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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - Thrive program | Experimental | Participants will receive access to the Thrive program for 8 weeks |
|
| Wait-list Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrive | Behavioral | A interactive computerized program using structured content of cognitive behavior therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montana State University | Bozeman | Montana | 59717 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33006561 | Derived | 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. | |
| 31738173 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2017 | Oct 29, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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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.
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| 1 year |
| 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 |
| 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. |
| D006573 |
| Heterocyclic Compounds, 1-Ring |