Preventing Mental Disorders in Young Adults with Low Self-efficacy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- Change in general self-efficacy measured by the German version of the General Self-Efficacy Scale (GSE)
研究概览
简要总结
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.
详细描述
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, the investigators 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.
Detailed Description Based on previous research, it is plausible that self-efficacy training may have positive mental health effects and thus successfully prevent the development of mental disorders over time: Consistent with social cognitive theory, self-efficacy training may reduce feelings of anxiety and thus reduce the risk of anxiety disorders. According to the theory of learned helplessness, self-efficacy training may reduce feelings of helplessness and depression and thus reduce the risk of affective disorders. In addition, and consistent with the self-medication hypothesis, individuals who receive self-efficacy training may be less likely to use tobacco, alcohol, or medication/illicit drugs to avoid or down-regulate unpleasant feelings, thereby reducing the risk of substance use disorders.
However, although self-efficacy interventions have been shown to be beneficial in other domains, it remains unclear whether self-efficacy training can effectively prevent the onset of full-threshold anxiety, affective, and substance use disorders in young adults. Given that selective and indicated prevention has been shown to be particularly effective in high-risk samples young adults with low self-efficacy and thus increased risk for mental disorders may benefit from targeted self-efficacy training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 30 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •12-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.
研究组 & 干预措施
Behavioral: Cognitive-behavioral intervention to increase self-efficacy
n = 189 participants will be allocated randomly to this study arm.
干预措施: Cognitive-Behavioral Intervention to increase Self Efficacy (Behavioral)
Behavioral: Group Discussion on Psychological Experiments as active Control
n = 189 participants will be allocated randomly to this study arm.
干预措施: Placebo: Weekly Recap and Group Discussion on Psychological Experiments (Behavioral)
结局指标
主要结局
Change in general self-efficacy measured by the German version of the General Self-Efficacy Scale (GSE)
时间窗: From baseline to post (approximately 8-10 weeks).
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.
Rates of incident DSM-5 mental disorders assessed by the SCID-CV.
时间窗: From baseline to follow-up (approximately 14 months).
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.
次要结局
- 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).)
- Change in coping measured by the German version of the COPE Inventory (28 items).(From baseline to post (approximately 8-10 weeks) and to follow-up (approximately 14 months).)
- Change in interpersonal competence measured by the German version of the Interpersonal Competence Questionnaire (ICQ-15).(From baseline to post (approximately 8-10 weeks) and to follow-up (approximately 14 months).)
- Change in work engagement measured by the German version of the Utrecht Work Engagement Scale (UWES-9).(From baseline to post (approximately 8-10 weeks) and to follow-up (approximately 14 months).)
- Change in individual work performance measured by the German version of the Individual Work Performance Questionnaire (IWPQ-18).(From baseline to post (approximately 8-10 weeks) and to follow-up (approximately 14 months).)
- Change in dimensional psychopathological symptoms measured by the DSM-5 Cross-Cutting-Symptom-Measure.(From baseline to post (approximately 8-10 weeks).)
研究者
Prof. Dr. Eva Asselmann
Prinicipal Investigator, Professor of Differential and Personality Psychology
Health and Medical University Potsdam
