NCT03779412

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. 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. 2.The ACT and MBSR books will be equally effective in improving mental health and well-being among college students.
  3. 3.The ACT book will produce larger improvements in valued action, and the MBSR book will produce larger improvements in mindfulness.
  4. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

January 7, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

December 10, 2018

Last Update Submit

March 23, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Depression, Anxiety and Stress

    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.

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

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

    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.

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

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

    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.

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

Secondary Outcomes (4)

  • 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)

Other Outcomes (2)

  • Adherence

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

  • Satisfaction with the self-help book

    Posttreatment (8 weeks after baseline)

Study Arms (2)

ACT self-help book condition

EXPERIMENTAL

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.

Behavioral: The Happiness Trap

MBSR self-help book condition

ACTIVE COMPARATOR

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.

Behavioral: A Mindfulness-Based Stress Reduction Workbook

Interventions

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

ACT self-help book condition

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

MBSR self-help book condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utah State University

Logan, Utah, 84322, United States

Location

Related Publications (21)

  • 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.

    PMID: 18514614BACKGROUND
  • 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.

    PMID: 16443717BACKGROUND
  • 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.

    PMID: 19047530BACKGROUND
  • Center for Collegiate Mental Health (2012). CCAPS 2012 Technical Manual. University Park, PA

    BACKGROUND
  • 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.

    PMID: 24411117BACKGROUND
  • Harris, R. (2007). The happiness trap: How to stop struggling and start living. Penguin Random House.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 21219193BACKGROUND
  • 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.

    PMID: 20123251BACKGROUND
  • Kabat-Zinn J. (1990). Full Catastrophe Living. New York: Delacorte.

    BACKGROUND
  • 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.

    PMID: 15982151BACKGROUND
  • 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.

    PMID: 29447600BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 24313693BACKGROUND
  • 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.

    BACKGROUND
  • Lovibond, S. H. & Lovibond, P. F. (1995). Manual for the Depression Anxiety Stress Scales, (2nd ed.). Sydney, AU: Psychology Foundation of Australia.

    BACKGROUND
  • 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.

    PMID: 25181605BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 30274963BACKGROUND
  • 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.

    BACKGROUND
  • Stahl, B. & Goldstein, E. (2010). A Mindfulness-Based Stress Reduction Workbook. New Harbinger Publications

    BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Michael Levin, PhD

    Utah State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two active self-help interventions for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 10, 2018

First Posted

December 19, 2018

Study Start

January 7, 2019

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations