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

Not Applicable

Completed

• Conditions: Depressive Symptoms
• Interventions: Behavioral: LifeStories

• Registration Number: NCT04757961
• Lead Sponsor: Utah State University

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).

Study Timeline

• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-16
• Study Start: 2021-02-17
• Study First Posted: 2021-02-17
• Primary Completion: 2021-12-01
• Status Verified: 2023-05
• Study Completion: 2023-05-08
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lifestories	LifeStories	Participants in this condition will be actively participating in the online intervention for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change in depression severity	Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline)	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.

Secondary Outcome Measures

Name	Time	Method
Change in health-related quality of life	Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline)	Short Form Health Survey (SF-12; Ware et al., 1996): The SF-12 is a 12-item measure of quality of life and general functioning. Respondents are asked to rate their present level of health or emotion-related impairment in daily activities. Items are rated on a scale from 1 "all of the time" to 6 "none of the time," with higher scores indicating greater health-related quality of life.
Change in psychological inflexibility	Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline)	Acceptance and Action Questionnaire-II (AAQ-II; Bond et al., 2011): The AAQ-II is a 10-item measure of psychological inflexibility and experiential avoidance. Items are rated on a 7-point scale ranging from 1 "never true" to 7 "always true." A total score is calculated by reverse coding so that higher scores indicate greater psychological flexibility.

Trial Locations

Locations (1)

Utah State University; 🇺🇸 Logan, Utah, United States