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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03244878
Other study ID # MS033017-FC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date January 31, 2018

Study information

Verified date August 2018
Source Montana State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 464
Est. completion date January 31, 2018
Est. primary completion date January 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Thrive
A interactive computerized program using structured content of cognitive behavior therapy

Locations

Country Name City State
United States Montana State University Bozeman Montana

Sponsors (1)

Lead Sponsor Collaborator
Montana State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 2 weeks
Secondary Generalized Anxiety Disorder-7 Self-reported measure of anxiety symptoms with a scale from 0 to 3 (not at all to nearly every day) 2 weeks
Secondary 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) 1 year
Secondary Connor-Davidson Resilience Scale Self-reported assessment of personal resilience with a scale of 0 to 3 (not true at all to often true) 1 month
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