RESUMEN
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.
Asunto(s)
Terapia Cognitivo-Conductual , Humanos , Terapia Cognitivo-Conductual/métodos , Femenino , Masculino , Adulto , Europa (Continente) , Persona de Mediana Edad , Depresión/terapia , Trastorno Depresivo Mayor/terapia , Alianza Terapéutica , Análisis de Datos SecundariosRESUMEN
OBJECTIVE: Migration is a profound life transition that may threaten migrants' well-being and mental health. Results of several studies suggest that social self-efficacy beliefs may be beneficial for the psychological adjustment of migrants, buffering the effect of specific stressors related to migration, helping them reduce anxiety levels, and providing support in forming of new social bonds and better integration with a new community or culture. The primary purpose of this randomized controlled trial was to examine the effectiveness of the New in Town internet-based self-efficacy intervention for internal migrants in Poland. METHODS: Participants were 158 internal adult migrants who had changed residence in the last 6 months. They were randomized into two groups: an experimental group (receiving an internet-based self-efficacy intervention), and a waiting list control group. We examined if the intervention was effective in enhancing participants' social self-efficacy (primary outcome), general self-efficacy, social support, satisfaction with life, and reduced reported loneliness (secondary outcomes). Outcome measures were assessed at baseline (Time 1) and 3-weeks later (Time 2). The dropout rate was 50.6%. Initially, we planned to gather follow-up data also 8-weeks after baseline (Time 3). However, due to health and safety reasons related to the COVID-19 pandemic, we decided to stop the trial. Finally, we included in our analysis only data gathered before the COVID-19 pandemic at Time 1 and Time 2. RESULTS: A total of 159 individuals who met the study's inclusion criteria and completed the baseline assessment were randomly assigned to either the experimental group (n = 80) or the waiting list control group (n = 79). Nevertheless, one participant assigned to the control group was excluded from the analyses because they withdrew their consent to participate after being randomized. The study results suggest that compared to the waitlist control group (n = 78), participants in the experimental group (n = 80) reported a higher level of general self-efficacy beliefs at Time 2 (Cohen's d = 0.47; 95% CI: 0.15-0.79). However, there were no statistically significant effects on social self-efficacy, social support, satisfaction with life, and loneliness. CONCLUSION: The study offers preliminary support for the effectiveness of an internet-based self-efficacy intervention designed for internal migrants on general self-efficacy beliefs. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov (identifier: NCT04088487) on 11th September 2019.