Evaluation of the internet-based intervention "Selfapy" in participants with unipolar depression and the impact on quality of life: a randomized, parallel group study.

PURPOSE: Depressive disorders cause a major burden of disease worldwide and often lead to a loss of social functioning. Patients suffering from depressive disorders report a lower quality of life (QOL) than people without a history of mental health issues. Internet-based interventions (IBIs) based on cognitive behavioral therapy (CBT) are effective in reducing symptom severity but data on their impact on quality of life in clinically depressed patients so far is scarce. METHODS: Selfapy is a CBT-based IBI for depressive disorders. 401 participants (332 female, mean age 37 (SD = 11) with a diagnosis of major depressive disorder (MDD) or dysthymia were enrolled in a randomized, parallel, three-arm trial comparing a therapist-guided Selfapy intervention with an unguided Selfapy intervention and a waiting list control. QOL was measured using the WHOQOL-BREF at baseline, post-treatment (12 weeks) and at 24-week follow-up. The effects of the interventions on QOL were calculated using linear mixed effects models. RESULTS: At post-treatment (12 weeks) the guided and unguided intervention groups reported an increase in QOL on physical and psychological health domains compared to controls (significant group*time interaction). The gain in QOL was maintained over the follow-up period only for psychological health. QOL decreased in the social relationships and environment domains over the course of treatment and during the follow-up treatment for all participants. There were no differences between the guided and the unguided intervention. CONCLUSION: Selfapy proved to positively affect psychological and physical QOL in a sample of participants suffering from depressive disorders and can therefore be considered an effective and highly scalable therapeutic tool. The pattern of results might partly be attributable to effects of the COVID-19 pandemic and public health measures that coincided with the trial. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00017191. Registered June 14th, 2019, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017191 .

Working alliance and its link to guidance in an internet-based intervention for depressive disorders: a secondary analysis of a randomized controlled trial.

Background: Guided Internet-based interventions (IBIs) are typically found to be more effective than unguided ones, but the reasons behind this are not well understood. The therapist-client working alliance, crucial in face-to-face psychotherapy, is also increasingly recognized as an important factor in IBIs. This study examines trajectories of the working alliance and its relationship to therapeutic guidance through a secondary analysis of a randomized controlled trial (RCT) on Selfapy, a 12-week IBI based on cognitive behavioral therapy for depressive disorders. The trial compared a therapist-guided version (with weekly calls) to an unguided version (n = 301, mean age 37 years, 83% female, mean BDI-II = 30.09). Methods: Based on an intention-to-treat approach, this study investigates within- and between-group differences in the quality of the working alliance, assessed with the WAI-SR questionnaire at mid- and post-treatment via repeated measures ANOVA. Furthermore, correlations and mediation analyses were conducted to explore the relationship between the working alliance and outcomes, as well as adherence parameters. Results: Findings indicate that the IBI was successful in fostering a robust working alliance in both intervention groups, with similar ratings at mid-treatment but significantly higher ratings in the guided group at post-treatment (Cohen's d = -0.38). Post-treatment working alliance scores were positively linked to symptom reduction at post-treatment (guided: r = .25, unguided r = .15) and follow-up (guided: r = .25, unguided: r = .17). In the unguided group, the association was primarily driven by the subscale task. Serial mediation analysis indicated that the relationship between guidance and outcomes at follow-up was mediated by working alliance (b = 0.59; 95% CI: 0.14, 1.22) and a link between working alliance and adherence (b = 0.15; 95% CI: 0.04, 0.34). Conclusions: Considering limitations like using a questionnaire developed for face-to-face therapy, findings support the importance of the working alliance in guided IBIs, while also providing new insights into its role and formation in unguided IBIs. The potential benefits of a strong working alliance, notably by improving adherence, may prove crucial for integrating guided as well as unguided IBIs into routine use, indicating the need for additional research in this context. Clinical Trial Registration: https://tinyurl.com/2p9h5hnx, German Clinical Trials Register DRKS00017191.

Efficacy and acceptability of third-wave psychotherapies in the treatment of depression: a network meta-analysis of controlled trials.

Introduction: In recent decades, various new psychotherapy approaches have been developed in an effort to overcome issues of non-response, referred to as "third-wave psychotherapies." How third-wave therapies perform in comparison to each other, to classical CBT, or other common comparators in the treatment of depression has not yet been systematically assessed. Methods: We firstly determined the scope of the term "third-wave" by conducting a systematic search. The identified approaches were then used as search terms for the systematic review and network meta-analysis (NMA). We searched MEDLINE, CENTRAL, PsychINFO and Web of Science from inception until 31 July 2022. We assessed randomized controlled trials comparing third-wave psychotherapies to each other, CBT, treatment as usual (TAU), medication management, active control conditions, or waitlist (WL) in adult populations with depressive disorders. The treatments included were acceptance and commitment therapy, behavioral activation, cognitive behavioral analysis system of psychotherapy, dialectical behavioral therapy, mindfulness-based cognitive therapy, meta-cognitive therapy, positive psychotherapy and schema therapy. The primary outcome was depression severity (efficacy) at study endpoint, and the secondary outcome was all-cause discontinuation (acceptability). This review was registered in PROSPERO, identifier CRD42020147535. Results: Of 7,971 search results, 55 trials were included in our NMA (5,827 patients). None of the third-wave therapies were more efficacious than CBT but most were superior to TAU [standardized mean differences (SMD) ranging between 0.42 (95% CI -0.37; 1.19) and 1.25 (0.48; 2.04)]. Meta-cognitive therapy (MCT) was more efficacious than three other third-wave therapy approaches. None of the third-wave treatments were more acceptable than WL or CBT. Twenty-seven percent of the trials were rated as low risk of bias. Confidence in the evidence was largely low according to GRADE. Inconsistency emerged for a small number of comparisons. Interpretations: Third-wave therapies are largely efficacious and acceptable alternatives to CBT when compared to TAU, with few differences between them. The evidence so far does not point toward superiority or inferiority over CBT. Patient-level research may offer possibilities for tailoring individual psychotherapies to the needs of individual patients and future trials should make this data available. The evidence base needs to be broadened by sufficiently powered trials.

Efficacy of adding nutritional supplements in unipolar depression: A systematic review and meta-analysis.

In this article, we aimed to assess the efficacy of adjunctive administration of nutritional supplements to antidepressants by means of a systematic review and meta-analysis. The supplements included were inositol, vitamin D, folic acid, vitamin B12, S-adenosyl-L-methionine (SAMe), omega-3 polyunsaturated fatty acids (n-3 PUFA) and zinc. A structured database search (MEDLINE, EBSCO, CENTRAL, Web of Science) was performed using terms for the respective substances in conjunction with terms for depression and the mode of treatment ("add-on" OR "adjunctive" OR "augmentation"). Meta-analyses, randomized controlled trials (RCTs) and non-randomized comparative studies that investigated the supplements as an add-on in the treatment of clinically diagnosed MDD were included. Agents had to be added to an existing antidepressant regime (augmentation) or started simultaneously with the antidepressant (acceleration). For n-3 PUFAs, folic acid and zinc, new meta-analyses were performed as part of this work. Our meta-analyses of 10 articles on n-3 PUFAs and four on zinc support their efficacy. For folic acid, our meta-analysis does not support efficacy. For n-3 PUFAs, sensitivity analysis showed no difference between acceleration and augmentation designs, but significant differences between individuals with or without comorbidities. For the remaining substances, only a few RCTs were available. The preliminary data on inositol was negative, while one RCT for vitamin D demonstrated positive results. For vitamin B12 one and for SAMe two RCTs and a few open trials are available reporting positive and mixed results. To summarize, for most of the substances, the available data is not yet sufficient or inconclusive.