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Storytelling Video Intervention for Depressed Primary Care Patients - Pilot Trial

Narrative Intervention to Disseminate ACT for Depression in Primary Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02311725
Acronym
sTVi-RCT
Enrollment
40
Registered
2014-12-08
Start date
2017-05-01
Completion date
2019-03-01
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

narrative communication, depression, antidepressant augmentation, primary care

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALaTAU + sTVi

Antidepressant treatment as usual provided by participants' primary care physician plus narrative communication, video-based intervention for improving depression in primary care patients.

BEHAVIORALaTAU + Attention Control Videos

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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Butler Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Meets DSM-5 criteria for current or lifetime major depressive disorder. 2. No Lifetime diagnosis of bipolar disorder, schizophrenia, or chronic psychotic condition. 3. No current hazardous illicit drug or alcohol use. 4. No suicidal ideation or behavior requiring immediate attention. 5. Depression symptom severity: a Quick Inventory of Depressive Symptoms (QIDS) score \>11. 6. Taking an antidepressant medication for at least 6 weeks; prescribed by their primary care provider. 7. Not in psychotherapy during the study period. 8. Have a PCP at our enrollment site. 9. If pregnant, less than 24 weeks gestation. 10. English speaking. 11. Aged 18 or older.

Design outcomes

Primary

MeasureTime frame
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)4 weeks

Secondary

MeasureTime frame
Client Satisfaction Questionnaire-8 (CSQ-8)4 weeks
Acceptance and Action Questionnaire-II (AAQ-II)4 weeks
WHO-Quality of Life-BREF (WHO-QOL-BREF)4 weeks
WHO-Disability Assessment Schedule-II (WHO-DAS-II)4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026