- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03779412
Self-help Books for Student Mental Health
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Utah
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Logan, Utah, United States, 84322
- Utah State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: ACT self-help book condition
Participants in this condition will be assigned to read The Happiness Trap by Harris (2008), a self-help book based on acceptance and commitment therapy.
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Participants assigned to this condition will be asked to read this self-help book over an 8-week period.
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Active Comparator: MBSR self-help book condition
Participants in this condition will be assigned to read A Mindfulness-Based Stress Reduction Workbook by Stahl and Goldstein (2010), a self-help book based on Mindfulness-Based Stress Reduction.
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Participants assigned to this condition will be asked to read this self-help book over an 8-week period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Depression, Anxiety and Stress
Time Frame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
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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.
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Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
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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)
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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.
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Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
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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)
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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.
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Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mental Health Continuum - Short Form (MHC-SF)
Time Frame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
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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.
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Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
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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)
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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.
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Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
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Acceptance and Action Questionnaire-University Students (AAQ-US).
Time Frame: Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
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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.
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Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
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Cognitive Fusion Questionnaire (CFQ).
Time Frame: Baseline, Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
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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.
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Baseline, Baseline, mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence
Time Frame: Mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
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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."
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Mid-treatment (4 weeks after baseline), and posttreatment (8 weeks after baseline)
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Satisfaction with the self-help book
Time Frame: Posttreatment (8 weeks after baseline)
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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."
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Posttreatment (8 weeks after baseline)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Levin, PhD, Utah State University
Publications and helpful links
General Publications
- Gillanders DT, Bolderston H, Bond FW, Dempster M, Flaxman PE, Campbell L, Kerr S, Tansey L, Noel P, Ferenbach C, Masley S, Roach L, Lloyd J, May L, Clarke S, Remington B. The development and initial validation of the cognitive fusion questionnaire. Behav Ther. 2014 Jan;45(1):83-101. doi: 10.1016/j.beth.2013.09.001. Epub 2013 Sep 18.
- Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
- Keyes CL. Mental illness and/or mental health? Investigating axioms of the complete state model of health. J Consult Clin Psychol. 2005 Jun;73(3):539-48. doi: 10.1037/0022-006X.73.3.539.
- McCracken LM, Chilcot J, Norton S. Further development in the assessment of psychological flexibility: a shortened Committed Action Questionnaire (CAQ-8). Eur J Pain. 2015 May;19(5):677-85. doi: 10.1002/ejp.589. Epub 2014 Sep 2.
- Abramowitz JS, Moore EL, Braddock AE, Harrington DL. Self-help cognitive-behavioral therapy with minimal therapist contact for social phobia: a controlled trial. J Behav Ther Exp Psychiatry. 2009 Mar;40(1):98-105. doi: 10.1016/j.jbtep.2008.04.004. Epub 2008 Apr 26.
- Blanco C, Okuda M, Wright C, Hasin DS, Grant BF, Liu SM, Olfson M. Mental health of college students and their non-college-attending peers: results from the National Epidemiologic Study on Alcohol and Related Conditions. Arch Gen Psychiatry. 2008 Dec;65(12):1429-37. doi: 10.1001/archpsyc.65.12.1429.
- Levin ME, Pistorello J, Seeley JR, Hayes SC. Feasibility of a prototype web-based acceptance and commitment therapy prevention program for college students. J Am Coll Health. 2014;62(1):20-30. doi: 10.1080/07448481.2013.843533.
- Center for Collegiate Mental Health (2012). CCAPS 2012 Technical Manual. University Park, PA
- Harris, R. (2007). The happiness trap: How to stop struggling and start living. Penguin Random House.
- Hayes, S. C., Strosahl, K. D., & Wilson, K. G. (2011). Acceptance and Commitment Therapy: The process and practice of mindful change. New York: The Guilford Press.
- Hayes SC, Villatte M, Levin M, Hildebrandt M. Open, aware, and active: contextual approaches as an emerging trend in the behavioral and cognitive therapies. Annu Rev Clin Psychol. 2011;7:141-68. doi: 10.1146/annurev-clinpsy-032210-104449.
- Hunt J, Eisenberg D. Mental health problems and help-seeking behavior among college students. J Adolesc Health. 2010 Jan;46(1):3-10. doi: 10.1016/j.jadohealth.2009.08.008. Epub 2009 Oct 20.
- Kabat-Zinn J. (1990). Full Catastrophe Living. New York: Delacorte.
- Levin ME, Krafft J, Levin C. Does self-help increase rates of help seeking for student mental health problems by minimizing stigma as a barrier? J Am Coll Health. 2018 May-Jun;66(4):302-309. doi: 10.1080/07448481.2018.1440580. Epub 2018 Apr 19.
- Levin, M.E., Krafft, J., Pistorello, J. & Seeley, J.R. (In Press). Assessing psychological inflexibility in university students: Development and validation of the acceptance and action questionnaire for university students (AAQ-US). Journal of Contextual Behavioral Science.
- Levin, M.E., Stocke, K., Pierce, B. & Levin, C. (2018). Do college students use online self-help? A survey of intentions and use of mental health resources. Journal of College Student Psychotherapy, 32, 181-198.
- Lovibond, S. H. & Lovibond, P. F. (1995). Manual for the Depression Anxiety Stress Scales, (2nd ed.). Sydney, AU: Psychology Foundation of Australia.
- Rosen, G.M., & Lilienfeld, S.O. (2016). On the failure of psychology to advance self-help: Acceptance and Commitment Therapy (ACT) as a case example. Journal of Contemporary Psychotherapy, 46, 71-77.
- Sevilla-Llewellyn-Jones J, Santesteban-Echarri O, Pryor I, McGorry P, Alvarez-Jimenez M. Web-Based Mindfulness Interventions for Mental Health Treatment: Systematic Review and Meta-Analysis. JMIR Ment Health. 2018 Sep 25;5(3):e10278. doi: 10.2196/10278.
- Smout, M.F., Davies, M., Burns, N., & Christie, A. (2014). Evaluating acceptance and commitment therapy: Development of the valuing questionnaire. Journal of Contextual Behavioral Science, 3, 164-172.
- Stahl, B. & Goldstein, E. (2010). A Mindfulness-Based Stress Reduction Workbook. New Harbinger Publications
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 9792
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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