A Systems-Level Intervention for Rural Adults With Depression

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04502186

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Locations

Arms

24.3

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Depressive Symptoms	Behavioral: Raising Our Spirits Together Other: Enhanced Control Condition	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Systems-Level Intervention for Rural Adults With Depression

Actual Study Start Date :

Sep 20, 2020

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Raising Our Spirits Together 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	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.

Arm

Intervention/Treatment

Experimental: Raising Our Spirits Together 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

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Trinity Lutheran Church	Hillsdale	Michigan	United States	49242
2	Jonesville First Presbyterian Church	Jonesville	Michigan	United States	49250

Sponsors and Collaborators

University of Michigan
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: Addie Weaver, PhD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Addie Weaver, Assistant Professor, University of Michigan

ClinicalTrials.gov Identifier:

NCT04502186

Other Study ID Numbers:

HUM00176192
K01MH110605

First Posted:

Aug 6, 2020

Last Update Posted:

Dec 6, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of Dec 6, 2021