Thrive, a Computerized Cognitive Behavior Therapy Program to Treat Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Depressive Symptoms

Intervention / Treatment
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* Behavioral: Thrive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomized to either the wait-list controlled group or intervention group. Intervention period is 8 weeks. Data collection occurs at baseline, 4 weeks, and 8 weeks, with longer-term follow-up assessments.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention - Thrive program<br>Participants will receive access to the Thrive program for 8 weeks | Behavioral: Thrive<br>* A interactive computerized program using structured content of cognitive behavior therapy<br>|
| No Intervention: Wait-list Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 | Clinical measure of depressive symptom severity. Self-reported with a score range from 0 to 3 (not at all to nearly every day) | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalized Anxiety Disorder-7 | Self-reported measure of anxiety symptoms with a scale from 0 to 3 (not at all to nearly every day) | 2 weeks | 
| Work and Social Adjustment Scale | 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) | 1 year | 
| Connor-Davidson Resilience Scale | Self-reported assessment of personal resilience with a scale of 0 to 3 (not true at all to often true) | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavior Therapy