Thrive, a Computerized Cognitive Behavior Therapy Program to Treat Depression
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|ClinicalTrials.gov Identifier: NCT03244878|
Recruitment Status : Completed
First Posted : August 10, 2017
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depressive Symptoms||Behavioral: Thrive||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||464 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Official Title:||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|
|Actual Study Start Date :||May 1, 2017|
|Actual Primary Completion Date :||January 31, 2018|
|Actual Study Completion Date :||January 31, 2018|
Experimental: Intervention - Thrive program
Participants will receive access to the Thrive program for 8 weeks
A interactive computerized program using structured content of cognitive behavior therapy
No Intervention: 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.
- 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)
- Generalized Anxiety Disorder-7 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 month ]Self-reported assessment of personal resilience with a scale of 0 to 3 (not true at all to often true)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244878
|United States, Montana|
|Montana State University|
|Bozeman, Montana, United States, 59717|