Digital Cognitive Behavior Therapy Program for Suicide Prevention (TM2)

August 31, 2020 updated by: Mark B. Schure, Ph.D., Montana State University

Thrive-Montana: A Computerized Cognitive Behavior Therapy (cCBT) Program to Reduce Depression, Anxiety, Suicidal Ideation and Behaviors for Rural Montanans

This study evaluates the efficacy of Thrive, a computerized cognitive behavior therapy program, to reduce depression and anxiety symptoms and to reduce suicidal thinking among adults. The first 450 participants will participate in a randomized waitlist controlled trial. The remaining 550 participants will be provided the program immediately upon enrolling

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The efficacy of Thrive has been studied among patient and community populations and has shown to effectively reduce depression and anxiety symptoms among adults with moderate to severe depression symptoms at baseline.

This study will examine whether Thrive can also reduce suicidal thinking for persons exhibiting at least moderate depression symptoms. The first phase of the study will implement a randomized waitlist controlled trial. The second phase of the study will examine the effects in a open trial. Outcome assessments will occur at baseline, 4- and 8-weeks (12- and 16-weeks for the waitlist group) with a 6-month follow-up assessment for all participants.

Study Type

Interventional

Enrollment (Actual)

725

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Bozeman, Montana, United States, 59717-2940
        • Montana State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Montana resident
  • 18+ years old
  • Have regular access to broadband internet
  • PHQ-9 score greater than 4

Exclusion Criteria:

  • No Montana residency
  • < 18 years old
  • No broadband internet access
  • PHQ-9 score less than 5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thrive Intervention
Online cognitive behavior therapy program
Behavioral: Thrive
Computerized Cognitive Behavior Therapy program
Other Names:
  • Thrive-Montana
No Intervention: Waitlist Control
Wait 8 weeks before receiving program access

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concise Health Risk Tracking
Time Frame: 2 Weeks
Suicidal Thinking; Score range 7 (better) - 35(worse)
2 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder Scale-7
Time Frame: 2 Weeks
Anxiety symptoms; Score range 0 (better) to 21 (worse)
2 Weeks
Work and Social Adjustment Scale
Time Frame: 1 Year
Functioning; Score range 0(better) - 40(worse)
1 Year
Connor-Davidson Resilience Scale - Abbreviated Version
Time Frame: 1 month
Resilience; score range 0 (worse) - 40(better)
1 month
Patient Health Questionnaire-9
Time Frame: 2 Weeks
Depression; Score range 0(better) - 27(worse)
2 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montana State University

Collaborators

Montana Department of Public Health and Human Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2018

Primary Completion (Actual)

April 8, 2020

Study Completion (Actual)

April 8, 2020

Study Registration Dates

First Submitted

June 29, 2018

First Submitted That Met QC Criteria

July 11, 2018

First Posted (Actual)

July 23, 2018

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSchure

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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