Storytelling Video Intervention for Depressed Primary Care Patients - Pilot Trial

NCT02311725 | Completed

• 2 other identifiers: sTVi-2R34MH103568
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

narrative communication; depression; antidepressant augmentation; primary care

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (4)

• 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 Arms (2)

aTAU + sTVi

EXPERIMENTAL

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

aTAU + Attention Control Videos

ACTIVE COMPARATOR

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

Interventions

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 + sTVi

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.

aTAU + Attention Control Videos

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02916, United States

Location

Related Publications (1)

• 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.

  PMID: 32087610 BACKGROUND

Related Links

• Pilot randomized controlled trial of a video self-help intervention for depression based on acceptance and commitment therapy: Feasibility and acceptability

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Lisa Uebelacker, PhD

  Butler Hospital/Brown University

  PRINCIPAL INVESTIGATOR

• Brandon Gaudiano, PhD

  Butler Hospital/Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-PI

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 8, 2014
• Study Start: May 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: December 4, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)