Clinical trial NCT04757961: Evaluation of an Acceptance and Commitment Therapy-Based Narrative Intervention for Individuals Taking Antidepressants
Official title: Evaluation of an ACT-based Narrative Intervention for Individuals Taking Antidepressant Medication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Keywords: ACT
narrative intervention
story-telling intervention
depression
antidepressant
Lead sponsor: Utah State University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly assigned with equal likelihood to receive the online ACT-based intervention (LifeStories) or the waitlist control condition.
Primary purpose: SUPPORTIVE_CARE

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).

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)

Primary outcomes:
measure: Change in depression severity
timeFrame: Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline)
Secondary outcomes:
measure: Change in health-related quality of life
timeFrame: Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline)
measure: Change in psychological inflexibility
timeFrame: Baseline, Mid-treatment (2 weeks post baseline), Post-treatment (4 weeks post baseline)
Other outcomes:
measure: Changes in treatment preferences
timeFrame: Baseline, Post-treatment (4 weeks post baseline)
measure: Treatment adherence
timeFrame: Post-treatment (4 weeks post baseline)
measure: Treatment satisfaction
timeFrame: Post-treatment (4 weeks post baseline)
measure: Changes in treatment utilization
timeFrame: Baseline, post-treatment (4 weeks post baseline)
Locations:
city: Logan
country: United States
facility: Utah State University
state: Utah
Study officials:
affiliation: Utah State University
name: Michael E Levin, Ph.D
role: PRINCIPAL_INVESTIGATOR
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