A Systems-Level Intervention for Rural Adults With Depression

NCT ID: NCT04502186

Last Updated: 2025-02-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-20

Study Completion Date

2023-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Raising Our Spirits Together Intervention

Group Type EXPERIMENTAL

Raising Our Spirits Together

Intervention Type BEHAVIORAL

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.

Enhanced Control Condition

Group Type OTHER

Enhanced Control Condition

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Addie Weaver

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Addie Weaver, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Trinity Lutheran Church

Hillsdale, Michigan, United States

Site Status

Jonesville First Presbyterian Church

Jonesville, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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K01MH110605

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00176192

Identifier Type: -

Identifier Source: org_study_id

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