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Completed

NCT Number: NCT04502186

A Systems-Level Intervention for Rural Adults With Depression

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trinity Lutheran Church, Hillsdale, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Self-report Measure of Depressive Symptoms

    Time frame: Outcome will be assessed at baseline, immediately post-treatment (up to 8 weeks), 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)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 6, 2020
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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