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Completed

NCT Number: NCT04757961

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Utah State University

Logan, Utah, 84322, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Change in depression severity

    Time frame: 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 outcomes

  1. Change in health-related quality of life

    Time frame: 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.

  2. Change in psychological inflexibility

    Time frame: 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.

Other outcomes

  1. Changes in treatment preferences

    Time frame: Baseline, Post-treatment (4 weeks post baseline)

    General Help Seeking Questionnaire (GHSQ; Wilson, Deane, Ciarocchi, & Rickwood): We will use an adapted version of the GHSQ which is a validated measure of help-seeking intentions from a variety of formal (e.g. psychologist, PCP) and informal (e.g. friends, family) supports, rated on a 7-point scale from 1 "extremely likely" to 7 "extremely unlikely," with higher scores on each item indicating greater likelihood of seeking help from that source.

  2. Treatment adherence

    Time frame: Post-treatment (4 weeks post baseline)

    Participants will be asked to rate their adherence to the homework exercises from the online program on a 7-point scale from 1 "did no recommended assignments" to 7 "did all recommended assignments," using a scale adapted from previous self-help studies (Abramowitz, Moore, Braddock, & Harrington, 2009). Higher scores on this measure indicate greater treatment adherence.

  3. Treatment satisfaction

    Time frame: Post-treatment (4 weeks post baseline)

    System Usability Scale (SUS; Brooke, 1996): The SUS is a 10-item measure of usability and satisfaction with programs with established reliability and validity (Lewis, 2009). Items on the SUS are rated on a scale from 1 "strongly disagree" to 5 "strongly disagree, with higher scores indicating greater treatment satisfaction. We will additionally ask those in the active condition a series of free-response questions assessing their favorite and least favorite aspects of LifeStories, as well as their perspectives on how using the program may have helped them manage depression.

  4. Changes in treatment utilization

    Time frame: Baseline, post-treatment (4 weeks post baseline)

    We will ask participants at baseline and post-treatment a series of yes/no questions that we constructed which ask if they are engaged in treatment with a mental health specialist, are planning to see a mental health specialist, or have made any recent changes to their antidepressant treatment.

Sponsors and collaborators

Lead sponsor

Utah State University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Feb 17, 2021
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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