A Systems-Level Intervention for Rural Adults With Depression

Depressive Symptoms Clinical Trial

Official title:

A Systems-Level Intervention for Rural Adults With Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04502186
• Other study ID #: HUM00176192
• Secondary ID: K01MH110605
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

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