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Storytelling Video Intervention for Depressed Primary Care Patients - Pilot Trial (sTVi-RCT)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
aTAU + sTVi
aTAU + Attention Control Videos
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring narrative communication, depression, antidepressant augmentation, primary care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

aTAU + sTVi

aTAU + Attention Control Videos

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)

Secondary Outcome Measures

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

Full Information

First Posted
December 3, 2014
Last Updated
June 14, 2022
Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02311725
Brief Title
Storytelling Video Intervention for Depressed Primary Care Patients - Pilot Trial
Acronym
sTVi-RCT
Official Title
Narrative Intervention to Disseminate ACT for Depression in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
narrative communication, depression, antidepressant augmentation, primary care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aTAU + sTVi
Arm Type
Experimental
Arm Description
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.
Arm Title
aTAU + Attention Control Videos
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
aTAU + sTVi
Intervention Description
Antidepressant treatment as usual provided by participants' primary care physician plus narrative communication, video-based intervention for improving depression in primary care patients.
Intervention Type
Behavioral
Intervention Name(s)
aTAU + Attention Control Videos
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Client Satisfaction Questionnaire-8 (CSQ-8)
Time Frame
4 weeks
Title
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame
4 weeks
Title
WHO-Quality of Life-BREF (WHO-QOL-BREF)
Time Frame
4 weeks
Title
WHO-Disability Assessment Schedule-II (WHO-DAS-II)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets DSM-5 criteria for current or lifetime major depressive disorder. No Lifetime diagnosis of bipolar disorder, schizophrenia, or chronic psychotic condition. No current hazardous illicit drug or alcohol use. No suicidal ideation or behavior requiring immediate attention. Depression symptom severity: a Quick Inventory of Depressive Symptoms (QIDS) score >11. Taking an antidepressant medication for at least 6 weeks; prescribed by their primary care provider. Not in psychotherapy during the study period. Have a PCP at our enrollment site. If pregnant, less than 24 weeks gestation. English speaking. Aged 18 or older.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Uebelacker, PhD
Organizational Affiliation
Butler Hospital/Brown University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brandon Gaudiano, PhD
Organizational Affiliation
Butler Hospital/Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02916
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32087610
Citation
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. doi: 10.1002/cpp.2436. Epub 2020 Feb 28.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322697/
Description
Pilot randomized controlled trial of a video self-help intervention for depression based on acceptance and commitment therapy: Feasibility and acceptability

Learn more about this trial

Storytelling Video Intervention for Depressed Primary Care Patients - Pilot Trial

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