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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04502186
Other study ID # HUM00176192
Secondary ID K01MH110605
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2020
Est. completion date July 31, 2023

Study information

Verified date September 2023
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to test the effectiveness of a computer-assisted cognitive behavioral therapy for depression among rural adults. The intervention, called Raising Our Spirits Together (ROST), was developed via a community-based participatory approach and will be delivered in small groups, facilitated by local pastors. Groups will be held virtually, or in-person at two churches in rural Michigan. Eighty-four individuals will be recruited from Hillsdale, Michigan, to test the effect of ROST on depressive symptoms, compared to an Enhanced Control Condition (ECC).


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date July 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Must live in Hillsdale, Lenawee, Jackson, or Calhoun County, Michigan - Positive screen for at least mild depressive symptoms based on the the Patient Health Questionnaire-9 (PHQ-9>=5) Exclusion Criteria: - Non-English speaking - Currently receiving cognitive behavioral therapy (CBT) for depression - Ever completed a course of cognitive behavioral therapy (CBT; >=8 sessions) - Diagnosis of a psychotic disorder - Current use of opiates or freebase cocaine - Prominent suicidal/homicidal ideation with imminent risk.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Raising Our Spirits Together
Raising Our Spirits Together (ROST) is an 8-session computer-assisted cognitive behavioral therapy for depression. Core CBT content, including behavioral activation, cognitive restructuring, and problem solving, are delivered via the computer-assisted platform using video and text-based elements. The computer-assisted intervention is complemented by a workbook that includes in-session exercises as well as homework/action plans. ROST is delivered weekly, either virtually or in-person at a local church, and facilitated by a local pastor.
Other:
Enhanced Control Condition
The Enhanced Control Condition intervention consists of providing participants randomized to this condition with a self-help book for depression (The Depression Helpbook; Katon et al, 2008) that is widely used and found to be beneficial, a local resource guide, and referrals.

Locations

Country Name City State
United States Trinity Lutheran Church Hillsdale Michigan
United States Jonesville First Presbyterian Church Jonesville Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in self-report measure of depressive symptoms Participants will self report depressive symptoms utilizing the Patient Health Questionnaire-9 (PHQ-9; range 0-27 with higher scores indicating worse outcome) Outcome will be assessed at baseline, immediately post-treatment, and 12-weeks post-treatment
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