A Systems-Level Intervention for Rural Adults With Depression

NCT04502186 | Completed Results DMC

• 2 other identifiers: HUM00176192K01MH110605
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 (up to 8 weeks), and 12-weeks post-treatment

Study Arms (2)

Raising Our Spirits Together Intervention

EXPERIMENTAL

Behavioral: Raising Our Spirits Together

Enhanced Control Condition

OTHER

Other: Enhanced Control Condition

Interventions

Raising Our Spirits Together 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.

Raising Our Spirits Together Intervention

Enhanced Control Condition 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.

Enhanced Control Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Trinity Lutheran Church

Hillsdale, Michigan, 49242, United States

Location

Jonesville First Presbyterian Church

Jonesville, Michigan, 49250, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Addie Weaver
• Organization: University of Michigan School of Social Work

weaverad@umich.edu

734-615-2122

Study Officials

• Addie Weaver, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 6, 2020
• Study Start: September 20, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: May 22, 2026
• Results First Posted: February 4, 2025

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)