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Digital Cognitive Behavior Therapy Program for Suicide Prevention (TM2)

Primary Purpose

Suicidal Ideation, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thrive
Sponsored by
Montana State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Montana State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Thrive Intervention

Waitlist Control

Arm Description

Online cognitive behavior therapy program

Wait 8 weeks before receiving program access

Outcomes

Primary Outcome Measures

Concise Health Risk Tracking
Suicidal Thinking; Score range 7 (better) - 35(worse)

Secondary Outcome Measures

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

Full Information

First Posted
June 29, 2018
Last Updated
August 31, 2020
Sponsor
Montana State University
Collaborators
Montana Department of Public Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT03595254
Brief Title
Digital Cognitive Behavior Therapy Program for Suicide Prevention
Acronym
TM2
Official Title
Thrive-Montana: A Computerized Cognitive Behavior Therapy (cCBT) Program to Reduce Depression, Anxiety, Suicidal Ideation and Behaviors for Rural Montanans
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 16, 2018 (Actual)
Primary Completion Date
April 8, 2020 (Actual)
Study Completion Date
April 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montana State University
Collaborators
Montana Department of Public Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Depression, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized waitlist controlled trial (first ?? participants) Open trial (following ?? participants)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
725 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thrive Intervention
Arm Type
Experimental
Arm Description
Online cognitive behavior therapy program
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Wait 8 weeks before receiving program access
Intervention Type
Behavioral
Intervention Name(s)
Thrive
Other Intervention Name(s)
Thrive-Montana
Intervention Description
Computerized Cognitive Behavior Therapy program
Primary Outcome Measure Information:
Title
Concise Health Risk Tracking
Description
Suicidal Thinking; Score range 7 (better) - 35(worse)
Time Frame
2 Weeks
Secondary Outcome Measure Information:
Title
Generalized Anxiety Disorder Scale-7
Description
Anxiety symptoms; Score range 0 (better) to 21 (worse)
Time Frame
2 Weeks
Title
Work and Social Adjustment Scale
Description
Functioning; Score range 0(better) - 40(worse)
Time Frame
1 Year
Title
Connor-Davidson Resilience Scale - Abbreviated Version
Description
Resilience; score range 0 (worse) - 40(better)
Time Frame
1 month
Title
Patient Health Questionnaire-9
Description
Depression; Score range 0(better) - 27(worse)
Time Frame
2 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Montana State University
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59717-2940
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Digital Cognitive Behavior Therapy Program for Suicide Prevention

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