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

Narrative Intervention to Disseminate ACT for Depression in Primary Care

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).

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Storytelling Video Intervention (sTVi)

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
      • Family Care Center of Memorial Hospital
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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. 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.

Behavioral: Storytelling Video Intervention (sTVi); Narrative communication, video-based intervention for depressed primary care patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Client Satisfaction Questionnaire-8 (CSQ-8)	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Quick Inventory of Depressive Symptomatology-Clinician Rating (QIDS-C)	4 weeks
Acceptance and Action Questionnaire-II (AAQ-II)	4 week

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: December 3, 2014
• First Submitted That Met QC Criteria: December 3, 2014
• First Posted (Estimate): December 5, 2014

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: depression; primary care; narrative communication; treatment development
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: sTVi-1; R34MH103568 (U.S. NIH Grant/Contract)