Storytelling Video Intervention for Depressed Primary Care Patients - Pilot Trial

Major Depressive Disorder Clinical Trial

— sTVi-RCT  

Official title:

Narrative Intervention to Disseminate ACT for Depression in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02311725
• Other study ID #: sTVi-2
• Secondary ID: R34MH103568
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: June 2022
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gaudiano BA, Davis CH, Miller IW, Uebelacker L. Pilot randomized controlled trial of a video self-help intervention for depression based on acceptance and commitment therapy: Feasibility and acceptability. Clin Psychol Psychother. 2020 May;27(3):396-407. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)		4 weeks
Secondary	Client Satisfaction Questionnaire-8 (CSQ-8)		4 weeks
Secondary	Acceptance and Action Questionnaire-II (AAQ-II)		4 weeks
Secondary	WHO-Quality of Life-BREF (WHO-QOL-BREF)		4 weeks
Secondary	WHO-Disability Assessment Schedule-II (WHO-DAS-II)		4 weeks

External Links

•   Pilot randomized controlled trial of a video self-help intervention for depression based on acceptance and commitment therapy: Feasibility and acceptability