Clinical trial NCT03244878: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Keywords: Cognitive Behavior Therapy
Lead sponsor: Montana State University
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: 2 weeks
Secondary outcomes:
measure: Generalized Anxiety Disorder-7
timeFrame: 2 weeks
measure: Work and Social Adjustment Scale
timeFrame: 1 year
measure: Connor-Davidson Resilience Scale
timeFrame: 1 month
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: Montana State University
state: Montana
Study officials:
References:
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.
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.