Randomized Controlled Trial of a Culturally-adapted Version of Thrive, a Computerized Cognitive Behavior Therapy (cCBT) Program to Treat Depressive Symptoms, Syndromes, and Disorders Among Rural Montanans
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Montana State University
- Enrollment
- 464
- Locations
- 1
- Primary Endpoint
- Patient Health Questionnaire-9
Study Overview
Brief Summary
This study evaluates a culturally-modified version of Thrive, a computerized Cognitive Behavior Therapy program to treat depressive symptoms, syndromes, and disorders among rural Montanans. Study participants will be randomized to either a wait-list treatment as usual or the Thrive program. After 8 weeks, the wait-list group will then receive Thrive. The primary assessment measure is the Patient Health Questionnaire-9.
Detailed Description
Montana ranks high among states on mental health disorder prevalence and low on access to mental health care. It has the highest suicide rate in the nation. Of Montana's 56 counties, 10 are classified as rural and 45 as frontier, accentuating distance challenges in accessing care. New treatment delivery modalities are needed to complement, supplement and augment traditional mental health care. With increase in access to the Internet, computer-administered Cognitive Behavior Therapy (cCBT) programs have emerged as viable approaches to effective treatment of depression.
Thrive is an interactive cCBT program with a heavy emphasis on video rather than text content that appears to improve participant engagement, a shortcoming seen in prior cCBT programs.
The goal of this project is to conduct a randomized wait-list controlled of Thrive to determine its effectiveness in reducing depressive symptom severity among Montanans, many of whom have few or no other options for mental health treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 18 years or older
- •Baseline PHQ-9 score of 5 or greater
- •Montana resident
- •Regular access to broadband internet (streaming capability)
Exclusion Criteria
- •No broadband internet access
- •Aged 17 years or younger
- •Does not have Montana residency
- •Baseline PHQ-9 score of < 5
Arms & Interventions
Intervention - Thrive program
Participants will receive access to the Thrive program for 8 weeks
Intervention: Thrive (Behavioral)
Wait-list Control
Participants will have no access to the Thrive program for 8 weeks upon enrollment. They will receive a link to the NIMH website to read about information on depression.
Outcomes
Primary Outcomes
Patient Health Questionnaire-9
Time Frame: 2 weeks
Clinical measure of depressive symptom severity. Self-reported with a score range from 0 to 3 (not at all to nearly every day)
Secondary Outcomes
- Generalized Anxiety Disorder-7(2 weeks)
- Work and Social Adjustment Scale(1 year)
- Connor-Davidson Resilience Scale(1 month)
Investigators
Mark B. Schure, Ph.D.
Assistant Professor
Montana State University