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 .

[Efficacy of internet-based interventions for depression available in Germany-A systematic review and meta-analysis]. / Wirksamkeit in Deutschland verfügbarer internetbasierter Interventionen für Depressionen ­ ein systematisches Review mit Metaanalyse.

BACKGROUND: Internet-based interventions (IBIs) for the treatment of depression have been found to have positive effects in international meta-analyses; however, it is unclear whether these effects also extend to IBIs specifically available in Germany. The aim of this meta-analysis was to estimate the immediate effects and the long-term effects of IBIs available in Germany free of charge or available on prescription and covered by the public health insurances as so-called digital health applications (DiGAs) and to compare the efficacy of DiGAs and freely available IBIs. METHOD: A systematic literature search and random-effects meta-analysis were performed (preregistration: INPLASY202250070). Randomized controlled trials (RCTs) of IBIs freely available in Germany or as DiGA in adults with elevated depressive symptoms were compared with active and inactive controls available at the time of the survey in May 2022. RESULTS: A total of six interventions were identified: COGITO, deprexis, iFightDepression, moodgym, Novego, and Selfapy. The pooled effect size of a total of 28 studies with 13,413 participants corresponded to an effect of Cohen's d = 0.42, (95% confidence interval, CI: 0.31-0.54, I2 = 81%). The analysis of long-term effects showed a smaller effect size of d = 0.29, (95% CI: 0.21-0.37, I2 = 22%, N = 10). Subgroup analyses indicated a possible superiority of the three interventions listed in the DiGA directory (d = 0.56, 95% CI: 0.38-0.74, I2 = 83%, N = 15) compared to the three freely available IBIs (d = 0.24, 95% CI: 0.14-0.33, I2 = 44%, N = 13, p = 0.002). CONCLUSION: The IBIs for depressive disorders available in Germany are effective and can therefore be used in the treatment of people with a depressive disorder; however, it is possible that not all interventions are equally effective.

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.

Peripheral oxytocin levels are linked to hypothalamic gray matter volume in autistic adults: a cross-sectional secondary data analysis.

Oxytocin (OXT) is known to modulate social behavior and cognition and has been discussed as pathophysiological and therapeutic factor for autism spectrum disorder (ASD). An accumulating body of evidence indicates the hypothalamus to be of particular importance with regard to the underlying neurobiology. Here we used a region of interest voxel-based morphometry (VBM) approach to investigate hypothalamic gray matter volume (GMV) in autistic (n = 29, age 36.03 ± 11.0) and non-autistic adults (n = 27, age 30.96 ± 11.2). Peripheral plasma OXT levels and the autism spectrum quotient (AQ) were used for correlation analyses. Results showed no differences in hypothalamic GMV in autistic compared to non-autistic adults but suggested a differential association between hypothalamic GMV and OXT levels, such that a positive association was found for the ASD group. In addition, hypothalamic GMV showed a positive association with autistic traits in the ASD group. Bearing in mind the limitations such as a relatively small sample size, a wide age range and a high rate of psychopharmacological treatment in the ASD sample, these results provide new preliminary evidence for a potentially important role of the HTH in ASD and its relationship to the OXT system, but also point towards the importance of interindividual differences.