Thrive, a Computerized Cognitive Behavior Therapy Program to Treat Depression

Not Applicable

Completed

• Conditions: Depressive Symptoms
• Interventions: Behavioral: Thrive

• Registration Number: NCT03244878
• Lead Sponsor: Montana State University

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 Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-10
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-12
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 464

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention - Thrive program	Thrive	Participants will receive access to the Thrive program for 8 weeks

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9	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 Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder-7	2 weeks	Self-reported measure of anxiety symptoms with a scale from 0 to 3 (not at all to nearly every day)
Work and Social Adjustment Scale	1 year	Self-reported measure of a chronic condition's impact on daily work and social life with a scale of 0 to 8 (none to very severe)
Connor-Davidson Resilience Scale	1 month	Self-reported assessment of personal resilience with a scale of 0 to 3 (not true at all to often true)

Trial Locations

Locations (1)

Montana State University; 🇺🇸 Bozeman, Montana, United States