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

NCT ID: NCT04757961

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-17
• Study Completion Date: 2023-05-08

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.

Detailed Description

The purpose of this study is to test the efficacy of an online, self-guided ACT-based narrative intervention for adults currently taking antidepressant medication. To test the effects of LifeStories on depression severity, quality of life, general functioning and psychological inflexibility, the investigators will conduct a randomized controlled trial with two conditions (LifeStories and waitlist control) using a sample of 90 adults currently taking antidepressant medication. Interested individuals will complete a screening survey to determine eligibility. After being informed about the study and potential risks, eligible participants who provide informed consent will be asked to complete a baseline survey. Participants will then be randomized to LifeStories or a waitlist control conditions, each lasting 4 weeks. Those 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. Participants in both groups will be asked to complete a midtreatment survey 2 weeks after baseline, and a posttreatment survey 4 weeks after baseline (i.e. after completing the 4-week video intervention for those in the active condition).

Conditions

Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Lifestories

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

Group Type: EXPERIMENTAL

LifeStories

Intervention Type: 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.

Waitlist Control Condition

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LifeStories

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 18 years of age or older

2. Currently residing in the United States

3. Currently taking antidepressant medication prescribed by a primary care provider (PCP)

4. Meets criteria for at least moderate depression on the 9-item Patient Health Questionnaire

5. Fluent in English

6. Reliable access to an internet browser, and internet speed that is sufficient for streaming online videos

Exclusion Criteria

1. Change in medication regimen in past 6 weeks

2. Presently seeing a mental health specialist (e.g. psychologist, psychiatrist, counselor, social worker)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Utah State University

OTHER

Sponsor Role: lead

Responsible Party

Michael Levin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael E Levin, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Utah State University

Locations

Utah State University

Logan, Utah, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: 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.

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Reference Type: 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.

Reference Type: DERIVED

PMID: 37855277 (View on PubMed)

Other Identifiers

11523

Identifier Type: -

Identifier Source: org_study_id