NCT03796143

Brief Summary

The goal of this study is to compare the efficacy of acceptance and commitment therapy (ACT) and cognitive behavioral therapy (CBT) for depression in a bibliotherapy format and assess hypothesized mechanisms of change in depression symptomatology, quality of life, and functioning. This study will test the following hypotheses:

  1. 1.CBT and ACT will both result in decreased depression, distress, and self-stigma associated with depression. Life satisfaction and values progress will increase in both conditions.
  2. 2.CBT will result in greater use of reappraisal than ACT.
  3. 3.ACT will results in greater use of defusion and decreased psychological inflexibility than CBT.
  4. 4.Changes in experiential avoidance and defusion will predict changes in depression in the ACT condition.
  5. 5.Changes in reappraisal will predict changes in depression in the CBT condition.
  6. 6.Participants who are given their choice of treatment will show better adherence and satisfaction in the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

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

January 2, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

January 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

1.6 years

First QC Date

January 2, 2019

Last Update Submit

April 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment)

Secondary Outcomes (6)

  • Self-Stigma of Depression Scale (SSDS; Barney, Griffiths, Christensen, & Jorm, 2010)

    Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment)

  • Acceptance and Action Questionnaire-II (AAQ-II; Bond et al., 2011)

    Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment)

  • Cognitive Fusion Questionnaire (CFQ; Gillanders et al., 2014)

    Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment)

  • The Behavioral Activation for Depression Scale (BADS; Kanter, Mulick, Busch, Berlin, & Martell, 2007)

    Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment)

  • Automatic Thoughts Questionnaire-Frequency (ATQ-30; Hollon & Kendall, 1980)

    Baseline, midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline), and follow-up (3-months after posttreatment)

  • +1 more secondary outcomes

Other Outcomes (2)

  • Adherence to self-help book

    Midtreatment (5 weeks after baseline), posttreatment (10 weeks after baseline)

  • Satisfaction with self-help book

    Posttreatment (10 weeks after baseline)

Study Arms (3)

ACT self-help book condition

EXPERIMENTAL

Participants in this condition will be asked to read The Mindfulness and Acceptance Workbook for Depression by Strosahl and Robinson (2008), a self-help book based on acceptance and commitment therapy.

Behavioral: The Mindfulness and Acceptance Workbook for Depression

CBT self-help book condition

ACTIVE COMPARATOR

Participants in this condition will be asked to read Cognitive Behavioral Workbook for Depression by Knaus (2006), a self-help book based on acceptance and commitment therapy.

Behavioral: The Cognitive Behavioral Workbook for Depression

Choice of two self-help books

OTHER

Participants in this condition will have the option of receiving either the self-help book by Strosahl and Robinson (2008) or the book by Knaus (2006).

Behavioral: The Mindfulness and Acceptance Workbook for DepressionBehavioral: The Cognitive Behavioral Workbook for Depression

Interventions

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

ACT self-help book conditionChoice of two self-help books

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

CBT self-help book conditionChoice of two self-help books

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 depression
  • Elevated depressive symptoms as determined by scoring a 10 or higher on the depression subscale of the Depression, Anxiety, and Stress Scale (DASS-21)

You may not qualify if:

  • Below the age of 18
  • Not a student at Utah State University
  • Have participated in other self-help studies run by the USU CBS Lab
  • Not interested in using self-help book for depression
  • No elevated depressive symptoms as determined by scoring lower than 10 on the depression subscale of the Depression, Anxiety, and Stress Scale (DASS-21)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utah State University

Logan, Utah, 84322, United States

Location

Related Publications (28)

  • 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
  • Barney LJ, Griffiths KM, Christensen H, Jorm AF. The Self-Stigma of Depression Scale (SSDS): development and psychometric evaluation of a new instrument. Int J Methods Psychiatr Res. 2010 Dec;19(4):243-54. doi: 10.1002/mpr.325.

    PMID: 20683846BACKGROUND
  • Beaufort IN, De Weert-Van Oene GH, Buwalda VAJ, de Leeuw JRJ, Goudriaan AE. The Depression, Anxiety and Stress Scale (DASS-21) as a Screener for Depression in Substance Use Disorder Inpatients: A Pilot Study. Eur Addict Res. 2017;23(5):260-268. doi: 10.1159/000485182. Epub 2017 Dec 8.

    PMID: 29224000BACKGROUND
  • Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.

    PMID: 22035996BACKGROUND
  • Fledderus M, Bohlmeijer ET, Pieterse ME, Schreurs KM. Acceptance and commitment therapy as guided self-help for psychological distress and positive mental health: a randomized controlled trial. Psychol Med. 2012 Mar;42(3):485-95. doi: 10.1017/S0033291711001206. Epub 2011 Jul 11.

    PMID: 21740624BACKGROUND
  • 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
  • Hayes, S. C., Strosahl, K. D., & Wilson, K. G. (2011). Acceptance and commitment therapy: The process and practice of mindful change. Guilford Press.

    BACKGROUND
  • Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.

    PMID: 16004657BACKGROUND
  • Hollon, S. D., & Kendall, P. C. (1980). Cognitive self-statements in depression: Development of an automatic thoughts questionnaire. Cognitive Therapy and Research, 4(4), 383-395.

    BACKGROUND
  • JimĂ©nez, F. J. R. (2012). Acceptance and commitment therapy versus traditional cognitive behavioral therapy: A systematic review and meta-analysis of current empirical evidence. International Journal of Psychology and Psychological Therapy, 12(3), 333-358.

    BACKGROUND
  • Fuhr K, Hautzinger M, Krisch K, Berking M, Ebert DD. Validation of the Behavioral Activation for Depression Scale (BADS)-Psychometric properties of the long and short form. Compr Psychiatry. 2016 Apr;66:209-18. doi: 10.1016/j.comppsych.2016.02.004. Epub 2016 Feb 9.

    PMID: 26995255BACKGROUND
  • Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.

    PMID: 12813115BACKGROUND
  • Knaus, W. J. (2006). The cognitive behavioral workbook for depression: a step-by-step program. New Harbinger Publications.

    BACKGROUND
  • Levin, M. E., Haeger, J., & Cruz, R. A. (2018). Tailoring Acceptance and Commitment Therapy Skill Coaching in the Moment Through Smartphones: Results from a Randomized Controlled Trial. Mindfulness, 1-11.

    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
  • Lorenzo-Luaces L, German RE, DeRubeis RJ. It's complicated: The relation between cognitive change procedures, cognitive change, and symptom change in cognitive therapy for depression. Clin Psychol Rev. 2015 Nov;41:3-15. doi: 10.1016/j.cpr.2014.12.003. Epub 2014 Dec 24.

    PMID: 25595660BACKGROUND
  • Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

    PMID: 7726811BACKGROUND
  • Maslej MM, Bolker BM, Russell MJ, Eaton K, Durisko Z, Hollon SD, Swanson GM, Thomson JA Jr, Mulsant BH, Andrews PW. The Mortality and Myocardial Effects of Antidepressants Are Moderated by Preexisting Cardiovascular Disease: A Meta-Analysis. Psychother Psychosom. 2017;86(5):268-282. doi: 10.1159/000477940. Epub 2017 Sep 14.

    PMID: 28903117BACKGROUND
  • Masuda, A., & Tully, E. C. (2012). The role of mindfulness and psychological flexibility in somatization, depression, anxiety, and general psychological distress in a nonclinical college sample. Journal of Evidence-Based Complementary & Alternative Medicine, 17(1), 66-71.

    BACKGROUND
  • Mohr DC, Hart SL, Howard I, Julian L, Vella L, Catledge C, Feldman MD. Barriers to psychotherapy among depressed and nondepressed primary care patients. Ann Behav Med. 2006 Dec;32(3):254-8. doi: 10.1207/s15324796abm3203_12.

    PMID: 17107299BACKGROUND
  • Reynolds M, Wells A. The Thought Control Questionnaire--psychometric properties in a clinical sample, and relationships with PTSD and depression. Psychol Med. 1999 Sep;29(5):1089-99. doi: 10.1017/s003329179900104x.

    PMID: 10576301BACKGROUND
  • Ridgway N, Williams C. Cognitive behavioural therapy self-help for depression: an overview. J Ment Health. 2011 Dec;20(6):593-603. doi: 10.3109/09638237.2011.613956.

    PMID: 22126636BACKGROUND
  • Rokke PD, Tomhave JA, Jocic Z. The role of client choice and target selection in self-management therapy for depression in older adults. Psychol Aging. 1999 Mar;14(1):155-69. doi: 10.1037//0882-7974.14.1.155.

    PMID: 10224639BACKGROUND
  • Strosahl, K. D., & Robinson, P. J. (2008). The mindfulness and acceptance workbook for depression: Using acceptance and commitment therapy to move through depression and create a life worth living. New Harbinger Publications.

    BACKGROUND
  • Tompkins KA, Swift JK, Callahan JL. Working with clients by incorporating their preferences. Psychotherapy (Chic). 2013 Sep;50(3):279-83. doi: 10.1037/a0032031.

    PMID: 24000835BACKGROUND
  • van Schaik DJ, Klijn AF, van Hout HP, van Marwijk HW, Beekman AT, de Haan M, van Dyck R. Patients' preferences in the treatment of depressive disorder in primary care. Gen Hosp Psychiatry. 2004 May-Jun;26(3):184-9. doi: 10.1016/j.genhosppsych.2003.12.001.

    PMID: 15121346BACKGROUND
  • Wells A, Davies MI. The Thought Control Questionnaire: a measure of individual differences in the control of unwanted thoughts. Behav Res Ther. 1994 Nov;32(8):871-8. doi: 10.1016/0005-7967(94)90168-6.

    PMID: 7993332BACKGROUND
  • Wing RR, Phelan S, Tate D. The role of adherence in mediating the relationship between depression and health outcomes. J Psychosom Res. 2002 Oct;53(4):877-81. doi: 10.1016/s0022-3999(02)00315-x.

    PMID: 12377297BACKGROUND

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, or their choice of intervention, for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 8, 2019

Study Start

January 7, 2019

Primary Completion

August 15, 2020

Study Completion

August 15, 2020

Last Updated

April 27, 2021

Record last verified: 2021-04

Locations