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Clinical Trials/NCT02311725
NCT02311725
Completed
Not Applicable

Narrative Intervention to Disseminate ACT for Depression in Primary Care

Butler Hospital1 site in 1 country40 target enrollmentMay 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
Butler Hospital
Enrollment
40
Locations
1
Primary Endpoint
Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2017
End Date
March 1, 2019
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lisa Uebelacker

Co-PI

Butler Hospital

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 \>
  • 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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 4 weeks

Secondary Outcomes

  • 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)

Study Sites (1)

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