NCT06738953 Prevention of Mental Disorders Through Self-efficacy Interventions
| NCT ID | NCT06738953 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Health and Medical University Potsdam |
| Condition | Depression Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 378 participants |
| Start Date | 2024-11-18 |
| Primary Completion | 2026-04-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 378 participants in total. It began in 2024-11-18 with a primary completion date of 2026-04-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Low self-efficacy is a transdiagnostic risk factor for several mental disorders. Self-efficacy refers to one's belief that one is capable of performing a behavior necessary to successfully complete a task or achieve a goal. Consistent with theoretical models and empirical findings, individuals with low self-efficacy are more likely to perceive challenges as uncontrollable and threatening and thus are at increased risk for developing mental disorders during sensitive periods such as young adulthood. Self-efficacy interventions have been shown to be effective in promoting health behavior change, quality of life, and treatment adherence in patients with serious illnesses, as well as motivation and performance in students and employees. However, whether targeted self-efficacy training can prospectively prevent the onset of full-threshold anxiety, affective, and substance use disorders in young adults at increased risk for psychopathology remains an open question. The aim of this randomized controlled trial is to test whether a brief cognitive-behavioral intervention in young adults with low self-efficacy can increase general self-efficacy (primary outcome of intervention effectiveness) and thus prevent the onset of DSM-5 mental disorders in the subsequent year (primary outcome of prevention effectiveness). In addition, we examine whether improvements in domain-specific self-efficacy lead to subsequent improvements in general self-efficacy and thus to lower psychopathological symptoms (spillover effects). Young adults (18-30 years) with low self-efficacy but no mental disorder will be included (N=378). The study will include screening, entry, baseline, post, and 12-month follow-up assessments plus additional course assessments in both groups. After the baseline assessment, participants will be randomized to an intervention or control group. The intervention group will receive group-based self-efficacy training (6 sessions of 75-90 minutes each). The control group will also meet in groups (6 sessions) but will only talk about psychological research findings unrelated to self-efficacy or cognitive-behavioral interventions without receiving any training. DSM-5 mental disorders will be assessed at study entry and follow-up with a structured diagnostic interview. Other outcomes will be assessed with established scales and ecological momentary assessments (EMA) at baseline, post and follow-up. Clinical outcomes include psychopathological symptoms (dimensional scores for anxiety, depression, anger, and somatic symptoms, as well as sleep disturbance) and mental disorders (DSM-5 categorical diagnoses of anxiety, affective, and substance use disorders). Intervention effectiveness will be tested using logistic/linear regression and multilevel analyses. Spillover effects between improvements in domain-specific/general self-efficacy and psychopathological symptoms over the course of the study will be examined using cross-lagged panel models.
Eligibility Criteria
Inclusion Criteria: 1. age 18-30 years and 2. low scores (≤24) on the German version of the General Self-Efficacy Scale (i.e., more than one standard deviation (5.4) below the mean score of 29.4 in the German norm sample; The cutoff will be raised to scores below the mean of 29.4 (≤30) if not enough participants with low self-efficacy scores of ≤24 and without 12-month mental disorders are found and this leads to serious problems regarding the recruitment phase and the timeline of the project. 3. ability to participate in the course (German language proficiency, availability during the intervention period) Exclusion Criteria: 1. 12-month anxiety, affective, or substance use disorder (excluding nicotine dependence) 2. current psychological/psychopharmacological intervention or treatment seeking for psychological problems 3. acute suicidality; Individuals who report acute suicidality will be withdrawn from the study and referred to treatment.
Contact & Investigator
Eva Asselmann, Prof. Dr. rer. nat. habil.
✉ eva.asselmann@health-and-medical-university.de📞 +49 331 74 51 13 131
Frequently Asked Questions
Who can join the NCT06738953 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 30 Years, studying Depression Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06738953 currently recruiting?
Yes, NCT06738953 is actively recruiting participants. Contact the research team at eva.asselmann@health-and-medical-university.de for enrollment information.
Where is the NCT06738953 trial being conducted?
This trial is being conducted at Potsdam, Germany.
Who is sponsoring the NCT06738953 clinical trial?
NCT06738953 is sponsored by Health and Medical University Potsdam. The trial plans to enroll 378 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.