Digital Cognitive Behavior Therapy Program for Suicide Prevention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Suicidal Ideation, Depression, Anxiety

Intervention / Treatment
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* Behavioral: Thrive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized waitlist controlled trial (first ?? participants) Open trial (following ?? participants)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thrive Intervention<br>Online cognitive behavior therapy program | Behavioral: Thrive<br>* Computerized Cognitive Behavior Therapy program<br>* Other names: Thrive-Montana;|
| No Intervention: Waitlist Control<br>Wait 8 weeks before receiving program access | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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