Major Depressive Disorder Clinical Trial
— sTVi-RCTOfficial title:
Narrative Intervention to Disseminate ACT for Depression in Primary Care
Verified date | June 2022 |
Source | Butler Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 1, 2019 |
Est. primary completion date | March 1, 2019 |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Butler Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Butler Hospital | National Institute of Mental Health (NIMH) |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quick Inventory of Depressive Symptomatology - Clinician Rating (QIDS-C) | 4 weeks | ||
Secondary | Client Satisfaction Questionnaire-8 (CSQ-8) | 4 weeks | ||
Secondary | Acceptance and Action Questionnaire-II (AAQ-II) | 4 weeks | ||
Secondary | WHO-Quality of Life-BREF (WHO-QOL-BREF) | 4 weeks | ||
Secondary | WHO-Disability Assessment Schedule-II (WHO-DAS-II) | 4 weeks |
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