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Thrive, a Computerized Cognitive Behavior Therapy Program to Treat Depression

Primary Purpose

Depressive Symptoms

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 Depressive Symptoms focused on measuring Cognitive Behavior Therapy

Eligibility Criteria

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

Inclusion Criteria:

  • Aged 18 years or older
  • Baseline PHQ-9 score of 5 or greater
  • Montana resident
  • Regular access to broadband internet (streaming capability)

Exclusion Criteria:

  • No broadband internet access
  • Aged 17 years or younger
  • Does not have Montana residency
  • Baseline PHQ-9 score of < 5

Sites / Locations

  • Montana State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention - Thrive program

Wait-list Control

Arm Description

Participants will receive access to the Thrive program for 8 weeks

Participants will have no access to the Thrive program for 8 weeks upon enrollment. They will receive a link to the NIMH website to read about information on depression.

Outcomes

Primary Outcome Measures

Patient Health Questionnaire-9
Clinical measure of depressive symptom severity. Self-reported with a score range from 0 to 3 (not at all to nearly every day)

Secondary Outcome Measures

Generalized Anxiety Disorder-7
Self-reported measure of anxiety symptoms with a scale from 0 to 3 (not at all to nearly every day)
Work and Social Adjustment Scale
Self-reported measure of a chronic condition's impact on daily work and social life with a scale of 0 to 8 (none to very severe)
Connor-Davidson Resilience Scale
Self-reported assessment of personal resilience with a scale of 0 to 3 (not true at all to often true)

Full Information

First Posted
August 3, 2017
Last Updated
August 12, 2018
Sponsor
Montana State University
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1. Study Identification

Unique Protocol Identification Number
NCT03244878
Brief Title
Thrive, a Computerized Cognitive Behavior Therapy Program to Treat Depression
Official Title
Randomized Controlled Trial of a Culturally-adapted Version of Thrive, a Computerized Cognitive Behavior Therapy (cCBT) Program to Treat Depressive Symptoms, Syndromes, and Disorders Among Rural Montanans
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montana State University

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 a culturally-modified version of Thrive, a computerized Cognitive Behavior Therapy program to treat depressive symptoms, syndromes, and disorders among rural Montanans. Study participants will be randomized to either a wait-list treatment as usual or the Thrive program. After 8 weeks, the wait-list group will then receive Thrive. The primary assessment measure is the Patient Health Questionnaire-9.
Detailed Description
Montana ranks high among states on mental health disorder prevalence and low on access to mental health care. It has the highest suicide rate in the nation. Of Montana's 56 counties, 10 are classified as rural and 45 as frontier, accentuating distance challenges in accessing care. New treatment delivery modalities are needed to complement, supplement and augment traditional mental health care. With increase in access to the Internet, computer-administered Cognitive Behavior Therapy (cCBT) programs have emerged as viable approaches to effective treatment of depression. Thrive is an interactive cCBT program with a heavy emphasis on video rather than text content that appears to improve participant engagement, a shortcoming seen in prior cCBT programs. The goal of this project is to conduct a randomized wait-list controlled of Thrive to determine its effectiveness in reducing depressive symptom severity among Montanans, many of whom have few or no other options for mental health treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
Cognitive Behavior Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to either the wait-list controlled group or intervention group. Intervention period is 8 weeks. Data collection occurs at baseline, 4 weeks, and 8 weeks, with longer-term follow-up assessments.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
464 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention - Thrive program
Arm Type
Experimental
Arm Description
Participants will receive access to the Thrive program for 8 weeks
Arm Title
Wait-list Control
Arm Type
No Intervention
Arm Description
Participants will have no access to the Thrive program for 8 weeks upon enrollment. They will receive a link to the NIMH website to read about information on depression.
Intervention Type
Behavioral
Intervention Name(s)
Thrive
Intervention Description
A interactive computerized program using structured content of cognitive behavior therapy
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9
Description
Clinical measure of depressive symptom severity. Self-reported with a score range from 0 to 3 (not at all to nearly every day)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Generalized Anxiety Disorder-7
Description
Self-reported measure of anxiety symptoms with a scale from 0 to 3 (not at all to nearly every day)
Time Frame
2 weeks
Title
Work and Social Adjustment Scale
Description
Self-reported measure of a chronic condition's impact on daily work and social life with a scale of 0 to 8 (none to very severe)
Time Frame
1 year
Title
Connor-Davidson Resilience Scale
Description
Self-reported assessment of personal resilience with a scale of 0 to 3 (not true at all to often true)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18 years or older Baseline PHQ-9 score of 5 or greater Montana resident Regular access to broadband internet (streaming capability) Exclusion Criteria: No broadband internet access Aged 17 years or younger Does not have Montana residency Baseline PHQ-9 score of < 5
Facility Information:
Facility Name
Montana State University
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59717
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33006561
Citation
Schure M, McCrory B, Tuchscherer Franklin K, Greist J, Weissman RS. Twelve-Month Follow-Up to a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention for Rural Adults With Depression Symptoms: Single-Arm Longitudinal Study. J Med Internet Res. 2020 Oct 2;22(10):e21336. doi: 10.2196/21336. Erratum In: J Med Internet Res. 2020 Oct 23;22(10):e25146.
Results Reference
derived
PubMed Identifier
31738173
Citation
Schure MB, Lindow JC, Greist JH, Nakonezny PA, Bailey SJ, Bryan WL, Byerly MJ. Use of a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention in a Community Population of Adults With Depression Symptoms: Randomized Controlled Trial. J Med Internet Res. 2019 Nov 18;21(11):e14754. doi: 10.2196/14754.
Results Reference
derived

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Thrive, a Computerized Cognitive Behavior Therapy Program to Treat Depression

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