Clinical trial NCT02311725: Storytelling Video Intervention for Depressed Primary Care Patients - Pilot Trial
Official title: Narrative Intervention to Disseminate ACT for Depression in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: narrative communication
depression
antidepressant augmentation
primary care
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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. 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.

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.

Primary outcomes:
measure: Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C)
timeFrame: 4 weeks
Secondary outcomes:
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: 4 weeks
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: 4 weeks
measure: WHO-Quality of Life-BREF (WHO-QOL-BREF)
timeFrame: 4 weeks
measure: WHO-Disability Assessment Schedule-II (WHO-DAS-II)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital/Brown University
name: Lisa Uebelacker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Butler Hospital/Brown University
name: Brandon Gaudiano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.