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

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ClinicalTrials.gov Identifier: NCT02311725
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Lisa Uebelacker, Butler Hospital

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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: aTAU + sTVi Behavioral: aTAU + Attention Control Videos Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Narrative Intervention to Disseminate ACT for Depression in Primary Care
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: aTAU + sTVi

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

Active Comparator: aTAU + Attention Control Videos

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 videos about general mental health and well-being on the same dose and frequency as the experimental intervention.




Primary Outcome Measures :
  1. Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Client Satisfaction Questionnaire-8 (CSQ-8) [ Time Frame: 4 weeks ]
  2. Acceptance and Action Questionnaire-II (AAQ-II) [ Time Frame: 4 weeks ]
  3. WHO-Quality of Life-BREF (WHO-QOL-BREF) [ Time Frame: 4 weeks ]
  4. WHO-Disability Assessment Schedule-II (WHO-DAS-II) [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311725


Locations
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United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02916
Sponsors and Collaborators
Butler Hospital
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Lisa Uebelacker, PhD Butler Hospital/Brown University
Principal Investigator: Brandon Gaudiano, PhD Butler Hospital/Brown University
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Responsible Party: Lisa Uebelacker, Co-PI, Butler Hospital
ClinicalTrials.gov Identifier: NCT02311725    
Other Study ID Numbers: sTVi-2
R34MH103568 ( U.S. NIH Grant/Contract )
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa Uebelacker, Butler Hospital:
narrative communication
depression
antidepressant augmentation
primary care
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders