Storytelling Video Intervention for Depressed Primary Care Patients - Open Trial

Major Depressive Disorder Clinical Trial

— sTVi-Open  

Official title:

Narrative Intervention to Disseminate ACT for Depression in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309060
• Other study ID #: sTVi-1
• Secondary ID: R34MH103568
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: June 2019
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 1, 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Family Care Center of Memorial Hospital	Pawtucket	Rhode Island
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.1177/01454455177389 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Client Satisfaction Questionnaire-8 (CSQ-8)		4 weeks
Secondary	Quick Inventory of Depressive Symptomatology-Clinician Rating (QIDS-C)		4 weeks
Secondary	Acceptance and Action Questionnaire-II (AAQ-II)		4 week