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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Storytelling Video Intervention (sTVi)
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, primary care, treatment development

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

  • Family Care Center of Memorial Hospital
  • Butler Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Storytelling Video Intervention (sTVi)

Arm Description

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. We will add a short, non-narrative, epilogue at the end of each of the 4 episodes that summarizes key messages and provides information on identifying signs of depression and suggestions for efficacious treatments. 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.

Outcomes

Primary Outcome Measures

Client Satisfaction Questionnaire-8 (CSQ-8)

Secondary Outcome Measures

Quick Inventory of Depressive Symptomatology-Clinician Rating (QIDS-C)
Acceptance and Action Questionnaire-II (AAQ-II)

Full Information

First Posted
December 3, 2014
Last Updated
June 24, 2019
Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02309060
Brief Title
Storytelling Video Intervention for Depressed Primary Care Patients - Open Trial
Acronym
sTVi-Open
Official Title
Narrative Intervention to Disseminate ACT for Depression in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
March 1, 2017 (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

Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall aim of this program of research is to develop a collaborative narrative intervention for patients with depression being treated in primary care. The purpose of the proposed project is to establish the feasibility, acceptability, and preliminary effects of our newly developed narrative intervention on depression. To achieve the specific aims, the investigators will conduct an open trial to further develop and refine the intervention (n = 10).
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. ACT is an empirically supported therapy for depression. 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 aim is to conduct a small open trial (n = 10) of antidepressant medication treatment as usual + sTVi. Assessments will occur at baseline and 4 weeks (post-treatment). We will examine the feasibility and acceptability of sTVi (e.g., uptake and completion of sTVi, engagement with videos, and understanding of key ACT principles) and of this research design. We will examine treatment effects (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, primary care, treatment development

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Storytelling Video Intervention (sTVi)
Arm Type
Experimental
Arm Description
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. We will add a short, non-narrative, epilogue at the end of each of the 4 episodes that summarizes key messages and provides information on identifying signs of depression and suggestions for efficacious treatments. 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.
Intervention Type
Behavioral
Intervention Name(s)
Storytelling Video Intervention (sTVi)
Intervention Description
Narrative communication, video-based intervention for depressed primary care patients.
Primary Outcome Measure Information:
Title
Client Satisfaction Questionnaire-8 (CSQ-8)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology-Clinician Rating (QIDS-C)
Time Frame
4 weeks
Title
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame
4 week

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
Family Care Center of Memorial Hospital
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29090593
Citation
Gaudiano BA, Davis CH, Miller IW, Uebelacker LA. Development of a Storytelling Video Self-Help Intervention Based on Acceptance and Commitment Therapy for Major Depression: Open Trial Results. Behav Modif. 2019 Jan;43(1):56-81. doi: 10.1177/0145445517738932. Epub 2017 Nov 1.
Results Reference
result

Learn more about this trial

Storytelling Video Intervention for Depressed Primary Care Patients - Open Trial

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