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A Systems-Level Intervention for Rural Adults With Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04502186
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : November 27, 2020
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Addie Weaver, University of Michigan

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 20, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

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.

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.

Primary Outcome Measures :
  1. Change in self-report measure of depressive symptoms [ Time Frame: 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must live in Hillsdale County, Michigan for at least one year
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04502186

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Contact: Addie Weaver, PhD 7346152122

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United States, Michigan
Trinity Lutheran Church Recruiting
Hillsdale, Michigan, United States, 49242
Contact: Jessica Hahn         
Jonesville First Presbyterian Church Recruiting
Jonesville, Michigan, United States, 49250
Contact: Lynne McQuown         
Sponsors and Collaborators
University of Michigan
National Institute of Mental Health (NIMH)
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Principal Investigator: Addie Weaver, PhD University of Michigan
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Responsible Party: Addie Weaver, Assistant Professor, University of Michigan Identifier: NCT04502186    
Other Study ID Numbers: HUM00176192
K01MH110605 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be made available through NIMH Data Archive (NDAR) after the end of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Behavioral Symptoms