Evaluation of an Acceptance and Commitment Therapy-Based Narrative Intervention for Individuals Taking Antidepressants

NCT04757961 | Completed

• 1 other identifier: 11523
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy of LifeStories on depression symptomatology compared to antidepressant treatment alone, in addition to examining the effect of the intervention on health-related quality of life. Participants will be randomly assigned to either an online ACT-based narrative intervention (Lifestories) or the waitlist control condition (antidepressant treatment alone). It is hypothesized that participants who receive the LifeStories will result in decreased depression and increased quality of life, general functioning and decreased psychological inflexibility compared to the waitlist group.

Conditions

Depressive Symptoms

Keywords

ACT; narrative intervention; story-telling intervention; depression; antidepressant

Outcome Measures

Primary Outcomes (1)

• Change in depression severity

  Patient Health Questionnaire 9-item (PHQ-9; Kroenke et al., 2001): The PHQ is a 9-item measure of depression severity, which asks respondents to report their frequency of depressive symptoms over the past two weeks, rated from 0 "not at all" to 3 "nearly every day". The PHQ-9 provides a total score which indicates current depression severity according to the following levels: minimal, mild, moderate, moderately severe, and severe. Higher scores indicate higher depression.

  Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline)

Secondary Outcomes (2)

• Change in health-related quality of life

  Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline)

• Change in psychological inflexibility

  Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline)

Other Outcomes (4)

• Changes in treatment preferences

  Baseline, Post-treatment (4 weeks post baseline)

• Treatment adherence

  Post-treatment (4 weeks post baseline)

• Treatment satisfaction

  Post-treatment (4 weeks post baseline)

Study Arms (2)

Lifestories

EXPERIMENTAL

Participants in this condition will be actively participating in the online intervention for 4 weeks.

Behavioral: LifeStories

Waitlist Control Condition

NO INTERVENTION

Participant in the waitlist group will be asked to not use other self-help websites or books for four weeks, after which they will be given weekly access to LifeStories modules. All participants will be asked to continue their antidepressant treatment as usual as directed by their primary care provider.

Interventions

LifeStories BEHAVIORAL

The content of LifeStories is divided thematically into core ACT concepts across the four episodes as follows: 1) cultivating awareness of the transient nature of mood experiences and the benefit of trying out various strategies to cope with depression when it arises; 2) clarifying one's own values and setting personal goals related to these values; 3) developing a more accepting and nonjudgmental stance towards difficult thoughts and feelings and practicing self-compassion;and 4) living more mindfully in the present moment.

Lifestories

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Currently residing in the United States
• Currently taking antidepressant medication prescribed by a primary care provider (PCP)
• Meets criteria for at least moderate depression on the 9-item Patient Health Questionnaire
• Fluent in English
• Reliable access to an internet browser, and internet speed that is sufficient for streaming online videos

You may not qualify if:

• Change in medication regimen in past 6 weeks
• Presently seeing a mental health specialist (e.g. psychologist, psychiatrist, counselor, social worker)

Sponsors & Collaborators

• Utah State University: lead

Study Sites (1)

Utah State University

Logan, Utah, 84322, United States

Location

Related Publications (9)

• 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: 18514614 BACKGROUND

• 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: 22035996 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

  PMID: 8628042 BACKGROUND

• Wilson, C.J., Deane, F.P., Ciarrochi, J. & Rickwood, D. (2005). Measuring help-seeking intentions: Properties of the General Help-Seeking Questionnaire. Canadian Journal of Counselling, 39(1), 15-28.

  BACKGROUND

• Brooke, J. (1996). SUS: A "Quick and Dirty" Usability Scale. In: Jordan, P.W., Thomas, B., Weerdmeester, B.A., McClelland (eds.) Usability Evaluation in Industry, pp. 189-194. Taylor & Francis, London.

  BACKGROUND

• 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(3), 181-198.

  BACKGROUND

• Lewis, J. R., & Sauro, J. (2009, July). The factor structure of the system usability scale. In International Conference on Human Centered Design (pp. 94-103). Springer, Berlin, Heidelberg.

  BACKGROUND

• Davis CH, Donahue ML, Gaudiano BA, Uebelacker LA, Twohig MP, Levin ME. Adding online storytelling-based acceptance and commitment therapy to antidepressant treatment for primary care patients: a randomized clinical trial. Cogn Behav Ther. 2024 Jan;53(1):48-69. doi: 10.1080/16506073.2023.2265560. Epub 2024 Jan 2.

  PMID: 37855277 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Michael E Levin, Ph.D

  Utah State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned with equal likelihood to receive the online ACT-based intervention (LifeStories) or the waitlist control condition.

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 17, 2021
• Study Start: February 17, 2021
• Primary Completion: December 1, 2021
• Study Completion: May 8, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)