Clinical trial NCT03779412: Self-help Books for Student Mental Health
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Lead sponsor: Utah State University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two active self-help interventions for the duration of the study.
Primary purpose: TREATMENT

Brief summary: 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:

1. The ACT and MBSR books will both be feasible and acceptable with college students as evidenced by equivalently high satisfaction and engagement rates.
2. The ACT and MBSR books will be equally effective in improving mental health and well-being among college students.
3. The ACT book will produce larger improvements in valued action, and the MBSR book will produce larger improvements in mindfulness.
4. 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.

Detailed description: 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.

A Mindfulness-Based Stress Reduction Workbook is based on Mindfulness-Based Stress Reduction, a standardized approach to teaching mindfulness, primarily through meditation practices. The primary treatment components in A Mindfulness-Based Stress Reduction Workbook are psychoeducation about mindfulness and mindfulness meditation and various types of mindfulness meditation practice, such as mind-body connection, loving-kindness meditation, interpersonal mindfulness, and the healthy path of mindful eating, exercise, rest, and connection.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Depression, Anxiety and Stress
timeFrame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
measure: Change from Baseline Valuing Questionnaire (VQ) at 4 weeks and 8 weeks
timeFrame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
measure: Change from Baseline Five Facet Mindfulness Questionnaire (FFMQ) at 4 weeks and 8 weeks.
timeFrame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
Secondary outcomes:
measure: Mental Health Continuum - Short Form (MHC-SF)
timeFrame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
measure: Counseling Center Assessment of Psychological Symptoms (CCAPS)-Academic Distress Subscale (CCMH, 2012).
timeFrame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
measure: Acceptance and Action Questionnaire-University Students (AAQ-US).
timeFrame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
measure: Cognitive Fusion Questionnaire (CFQ).
timeFrame: Baseline, Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
Other outcomes:
measure: Adherence
timeFrame: Mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
measure: Satisfaction with the self-help book
timeFrame: Posttreatment (8 weeks after baseline)
Locations:
city: Logan
country: United States
facility: Utah State University
state: Utah
Study officials:
affiliation: Utah State University
name: Michael Levin, PhD
role: PRINCIPAL_INVESTIGATOR
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