Thrive, a Computerized Cognitive Behavior Therapy Program to Treat Depression

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

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.

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms
• Intervention / Treatment: Behavioral: Thrive

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 Type: Interventional
• Enrollment (Actual): 464
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Montana
    • Bozeman, Montana, United States, 59717
      • Montana State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention - Thrive program; Participants will receive access to the Thrive program for 8 weeks	Behavioral: Thrive; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Montana State University

Publications and helpful links

General Publications

• Schure M, McCrory B, Tuchscherer Franklin K, Greist J, Weissman RS. Twelve-Month Follow-Up to a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention for Rural Adults With Depression Symptoms: Single-Arm Longitudinal Study. J Med Internet Res. 2020 Oct 2;22(10):e21336. doi: 10.2196/21336. Erratum In: J Med Internet Res. 2020 Oct 23;22(10):e25146.
• Schure MB, Lindow JC, Greist JH, Nakonezny PA, Bailey SJ, Bryan WL, Byerly MJ. Use of a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention in a Community Population of Adults With Depression Symptoms: Randomized Controlled Trial. J Med Internet Res. 2019 Nov 18;21(11):e14754. doi: 10.2196/14754.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 12, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Cognitive Behavior Therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: MS033017-FC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No