Thrive, a Computerized Cognitive Behavior Therapy Program to Treat Depression

Depressive Symptoms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03244878
• Other study ID #: MS033017-FC
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: August 2018
• Source: Montana State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 464
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Thrive
A interactive computerized program using structured content of cognitive behavior therapy

Locations

Country	Name	City	State
United States	Montana State University	Bozeman	Montana

Sponsors (1)

Lead Sponsor	Collaborator
Montana State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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