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.

What to do when the unwanted happens? Negative event management in studies on internet- and mobile-based interventions for youths and adults with two case reports.

Background: Despite severely burdened individuals, often being excluded from research studies on internet- and mobile-based interventions (IMIs), negative events (NEs) including suicidal thoughts and behaviors (STBs) can still occur during a trial. NEs require monitoring and adequate safety measures. However, study protocols frequently lack comprehensive descriptions of procedures for managing NEs. Aims: This study aimed to illustrate the assessment, monitoring, and procedures for addressing NEs in two studies on IMIs in adults and youth using case reports, to identify strengths and weaknesses of the NE management approaches, and to derive key learnings and recommendations. Methods: Two case reports were drawn from two distinct IMI studies. The first study, PSYCHOnlineTHERAPY, evaluates the combination of an IMI with on-site psychotherapy for anxiety and depressive disorders in adults (adult blended study). The second study evaluates a standalone, therapist-guided IMI for post-traumatic stress disorder (PTSD) in youth (youth standalone study). Potential NEs were predefined depending on the study sample. The case studies thoroughly document the systematic recording and ongoing monitoring of NEs through self-report and observer-based assessments during the interventions. The cases illustrate a variety of NE management strategies, including automated and personalized approaches, adapted to the specific nature and severity of the NEs. The NE management approaches are visualized using decision trees. Results: In the adult blended case study, online questionnaires detected STBs and triggered automated support information. As on-site therapy had already ended, a telephone consultation session allowed for the identification and discussion of the heightened intensity of suicidal thoughts, along with the development of specific additional help options. In the youth standalone case study, heightened tension in an adolescent with PTSD during trauma processing could be addressed in a telephone therapeutic session focusing on resource activation and emotion regulation. The referral to on-site treatment was supported. Overall, advantages of the NE management included automated procedures, multimodal assessment of a wide range of NEs, and standardized procedures tailored to different severity levels. Weaknesses included the use of single-item assessments for STBs and lack of procedures in case of deterioration or nonresponse to treatment. Conclusion: This study provides practical insights and derives key learnings and recommendations regarding the management of NEs in different IMI contexts for both adults and youth.