Prevention of Mental Disorders Through Self-efficacy Interventions
NCT06738953 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 378
Last updated 2024-12-18
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.
Conditions
- Depression Disorders
- Affective Disorders
- Prevention
- Substance Use Disorders
- Self-Efficacy
Interventions
- BEHAVIORAL
-
Cognitive-Behavioral Intervention to increase Self Efficacy
Participants in the intervention group will receive a brief (6 sessions of 75-90 min each) cognitive-behavioral intervention. The intervention will be delivered in an online group format (subgroups of 8-12 participants). The courses will be structured according to well-established self-efficacy interventions with proven effectiveness (Bresó et al., 2011; Cieslak et al., 2016; Luszczynska et al., 2007), targeting Bandura's four key sources of self-efficacy (i.e., mastery experience, vicarious experience, verbal persuasion, and physiological/emotional arousal). Each session will consist of a theoretical and a practical part and be structured as follows: opening, discussion of homework (with special emphasis on participants' progress and sharing of experiences), introduction to the topic, practice, answering open questions, closing. The course sessions are accompanied by weekly homework assignments to be completed at home.
- BEHAVIORAL
-
Placebo: Weekly Recap and Group Discussion on Psychological Experiments
Participants in the control group will meet in small groups (8-12 participants per group; 6 sessions, similar to the intervention group). They will receive a brief introduction to well-known psychological experiments and findings (e.g., the Asch experiment, selective attention) and discuss their perspectives on these topics, including personal implications of the experiments. Content related to self-efficacy or cognitive-behavioral interventions will be explicitly avoided. To prevent expectancy effects and other biases, participants will not be informed that they are part of the control group. If suspicions arise, participants will be told that group leaders are not allowed to disclose this. Group sessions will be led by a psychologist. The course materials (workbook, slides, and course instructions) will be shared on OSF.
Sponsors & Collaborators
-
German Research Foundation
collaborator OTHER -
Charite University, Berlin, Germany
collaborator OTHER -
Health and Medical University Potsdam
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-11-18
- Primary Completion
- 2026-04-20
- Completion
- 2026-04-20
Countries
- Germany
Study Locations
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