Prevention of Mental Disorders Through Self-efficacy Interventions

NCT06738953 | Recruiting

• 1 other identifier: GEPRIS:534641939
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression Disorders; Affective Disorders; Prevention; Substance Use Disorders; Self-Efficacy

Keywords

Prevention; Transdiagnostic; Young Adults; Online Intervention; Mental Health; Self-Efficacy; Depressive Disorders; Anxiety Disorders; Substance Use Disorders

Outcome Measures

Primary Outcomes (2)

• Change in general self-efficacy measured by the German version of the General Self-Efficacy Scale (GSE)

  Change in general self-efficacy from baseline to post in the intervention group compared to the control group. The baseline measurement is taken immediately before the course starts, and the post measurement is taken within two weeks after the course ends. The interval between the two measurements is approximately 8-10 weeks, depending on participant availability. The German version of the General Self-Efficacy Scale (GSE) will be used. Scores range from 10 to 40, with higher scores indicating greater self-efficacy.

  From baseline to post (approximately 8-10 weeks).

• Rates of incident DSM-5 mental disorders assessed by the SCID-CV.

  Rates of incident DSM-5 mental disorders from baseline to follow-up in the intervention group compared to the control group. Assessments occur at baseline and follow-up (approximately 14 months apart). Diagnoses will be made using the Structured Clinical Interview for DSM-5 (SCID-CV), focusing on sections A, D, E, and F, while sub-treshold symptoms are also assessed.

  From baseline to follow-up (approximately 14 months).

Secondary Outcomes (9)

• Change in dimensional psychopathological symptoms measured by the DSM-5 Cross-Cutting-Symptom-Measure.

  From baseline to post (approximately 8-10 weeks).

• Change in dimensional psychopathological symptoms measured by the DSM-5 Cross-Cutting-Symptom-Measure.

  From baseline to follow-up (approximately 14 months).

• Change in self-esteem measured by the German version of the Rosenberg Self-Esteem Scale.

  From baseline to post (approximately 8-10 weeks) and to follow-up (approximately 14 months).

• Change in perceived control measured by the German version of the Perceived Control Scale (IE-4).

  From baseline to post (approximately 8-10 weeks) and to follow-up (approximately 14 months).

• Change in perceived social support measured by the German version of the Multidimensional Scale of Perceived Social Support (MSPSS).

  From baseline to post (approximately 8-10 weeks) and to follow-up (approximately 14 months).

Study Arms (2)

Behavioral: Cognitive-behavioral intervention to increase self-efficacy

EXPERIMENTAL

n = 189 participants will be allocated randomly to this study arm.

Behavioral: Cognitive-Behavioral Intervention to increase Self Efficacy

Behavioral: Group Discussion on Psychological Experiments as active Control

PLACEBO COMPARATOR

n = 189 participants will be allocated randomly to this study arm.

Behavioral: Placebo: Weekly Recap and Group Discussion on Psychological Experiments

Interventions

Cognitive-Behavioral Intervention to increase Self Efficacy BEHAVIORAL

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: Cognitive-behavioral intervention to increase self-efficacy

Placebo: Weekly Recap and Group Discussion on Psychological Experiments BEHAVIORAL

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.

Behavioral: Group Discussion on Psychological Experiments as active Control

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-30 years and
• 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.
• ability to participate in the course (German language proficiency, availability during the intervention period)

You may not qualify if:

• month anxiety, affective, or substance use disorder (excluding nicotine dependence)
• current psychological/psychopharmacological intervention or treatment seeking for psychological problems
• acute suicidality; Individuals who report acute suicidality will be withdrawn from the study and referred to treatment.

Sponsors & Collaborators

• Health and Medical University Potsdam: lead
• German Research Foundation: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Health and Medical University Potsdam

Potsdam, Brandenburg, 14471, Germany

RECRUITING

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Related Links

• Study website

MeSH Terms

Conditions

Mood Disorders; Substance-Related Disorders; Psychological Well-Being; Depressive Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Chemically-Induced Disorders; Personal Satisfaction; Behavior

Central Study Contacts

Eva Asselmann, Prof. Dr. rer. nat. habil.

CONTACT

+49 331 74 51 13 131; eva.asselmann@health-and-medical-university.de

Felix D Gross, M. Sc. Psychology

CONTACT

+49 331 74 51 13 131; felix.gross@hmu-potsdam.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator, Professor of Differential and Personality Psychology

Model Details: Randomized Controlled Selective Preventive Intervention Study

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 18, 2024
• Study Start: November 18, 2024
• Primary Completion: April 20, 2026
• Study Completion: April 20, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After the end of the study
• Access Criteria: Everyone; no restrictions

Locations

DE (1)