Storytelling Video Intervention for Depressed Primary Care Patients - Open Trial

NCT ID: NCT02309060

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-03-01

Brief Summary

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).

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Storytelling Video Intervention (sTVi)

Intervention Type: BEHAVIORAL

Narrative communication, video-based intervention for depressed primary care patients.

Interventions

Storytelling Video Intervention (sTVi)

Narrative communication, video-based intervention for depressed primary care patients.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lisa Uebelacker

Co-PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa Uebelacker, PhD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital/Brown University

Brandon Gaudiano, PhD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital/Brown University

Locations

Family Care Center of Memorial Hospital

Pawtucket, Rhode Island, United States

Butler Hospital

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 29090593 (View on PubMed)

Other Identifiers

R34MH103568

Identifier Type: NIH

Identifier Source: secondary_id

View Link

sTVi-1

Identifier Type: -

Identifier Source: org_study_id