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Completed

NCT Number: NCT02311725

Storytelling Video Intervention for Depressed Primary Care Patients - Pilot Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02916, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

aTAU + sTVi

Behavioral

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

Behavioral

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 outcomes

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

    Time frame: 4 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Narrative Intervention to Disseminate ACT for Depression in Primary Care

Acronym: sTVi-RCT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 8, 2014
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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