Digital Cognitive Behavior Therapy Program for Suicide Prevention

Not Applicable

Completed

• Conditions: Suicidal Ideation; Depression; Anxiety
• Interventions: Behavioral: Thrive

• Registration Number: NCT03595254
• Lead Sponsor: Montana State University

Brief 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

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 Timeline

• Study First Submitted: 2018-06-29
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-23
• Study Start: 2018-11-16
• Primary Completion: 2020-04-08
• Study Completion: 2020-04-08
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 725

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thrive Intervention	Thrive	Online cognitive behavior therapy program

Primary Outcome Measures

Name	Time	Method
Concise Health Risk Tracking	2 Weeks	Suicidal Thinking; Score range 7 (better) - 35(worse)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Montana State University; 🇺🇸 Bozeman, Montana, United States