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Digital Cognitive Behavior Therapy Program for Suicide Prevention (TM2)

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ClinicalTrials.gov Identifier: NCT03595254
Recruitment Status : Not yet recruiting
First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Collaborator:
Montana Department of Public Health and Human Services
Information provided by (Responsible Party):
Mark B. Schure, Ph.D., 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

Condition or disease Intervention/treatment Phase
Suicidal Ideation Depression Anxiety Behavioral: Thrive Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized waitlist controlled trial (first 450 participants) Open trial (following 550 participants)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thrive-Montana: A Computerized Cognitive Behavior Therapy (cCBT) Program to Reduce Depression, Anxiety, Suicidal Ideation and Behaviors for Rural Montanans
Estimated Study Start Date : August 15, 2018
Estimated Primary Completion Date : May 15, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Suicide

Arm Intervention/treatment
Experimental: Thrive Intervention
Online cognitive behavior therapy program
Behavioral: Thrive
Computerized Cognitive Behavior Therapy program
Other Name: Thrive-Montana

Active Comparator: Waitlist Control
Wait 8 weeks before receiving program access
Behavioral: Thrive
Computerized Cognitive Behavior Therapy program
Other Name: Thrive-Montana




Primary Outcome Measures :
  1. Concise Health Risk Tracking [ Time Frame: 2 Weeks ]
    Suicidal Thinking


Secondary Outcome Measures :
  1. Generalized Anxiety Disorder Scale-7 [ Time Frame: 2 Weeks ]
    Anxiety symptoms

  2. Work and Social Adjustment Scale [ Time Frame: 1 Year ]
    Functioning

  3. Connor-Davidson Resilience Scale - Abbreviated Version [ Time Frame: 1 month ]
    Resilience

  4. Patient Health Questionnaire-9 [ Time Frame: 2 Weeks ]
    Depression



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595254


Locations
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United States, Montana
Montana State University Not yet recruiting
Bozeman, Montana, United States, 59717-2940
Contact: Mark B Schure, PhD    406-994-3248    mark.schure@montana.edu   
Contact: Traci Miyakawa    406-994-7696    tracim@montana.edu   
Sponsors and Collaborators
Montana State University
Montana Department of Public Health and Human Services

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Responsible Party: Mark B. Schure, Ph.D., Assistant Professor, Montana State University
ClinicalTrials.gov Identifier: NCT03595254     History of Changes
Other Study ID Numbers: MSchure
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Suicidal Ideation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Suicide
Self-Injurious Behavior
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action