A Randomized Controlled Trial (RCT) Comparing Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Stress Reduction (MBSR) Self-help Books for College Student Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Change in Depression, Anxiety and Stress
研究概览
简要总结
The goal of this study is to compare the efficacy and mechanisms of change of two self-help books for college student mental health in a randomized controlled trial. One book is based on mindfulness-based stress reduction (MBSR), and one is based on acceptance and commitment therapy (ACT).
This study will test the following hypotheses:
- The ACT and MBSR books will both be feasible and acceptable with college students as evidenced by equivalently high satisfaction and engagement rates.
- The ACT and MBSR books will be equally effective in improving mental health and well-being among college students.
- The ACT book will produce larger improvements in valued action, and the MBSR book will produce larger improvements in mindfulness.
- Valued action will be a stronger predictor of improvements in mental health in the ACT condition and mindfulness will be a stronger predictor of improvements in the mindfulness condition.
详细描述
The investigators aim to recruit 150 college students for this RCT (75 per treatment condition). This will provide adequate power (0.80) to detect differences between groups of medium effect size (d=0.50). Note that detailed eligibility criteria are listed in the "Eligibility" section. Participants will be recruited via SONA (a participant recruitment system), flyers, online postings, classroom announcements, and through a general online screener for various Utah State University (USU) Contextual Behavioral Science (CBS) Lab studies.
Total study participation will occur over approximately 8 weeks. all study procedures will be completed online, on a computer/mobile phone. After completing informed consent, participants will complete a baseline survey.
At the end of the baseline survey, participants will be randomly assigned to use a book based on ACT (The Happiness Trap) or MBSR (A Mindfulness-Based Stress Reduction Workbook). Participants will be asked not to access other self-help books during the study duration. Participants will be provided with an 8-week reading schedule and a link to the assigned book. Participants will be asked to complete a mid-treatment survey 4 weeks after the beginning of treatment. The mid-treatment survey will include questions about adherence. Participants will be asked to complete a post-treatment survey 8 weeks after the beginning of treatment. This survey will also ask about adherence (reading, use of strategies taught in the book). Researcher contact will involve reminders to complete assessments, basic email assistance in identifying and responding to any barriers to using the self-help book, and twice-weekly reminders of the suggested reading schedule.
After completing the initial assessment participants will be sent a link to The Happiness Trap if they are assigned to the ACT condition, or a link to the Mindfulness-Based Stress Reduction Workbook if they are in the MBSR condition. They will be able to access the book online at any time. Participants will be asked to read assigned chapters on an 8-week schedule.
The Happiness Trap is based on Acceptance and Commitment Therapy, a modern cognitive behavioral therapy that combines acceptance and mindfulness methods with values and behavior change methods. The primary treatment components in The Happiness Trap are psychoeducation of ACT, defusion, acceptance, mindfulness, self-as-context, value, behavioral commitment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Enrolled at Utah State University
- •Have not participated in other self-help studies run by the USU CBS Lab
- •Interested in using self-help book for improving mental health and well-being
排除标准
- •Below the age of 18
- •Not a student at Utah State University
- •Have participated in previous self-help studies run by the CBS Lab
- •Not interested in using a self-help book for improving mental health and well-being
结局指标
主要结局
Change in Depression, Anxiety and Stress
时间窗: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
Depression, Anxiety and Stress Scale (DASS) : a self-report measure of depression, anxiety, and stress symptoms. Higher scores indicate higher negative emotional states of depression, anxiety, and stress. This measure assesses each of these symptoms as a distinct subscale. Items are rated on a 4-point scale ranging from 0 "did not apply to me at all" to 3 "applied to me very much, or most of the time." Ranges for depression, anxiety, and stress are 0-28, 0-20, and 0-33, respectively.
Change from Baseline Valuing Questionnaire (VQ) at 4 weeks and 8 weeks
时间窗: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
A self-report measure of valued action. This is a 10-item measure, and each item is rated on a 7-point scale ranging from 0 "not at all true" to 6 "completely true." The VQ is a new measure, but initial validation results indicate adequate reliability and validity.
Change from Baseline Five Facet Mindfulness Questionnaire (FFMQ) at 4 weeks and 8 weeks.
时间窗: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
A self-report measure of five facets of mindfulness: observing, describing, acting with awareness, being nonjudgmental, and nonreactivity. The FFMQ is a 39-item questionnaire, and each FFMQ item is rated on a 5-point scale ranging from 1 ("never or very rarely true") to 5 ("very often or always true"). The FFMQ has been found to be a reliable and valid measure of mindfulness in past research.
次要结局
- Mental Health Continuum - Short Form (MHC-SF)(Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline))
- Counseling Center Assessment of Psychological Symptoms (CCAPS)-Academic Distress Subscale (CCMH, 2012).(Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline))
- Acceptance and Action Questionnaire-University Students (AAQ-US).(Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline))
- Cognitive Fusion Questionnaire (CFQ).(Baseline, Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline))
研究者
Michael Levin
Associate Professor
Utah State University