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OpenTrials
Completed

NCT Number: NCT03244878

Thrive, a Computerized Cognitive Behavior Therapy Program to Treat Depression

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montana State University

Bozeman, Montana, 59717, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thrive

Behavioral

A interactive computerized program using structured content of cognitive behavior therapy

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Montana State University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 10, 2017
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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