted nine controlled trials of online CBT for a variety of mental health disorders, among a total of 840 participants. These studies suggest that online CBT is a viable and effective alternative to face-to-face treatment. Treatment adherence was 82%, and reductions in psychopathology represented a large between-group effect size of SMD = 0.9 (95% CI: .7 to 1.1), which was maintained over long periods. The research culminated in the foundation of the Interapy clinic, which received Dutch health regulatory body approval in 2005. Since then, costs of online CBT are reimbursed through public health insurance. A large study of the treatment outcome of 1,500 patients of the Interapy clinic showed that effects in clinical practice are similar to those observed in the controlled trials, and comparable to selected benchmarks of naturalistic studies of face-to-face CBT. The accumulated evidence provides compelling support for the efficacy and effectiveness of online CBT.

Increasing demand for school counselling through a lay counsellor-delivered classroom sensitisation intervention: a stepped-wedge cluster randomised controlled trial in New Delhi, India.

INTRODUCTION: We evaluated a classroom-based sensitisation intervention that was designed to reduce demand-side barriers affecting referrals to a school counselling programme. The sensitisation intervention was offered in the context of a host trial evaluating a low-intensity problem-solving treatment for common adolescent mental health problems. METHODS: We conducted a stepped-wedge, cluster randomised controlled trial with 70 classes in 6 secondary schools serving low-income communities in New Delhi, India.The classes were randomised to receive a classroom sensitisation session involving a brief video presentation and moderated group discussion, delivered by a lay counsellor over one class period (intervention condition, IC), in two steps of 4 weeks each. The control condition (CC) was whole-school sensitisation (teacher-meetings and whole-school activities such as poster displays). The primary outcome was the proportion of students referred into the host trial. Secondary outcomes were the proportion of students who met mental health caseness criteria and the proportion of self-referred adolescents. RESULTS: Between 20 August 2018 and 9 December 2018, 835 students (23.3% of all students) were referred into the host trial. The referred sample included 591 boys (70.8%), and had a mean age of 15.8 years, SD=0.06; 194 students (31.8% of 610 with complete data) met mental health caseness criteria. The proportion of students referred in each trial conditionwas significantly higher in the IC (IC=21.7%, CC=1.5%, OR=111.36, 95% CI 35.56 to 348.77, p<0.001). The proportion of self-referred participants was also higher in the IC (IC=98.1%, CC=89.1%, Pearson χ2 (1)=16.92, p<0.001). Although the proportion of referred students meeting caseness criteria was similar in both conditions (IC=32.0% vs CC=28.1%), the proportion weighted for the total student population was substantially higher in the IC (IC=5.2%, CC=0.3%, OR=52.39, 95% CI 12.49 to 219.66,p<0.001). CONCLUSION: A single, lay counsellor-delivered, classroom sensitisation session increased psychological help-seeking for common mental health problems among secondary school pupils from urban, low-income communities in India. TRIAL REGISTRATION NUMBER: NCT03633916.

Ethical dilemmas in online research and treatment of sexually abused adolescents.

BACKGROUND: In a recent uncontrolled trial of a new therapist-assisted Web-based treatment of adolescent victims of sexual abuse, the treatment effects were found to be promising. However, the study suffered a large pretreatment withdrawal rate that appeared to emanate from reluctance among the participants to disclose their identity and obtain their parents' consent. OBJECTIVE: Our objectives were to confirm the effects of the online treatment in a controlled trial and to evaluate measures to reduce pretreatment withdrawal in vulnerable populations including young victims of sexual abuse. METHODS: The study was designed as a within-subject baseline-controlled trial. Effects of an 8-week attention-placebo intervention were contrasted with the effects of an 8-week treatment episode. Several measures were taken to reduce pretreatment dropout. RESULTS: Pretreatment withdrawal was reduced but remained high (82/106, 77%). On the other hand, treatment dropout was low (4 out of 24 participants), and improvement during treatment showed significantly higher effects than during the attention placebo control period (net effect sizes between 0.5 and 1.6). CONCLUSIONS: In treatment of vulnerable young populations, caregivers and researchers will have to come to terms with high pretreatment withdrawal rates. Possible measures may reduce pretreatment withdrawal to some degree. Providing full anonymity is not a viable option since it is incompatible with the professional responsibility of the caregiver and restricts research possibilities.

Working Alliance in Blended Versus Face-to-Face Cognitive Behavioral Treatment for Patients with Depression in Specialized Mental Health Care.

This study investigates working alliance in blended cognitive behavioral therapy (bCBT) for depressed adults in specialized mental health care. Patients were randomly allocated to bCBT (n = 47) or face-to-face CBT (n = 45). After 10 weeks of treatment, both patients and therapists in the two groups rated the therapeutic alliance on the Working Alliance Inventory Short-Form Revised (WAI-SR; Task, Bond, Goal, and composite scores). No between-group differences were found in relation to either patient or therapist alliance ratings, which were high in both groups. In the full sample, a moderate positive association was found between patient and therapist ratings on Task (ρ = 0.41, 95% CI 0.20; 0.59), but no significant associations emerged on other components or composite scores. At 30 weeks, within-and between-group associations between alliance and changes in depression severity (QIDS, Quick Inventory of Depressive Symptomatology) were analyzed with linear mixed models. The analyses revealed an association between depression over time, patient-rated alliance, and group (p < 0.001). In face-to-face CBT, but not in bCBT, lower depression scores were associated with higher alliance ratings. The online component in bCBT may have led patients to evaluate the working alliance differently from patients receiving face-to-face CBT only.

Improving adherence to an online intervention for low mood with a virtual coach: study protocol of a pilot randomized controlled trial.

BACKGROUND: Internet-based cognitive-behavioral therapy (iCBT) is more effective when it is guided by human support than when it is unguided. This may be attributable to higher adherence rates that result from a positive effect of the accompanying support on motivation and on engagement with the intervention. This protocol presents the design of a pilot randomized controlled trial that aims to start bridging the gap between guided and unguided interventions. It will test an intervention that includes automated support delivered by an embodied conversational agent (ECA) in the form of a virtual coach. METHODS/DESIGN: The study will employ a pilot two-armed randomized controlled trial design. The primary outcomes of the trial will be (1) the effectiveness of iCBT, as supported by a virtual coach, in terms of improved intervention adherence in comparison with unguided iCBT, and (2) the feasibility of a future, larger-scale trial in terms of recruitment, acceptability, and sample size calculation. Secondary aims will be to assess the virtual coach's effect on motivation, users' perceptions of the virtual coach, and general feasibility of the intervention as supported by a virtual coach. We will recruit N = 70 participants from the general population who wish to learn how they can improve their mood by using Moodbuster Lite, a 4-week cognitive-behavioral therapy course. Candidates with symptoms of moderate to severe depression will be excluded from study participation. Included participants will be randomized in a 1:1 ratio to either (1) Moodbuster Lite with automated support delivered by a virtual coach or (2) Moodbuster Lite without automated support. Assessments will be taken at baseline and post-study 4 weeks later. DISCUSSION: The study will assess the preliminary effectiveness of a virtual coach in improving adherence and will determine the feasibility of a larger-scale RCT. It could represent a significant step in bridging the gap between guided and unguided iCBT interventions. TRIAL REGISTRATION: Netherlands Trial Register (NTR) NL8110 . Registered on 23 October 2019.

Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trial.

BACKGROUND: Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. However, the use of these interventions in routine care is limited. The international ImpleMentAll study is funded by the European Union's Horizon 2020 programme. It is concerned with studying and improving methods for implementing evidence-based iCBT services for common mental disorders in routine mental health care. A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts. This study investigates the effectiveness of the ItFits-toolkit by comparing it to implementation-as-usual activities. METHODS: A stepped wedge cluster randomized controlled trial (SWT) design will be applied. Over a trial period of 30 months, the ItFits-toolkit will be introduced sequentially in twelve routine mental health care organizations in primary and specialist care across nine countries in Europe and Australia. Repeated measures are applied to assess change over time in the outcome variables. The effectiveness of the ItFits-toolkit will be assessed in terms of the degree of normalization of the use of the iCBT services. Several exploratory outcomes including uptake of the iCBT services will be measured to feed the interpretation of the primary outcome. Data will be collected via a centralized data collection system and analysed using generalized linear mixed modelling. A qualitative process evaluation of routine implementation activities and the use of the ItFits-toolkit will be conducted within this study. DISCUSSION: The ImpleMentAll study is a large-scale international research project designed to study the effectiveness of tailored implementation. Using a SWT design that allows to examine change over time, this study will investigate the effect of tailored implementation on the normalization of the use of iCBT services and their uptake. It will provide a better understanding of the process and methods of tailoring implementation strategies. If found effective, the ItFits-toolkit will be made accessible for mental health care service providers, to help them overcome their context-specific implementation challenges. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883 . Retrospectively registered on 29 August 2018.

Standardized web-based cognitive behavioural therapy of mild to moderate depression: a randomized controlled trial with a long-term follow-up.

Depression is common but undertreated. Web-based self-help provides a widely accessible treatment alternative for mild to moderate depression. However, the lack of therapist guidance may limit its efficacy. The authors assess the efficacy of therapist-guided web-based cognitive behavioural treatment (web-CBT) of mild to moderate depression. Fifty-four individuals with chronic, moderate depression participated in a randomized wait-list controlled trial, with an 18-month follow-up (immediate treatment: n = 36, wait-list control: n = 18). Primary outcome measures were the Beck Depression Inventory (BDI-IA) and the Depression scale of the Symptom Checklist-90-Revised (SCL-90-R. DEP). Secondary outcome measures were the Depression Anxiety Stress Scales and the Well-Being Questionnaire. Five participants (9%) dropped out. Intention-to-treat analyses of covariance revealed that participants in the treatment condition improved significantly more than those in the wait-list control condition (.011 < p < .015). With regard to the primary measures, between-group effects (d) were 0.7 for the BDI-IA and 1.1 for the SCL-90-R DEP. Posttest SCL-90- R DEP scores indicated recovery of 49% of the participants in the treatment group compared with 6% in the control group (odds ratio = 14.5; p < .004). On average, the effects were stable up to 18 months (n = 39), although medication was a strong predictor of relapse. The results demonstrate the efficacy of web-CBT for mild to moderate depression and the importance of therapist guidance in psychological interventions.

Validating Automated Sentiment Analysis of Online Cognitive Behavioral Therapy Patient Texts: An Exploratory Study.

INTRODUCTION: Sentiment analysis may be a useful technique to derive a user's emotional state from free text input, allowing for more empathic automated feedback in online cognitive behavioral therapy (iCBT) interventions for psychological disorders such as depression. As guided iCBT is considered more effective than unguided iCBT, such automated feedback may help close the gap between the two. The accuracy of automated sentiment analysis is domain dependent, and it is unclear how well the technology is applicable to iCBT. This paper presents an empirical study in which automated sentiment analysis by an algorithm for the Dutch language is validated against human judgment. METHODS: A total of 493 iCBT user texts were evaluated on overall sentiment and the presence of five specific emotions by an algorithm, and by 52 psychology students who evaluated 75 randomly selected texts each, providing about eight human evaluations per text. Inter-rater agreement (IRR) between algorithm and humans, and humans among each other, was analyzed by calculating the intra-class correlation under a numerical interpretation of the data, and Cohen's kappa, and Krippendorff's alpha under a categorical interpretation. RESULTS: All analyses indicated moderate agreement between the algorithm and average human judgment with respect to evaluating overall sentiment, and low agreement for the specific emotions. Somewhat surprisingly, the same was the case for the IRR among human judges, which means that the algorithm performed about as well as a randomly selected human judge. Thus, considering average human judgment as a benchmark for the applicability of automated sentiment analysis, the technique can be considered for practical application. DISCUSSION/CONCLUSION: The low human-human agreement on the presence of emotions may be due to the nature of the texts, it may simply be difficult for humans to agree on the presence of the selected emotions, or perhaps trained therapists would have reached more consensus. Future research may focus on validating the algorithm against a more solid benchmark, on applying the algorithm in an application in which empathic feedback is provided, for example, by an embodied conversational agent, or on improving the algorithm for the iCBT domain with a bottom-up machine learning approach.

Unraveling the Black Box: Exploring Usage Patterns of a Blended Treatment for Depression in a Multicenter Study.

BACKGROUND: Blended treatments, combining digital components with face-to-face (FTF) therapy, are starting to find their way into mental health care. Knowledge on how blended treatments should be set up is, however, still limited. To further explore and optimize blended treatment protocols, it is important to obtain a full picture of what actually happens during treatments when applied in routine mental health care. OBJECTIVE: The aims of this study were to gain insight into the usage of the different components of a blended cognitive behavioral therapy (bCBT) for depression and reflect on actual engagement as compared with intended application, compare bCBT usage between primary and specialized care, and explore different usage patterns. METHODS: Data used were collected from participants of the European Comparative Effectiveness Research on Internet-Based Depression Treatment project, a European multisite randomized controlled trial comparing bCBT with regular care for depression. Patients were recruited in primary and specialized routine mental health care settings between February 2015 and December 2017. Analyses were performed on the group of participants allocated to the bCBT condition who made use of the Moodbuster platform and for whom data from all blended components were available (n=200). Included patients were from Germany, Poland, the Netherlands, and France; 64.5% (129/200) were female and the average age was 42 years (range 18-74 years). RESULTS: Overall, there was a large variability in the usage of the blended treatment. A clear distinction between care settings was observed, with longer treatment duration and more FTF sessions in specialized care and a more active and intensive usage of the Web-based component by the patients in primary care. Of the patients who started the bCBT, 89.5% (179/200) also continued with this treatment format. Treatment preference, educational level, and the number of comorbid disorders were associated with bCBT engagement. CONCLUSIONS: Blended treatments can be applied to a group of patients being treated for depression in routine mental health care. Rather than striving for an optimal blend, a more personalized blended care approach seems to be the most suitable. The next step is to gain more insight into the clinical and cost-effectiveness of blended treatments and to further facilitate uptake in routine mental health care.

The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial.

BACKGROUND: Conduct, anxiety, and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention for school-going adolescents with common mental health problems in India. The protocol also tests the effects of a classroom-based sensitization intervention on the demand for counselling services in an embedded recruitment trial. METHODS/DESIGN: We will conduct a two-arm, individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9-12 with persistent, elevated mental health symptoms and associated distress/impairment. Participants will receive either a brief problem-solving intervention delivered over 3 weeks by lay counsellors (intervention) or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health symptoms and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported distress/impairment, perceived stress, mental wellbeing, and clinical remission, as well as parent-reported adolescent mental health symptoms and impact scores, will be assessed at 6 and 12 weeks post-randomization. We will also complete a parallel process evaluation, including estimations of the costs of delivering the interventions. An embedded recruitment trial will apply a stepped-wedge, cluster (class)-randomized controlled design in 70 classes across the six schools. This will evaluate the added effect of a classroom-based sensitization intervention over and above school-level sensitization activities on the primary outcome of referral rate into the host trial. Other outcomes will be the proportion of referrals eligible to participate in the host trial, proportion of self-generated referrals, and severity and pattern of symptoms among referred adolescents in each condition. Power calculations were undertaken separately for each trial. A detailed statistical analysis plan will be developed separately for each trial prior to unblinding. DISCUSSION: Both trials were initiated on 20 August 2018. A single research protocol for both trials offers a resource-efficient methodology for testing the effectiveness of linked procedures to enhance uptake and outcomes of a school-based psychological intervention for common adolescent mental health problems. TRIAL REGISTRATION: Both trials are registered prospectively with the National Institute of Health registry ( www.clinicaltrials.gov ), registration numbers NCT03633916 and NCT03630471 , registered on 16th August, 2018 and 14th August, 2018 respectively).