Depressive SymptomsNCT04502186

A Systems-Level Intervention for Rural Adults With Depression

A study testing Raising Our Spirits Together in people with Depressive Symptoms, run by University of Michigan at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Depressive Symptoms
What is being tested?: Raising Our Spirits Together
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 2 sitesUnited States
Study dates: 20 Sep 2020to 31 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Trinity Lutheran Church
Hillsdale, Michigan, 49242
Jonesville First Presbyterian Church
Jonesville, Michigan, 49250

Other trials in United States

About this study

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
Being tested: Raising Our Spirits Together, Enhanced Control Condition
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Raising Our Spirits TogetherBehavioural
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 ConditionOther
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.

Study groups in NCT04502186
Study group	Role	What they receive
Raising Our Spirits Together Intervention	Experimental	Not described Receives: Behavioral: Raising Our Spirits Together
Enhanced Control Condition	Other	Not described Receives: Other: Enhanced Control Condition

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Outcome will be assessed at baseline, immediately post-treatment (up to 8 weeks), and 12-weeks post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 202031 Jul 2023

First posted6 Aug 2020
Study start20 Sep 2020
Primary completion31 Jul 2023
Study completion31 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Depressive SymptomsStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04502186
Sponsor's protocol ID: HUM00176192
Other IDs: K01MH110605
Status last verified: May 2026
First submitted: 3 Aug 2020
Last updated: 22 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD will be made available through NIMH Data Archive (NDAR) after the end of the study.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depressive Symptoms trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Systems-Level Intervention for Rural Adults With Depression
ClinicalTrials.gov ID: NCT04502186
Acronym / sponsor ID: HUM00176192
Conditions: Depressive Symptoms
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 20 Sep 2020 (actual)
Primary completion: 31 Jul 2023 (actual)
Study completion: 31 Jul 2023 (actual)
First posted: 6 Aug 2020 (actual)
Results: Posted 4 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Raising Our Spirits Together Intervention	Experimental	Behavioral: Raising Our Spirits Together
Enhanced Control Condition	Other	Other: Enhanced Control Condition

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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)

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Raising Our Spirits TogetherRaising 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.	Behavioural	Raising Our Spirits Together Intervention
Enhanced Control ConditionThe 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.	Other	Enhanced Control Condition

Primary outcome

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)

Results and safety

Results posted to the registry on 4 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Raising Our Spirits Together Intervention	40	29
Enhanced Control Condition	30	20

Primary outcome: 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. Mean (Standard Deviation). Unit: score on PHQ-9

Measure	Raising Our Spirits Together Intervention n = 40	Enhanced Control Condition n = 30
PHQ-9 Baseline	13.90 (5.49)	13.43 (4.40)
PHQ-9 Post-treatment	7.00 (5.67)	7.57 (4.03)
PHQ-9 Follow-up	7.72 (7.36)	8.10 (5.51)

Adverse events

Time frame: Adverse event data was collected for each participant from the time of enrollment through study completion, which was, on average, 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Raising Our Spirits Together Intervention	0 of 40 (0%)	1 of 40 (2.5%)	0 of 40
Enhanced Control Condition	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD will be made available through NIMH Data Archive (NDAR) after the end of the study.

Related trials for Depressive Symptoms

RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
RecruitingPhase 1
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Vasopressin Deficiency
Recruiting
Psychopharmacotherapy for Depressive Patients
Major Depressive Disorder
RecruitingObservational study
Characterization and Treatment of Adolescent Depression
Depression

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Addie Weaver, PhD principal investigator

University of Michigan

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Raising Our Spirits Together in people with Depressive Symptoms, run by University of Michigan at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04502186.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.