Digital Cognitive Behavior Therapy Program for Suicide Prevention

Depression Clinical Trial

— TM2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595254
• Other study ID #: MSchure
• Status: Completed
• Phase: N/A
• Start date: November 16, 2018
• Est. completion date: April 8, 2020

Study information

• Verified date: August 2020
• Source: Montana State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 725
• Est. completion date: April 8, 2020
• Est. primary completion date: April 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Suicidal Ideation

Intervention

Behavioral:
• Thrive
Computerized Cognitive Behavior Therapy program

Locations

Country	Name	City	State
United States	Montana State University	Bozeman	Montana

Sponsors (2)

Lead Sponsor	Collaborator
Montana State University	Montana Department of Public Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concise Health Risk Tracking	Suicidal Thinking; Score range 7 (better) - 35(worse)	2 Weeks
Secondary	Generalized Anxiety Disorder Scale-7	Anxiety symptoms; Score range 0 (better) to 21 (worse)	2 Weeks
Secondary	Work and Social Adjustment Scale	Functioning; Score range 0(better) - 40(worse)	1 Year
Secondary	Connor-Davidson Resilience Scale - Abbreviated Version	Resilience; score range 0 (worse) - 40(better)	1 month
Secondary	Patient Health Questionnaire-9	Depression; Score range 0(better) - 27(worse)	2 Weeks