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Completed

NCT Number: NCT03779412

Self-help Books for Student Mental Health

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.

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Key information

Conditions

Mental Health Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Utah State University

Logan, Utah, 84322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Happiness Trap

Behavioral

Participants assigned to this condition will be asked to read this self-help book over an 8-week period.

A Mindfulness-Based Stress Reduction Workbook

Behavioral

Participants assigned to this condition will be asked to read this self-help book over an 8-week period.

Primary outcomes

  1. Change in Depression, Anxiety and Stress

    Time frame: 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.

  2. Change from Baseline Valuing Questionnaire (VQ) at 4 weeks and 8 weeks

    Time frame: 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.

  3. Change from Baseline Five Facet Mindfulness Questionnaire (FFMQ) at 4 weeks and 8 weeks.

    Time frame: 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.

Secondary outcomes

  1. Mental Health Continuum - Short Form (MHC-SF)

    Time frame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)

    A self-report measure of positive mental health, composed of three subscales assessing emotional, psychological and social well-being. Items assess theoretically meaningful dimensions of wellbeing including positive affect, satisfaction with life, social integration, social contribution, autonomy, personal growth, purpose in life, and self-acceptance. Items are rated on a 6-point scale ranging from "never" to "every day." The MHC-SF has been found to have adequate reliability and validity in past research.

  2. Counseling Center Assessment of Psychological Symptoms (CCAPS)-Academic Distress Subscale (CCMH, 2012).

    Time frame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)

    The 5-item CCAPS academic distress subscale from the CCAPS-62 will be used to assess academic functioning. Items are rated on a 5-point scale ranging from 0 "not at all like me" to 4 "Extremely like me." The CCAPS has been found to have adequate reliability and validity in past studies with college students.

  3. Acceptance and Action Questionnaire-University Students (AAQ-US).

    Time frame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)

    A self-report measure of psychological inflexibility designed specifically for university students. Items are rated on a 7-point scale ranging from 1 "never true" to 7 "always true." Although this is a new scale, preliminary research supports its reliability and validity.

  4. Cognitive Fusion Questionnaire (CFQ).

    Time frame: Baseline, Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)

    A self-report measure of cognitive fusion, an important process related to mindfulness and ACT. Items are rated on a 7-point scale ranging from 1 "never true" to 7 "always true." Initial validation study found adequate reliability and validity with populations including college students.

Other outcomes

  1. Adherence

    Time frame: Mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)

    Participants will also be asked to rate their adherence to the exercises in the book on a 7-point scale from "Did all recommended assignments" to "Did no recommended assignments."

  2. Satisfaction with the self-help book

    Time frame: Posttreatment (8 weeks after baseline)

    Participants will be asked to rate 7 items evaluating their satisfaction with the self-help book on a 6-point scale from "Strongly disagree" to "Strongly agree."

Sponsors and collaborators

Lead sponsor

Utah State University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2018
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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