An interventional study of aTAU + sTVi and aTAU + Attention Control Videos in Major Depressive Disorder, sponsored by Butler Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Butler Hospital · Not applicable, Interventional, and Treatment
The overall aim of this program of research is to refine and test a newly developed storytelling video intervention (sTVi) for depressed primary care patients.
The purpose of the proposed project is to establish the feasibility, acceptability, and preliminary effects of the intervention for an eventual large-scale randomized clinical trial which would test the efficacy of sTVi in comparison to a control condition.
To achieve the specific aims, the investigators will conduct a pilot randomized clinical trial (n = 40), with two treatment arms: antidepressant treatment as usual (aTAU) + sTVI vs aTAU + attention control videos.
The public health impact of existing treatments for major depression is limited by our ability to disseminate those treatments. There is a particular need to find innovative ways to disseminate key principles of empirically supported psychotherapy in primary care settings. Narrative communication is an alternative way to disseminate psychotherapy behavior change principles. Narrative communication refers to "storytelling" -real people talking about their struggles and successful ways of coping. An advantage of narrative communication is that it can be easily distributed (by video) and may reach people who do not have access to other technologies or who experience barriers to traditional psychotherapy. We propose that key principles of a type of cognitive-behavioral therapy (Acceptance and Commitment Therapy, or ACT) can be readily disseminated through a video storytelling intervention. Together with a video production firm with a record of working in healthcare and developing documentary-style videos, we will produce a storytelling video intervention (sTVi).
Our specific aim is to conduct a pilot randomized controlled trial (n = 40) with depressed primary care patients who will receive either antidepressant treatment as usual (aTAU) + sTVi vs aTAU + attention control videos. Assessments will occur at baseline, 4 (post-treatment) and 12 weeks (follow-up). We will examine feasibility and acceptability of sTVi (e.g., uptake and completion of sTVi, engagement with videos, and understanding of key ACT principles), the attention control videos, and this research design. We will examine treatment differences (within relevant confidence intervals) on outcomes (e.g., depression severity). We will examine change in potential mechanisms, i.e., ACT-consistent coping strategies derived from key ACT principles.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Butler Hospital is the lead sponsor of 113 studies on the registry; 11 are open to participants now.
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Inclusion Criteria:
Antidepressant Treatment as Usual (aTAU): All participants will receive antidepressant treatment as usual provided by their primary care doctor during the study. Storytelling Video Intervention (sTVi): We will develop a series of 4 videos, each episode approximately 30 minutes long, which will illustrate the key principles of Acceptance and Commitment Therapy. In addition, we will develop an accompanying "personal journal" for participants that includes a brief self-help guide which encourages participants to write about what they learned in the videos and how they will take similar steps in their own lives to cope with depression.
Behavioral: aTAU + sTVi
Antidepressant Treatment as Usual (aTAU): All participants will receive antidepressant treatment as usual provided by their primary care doctor during the study. Attention Control Videos: Control participants will view videos about general mental health and well-being. Specifically, we plan to give participants 4 30-minute videos on topics including nutrition, stress reduction, movement and recreation, and becoming an educated patient. The series comes with an accompanying course guidebook. We will provide videos on the same schedule as sTVi.
Behavioral: aTAU + Attention Control Videos
Antidepressant treatment as usual provided by participants' primary care physician plus narrative communication, video-based intervention for improving depression in primary care patients.
Antidepressant treatment as usual provided by participants' primary care physician plus videos about general mental health and well-being on the same dose and frequency as the experimental intervention.
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
Time frame: 4 weeks
Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: 4 weeks
Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: 4 weeks
WHO-Quality of Life-BREF (WHO-QOL-BREF)
Time frame: 4 weeks
WHO-Disability Assessment Schedule-II (WHO-DAS-II)
Time frame: 4 weeks
Plan to share: No
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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