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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Evaluation of an ACT-based Narrative Intervention for Individuals Taking Antidepressant Medication

Conditions
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Depressive Symptoms

Intervention / Treatment
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* Behavioral: LifeStories


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 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 Exclusion Criteria: Change in medication regimen in past 6 weeks Presently seeing a mental health specialist (e.g. psychologist, psychiatrist, counselor, social worker)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will be randomly assigned with equal likelihood to receive the online ACT-based intervention (LifeStories) or the waitlist control condition.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestories<br>Participants in this condition will be actively participating in the online intervention for 4 weeks. | Behavioral: LifeStories<br>* 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.<br>|
| No Intervention: Waitlist Control Condition<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health-related quality of life | 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. | Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline) | 
| Change in psychological inflexibility | 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. | Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACT, narrative intervention, story-telling intervention, depression, antidepressant