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Thrive, a Computerized Cognitive Behavior Therapy Program to Treat Depression

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ClinicalTrials.gov Identifier: NCT03244878
Recruitment Status : Completed
First Posted : August 10, 2017
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Mark B. Schure, Ph.D., Montana State University

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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Behavioral: Thrive Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 464 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention - Thrive program
Participants will receive access to the Thrive program for 8 weeks
Behavioral: Thrive
A interactive computerized program using structured content of cognitive behavior therapy

No Intervention: Wait-list Control
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.



Primary Outcome Measures :
  1. Patient Health Questionnaire-9 [ Time Frame: 2 weeks ]
    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 :
  1. Generalized Anxiety Disorder-7 [ Time Frame: 2 weeks ]
    Self-reported measure of anxiety symptoms with a scale from 0 to 3 (not at all to nearly every day)

  2. Work and Social Adjustment Scale [ Time Frame: 1 year ]
    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)

  3. Connor-Davidson Resilience Scale [ Time Frame: 1 month ]
    Self-reported assessment of personal resilience with a scale of 0 to 3 (not true at all to often true)



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:

  • 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

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): NCT03244878


Locations
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United States, Montana
Montana State University
Bozeman, Montana, United States, 59717
Sponsors and Collaborators
Montana State University
  Study Documents (Full-Text)

Documents provided by Mark B. Schure, Ph.D., Montana State University:

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Responsible Party: Mark B. Schure, Ph.D., Assistant Professor, Montana State University
ClinicalTrials.gov Identifier: NCT03244878     History of Changes
Other Study ID Numbers: MS033017-FC
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 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

Keywords provided by Mark B. Schure, Ph.D., Montana State University:
Cognitive Behavior Therapy

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
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