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Digital Cognitive Behavior Therapy Program for Suicide Prevention (TM2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03595254
Recruitment Status : Completed
First Posted : July 23, 2018
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
Montana Department of Public Health and Human Services
Information provided by (Responsible Party):
Mark B. Schure, Ph.D., Montana State University

Study Description
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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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 725 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized waitlist controlled trial (first ?? participants) Open trial (following ?? 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
Actual Study Start Date : November 16, 2018
Actual Primary Completion Date : April 8, 2020
Actual Study Completion Date : April 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Suicide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Thrive Intervention
Online cognitive behavior therapy program
 Behavioral: Thrive
Computerized Cognitive Behavior Therapy program
Other Name: Thrive-Montana
No Intervention: Waitlist Control
Wait 8 weeks before receiving program access


Outcome Measures
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Primary Outcome Measures :
  1. Concise Health Risk Tracking [ Time Frame: 2 Weeks ]
    Suicidal Thinking; Score range 7 (better) - 35(worse)


Secondary Outcome Measures :
  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)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Contacts and Locations
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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
Bozeman, Montana, United States, 59717-2940
Sponsors and Collaborators
Montana State University
Montana Department of Public Health and Human Services
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Mark B. Schure, Ph.D., Assistant Professor, Montana State University
ClinicalTrials.gov Identifier: NCT03595254    
Other Study ID Numbers: MSchure
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
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
Suicidal Ideation
Behavioral Symptoms
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