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Completed

NCT Number: NCT03595254

Digital Cognitive Behavior Therapy Program for Suicide Prevention

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

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Key information

Conditions

Suicidal Ideation Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Self-Injurious Behavior Suicide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montana State University

Bozeman, Montana, 59717-2940, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thrive

Behavioral

Computerized Cognitive Behavior Therapy program

Other names: Thrive-Montana

Primary outcomes

  1. Concise Health Risk Tracking

    Time frame: 2 Weeks

    Suicidal Thinking; Score range 7 (better) - 35(worse)

Secondary outcomes

  1. Generalized Anxiety Disorder Scale-7

    Time frame: 2 Weeks

    Anxiety symptoms; Score range 0 (better) to 21 (worse)

  2. Work and Social Adjustment Scale

    Time frame: 1 Year

    Functioning; Score range 0(better) - 40(worse)

  3. Connor-Davidson Resilience Scale - Abbreviated Version

    Time frame: 1 month

    Resilience; score range 0 (worse) - 40(better)

  4. Patient Health Questionnaire-9

    Time frame: 2 Weeks

    Depression; Score range 0(better) - 27(worse)

Sponsors and collaborators

Lead sponsor

Montana State University

Other

Collaborators

  • Montana Department of Public Health and Human Services

Registry information

Official study title

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

Acronym: TM2

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 23, 2018
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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