DepressionARCHNCT06093282
Activity and Recreation in Communities for Health
A study testing ARCH and Traditional Health Outreach in people with Depression, run by Rush University Medical Center at 1 site in United States.
Trial summary
This project tests whether a health outreach intervention that promotes engagement in rewarding, community-based recreational and social activities can produce greater improvements in depressive symptoms, adiposity, and physical activity among people from underresourced communities than traditional health outreach… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- ARCH and Traditional Health Outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Member of an underserved population defined by either of the following:
- Received health care at a federally qualified health center within the past 2 years
- Living in a neighborhood with an Area Deprivation Index ≤ 20th percentile
- Elevated depressive symptoms (10-item CES-D score≥10)94,95
- One or both of the following modifiable cardiometabolic risk factors:
- Excess adiposity (body mass index ≥ 28.0 kg/m2)
- Physically inactive according to the 2018 U.S. Physical Activity Guidelines:96 less than 150 minutes of moderate intensity, 75 minutes of vigorous intensity, or an equivalent combination of moderate and vigorous intensity activity, per week based on a 7-day accelerometry protocol
Who cannot join
- Under 18 years of age
- Not fluent in English
- Uncontrolled serious mental illness
- High risk for suicidality on the Columbia Suicide Severity Scale
- Conditions jeopardizing staff safety at home data visits
- Individual is dependent on a caretaker for activities of daily living
- Currently lives or plans to move outside Cook and Lake Counties
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Activity and Recreation in Communities for Health (ARCH) - Pilot Study
This project tests whether a health outreach intervention that promotes engagement in rewarding, community-based recreational and social activities can produce greater improvements in depressive symptoms, adiposity, and physical activity among people from underresourced communities than traditional health outreach approaches.
Read the detailed description
Underresourced communities are affected by structural barriers and detrimental conditions that contribute to disparities in mental and physical health. People living in these communities may also face financial and logistical barriers to engaging in meaningful and rewarding activities in their community, which is linked to risk for depression and cardiometabolic disease in emerging health behavior models. There is also evidence that depression, physical inactivity, and reward-driven overeating exhibit reciprocal causal relationships that promote cardiometabolic disease through multiple pathways, which supports the value of intervening on these co-occurring risk factors simultaneously. Structured interventions that increase engagement in rewarding activities are effective for treating depression, but this approach has not been adapted for broad dissemination in underresourced populations that face challenges accessing the health care system, and have a high burden of cardiometabolic risk factors.
This project will refine and test a novel approach for reducing the burden of depression and cardiometabolic disease in underresourced communities. The Activity and Recreation in Communities for Health (ARCH) intervention is designed to promote engagement in rewarding activities through an adaptation of Behavioral Activation Treatment for Depression, and direct provision of resources to engage in rewarding recreational and social activities both independently and through our partnering community-based organizations. ARCH is designed to be delivered in participants' homes and community venues by a health outreach workforce, which addresses barriers to accessing treatment. Aim 1 is to engage community stakeholders in the process of co-designing ARCH to maximize feasibility, acceptability, and uptake. Aim 2 is to conduct an initial evaluation of the refined ARCH intervention among adults from underresourced communities with depression. Changes in depressive symptoms, adiposity, and physical activity over four months will be compared between those randomly assigned to ARCH versus a traditional health outreach comparator. In addition to clinical outcomes, key metrics of program uptake, cost, and feasibility will be quantified, and hypothesized mechanisms underlying treatment effects will be explored (Aim 3). Findings will inform the design of a definitive implementation trial, and determine the potential value of incorporating behavioral activation in other outreach interventions for underserved populations
- Conditions
- Depression
- Being tested
- ARCH, Traditional Health Outreach
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARCHBehavioural
ARCH is a 4-month health outreach intervention that includes the following components:
- Screening and referral to address social determinants of health
- A 12-session adaptation of Behavioral Activation Treatment for Depression
- Weekly contacts from an outreach worker
- Optional resources aimed at promoting physical activity and weight management
Traditional Health OutreachBehavioural
The Traditional Health Outreach comparator is a 4-month health outreach intervention that includes the following components:
- Screening and referral to address social determinants of health
- Support calls from an outreach worker at least once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| ARCH | Experimental | 4-month health outreach intervention to improve depressive symptoms, physical activity, and weight management Receives: Behavioral: ARCH |
| Traditional Health Outreach | Active comparator | 4-month health outreach intervention focused on screening, referral to healthcare resources, and support Receives: Behavioral: Traditional Health Outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Change in depressive symptoms on the 10-item version of the Centers for Epidemiological Studies - Depression Scale (CES-D-10)
Measured: 4 months
Secondary outcomes (2)
Physical activity
Change in daily minutes of moderate-vigorous physical activity measured by accelerometer
Measured: 4 months
Weight loss
Weight change will be calculated as a percentage of baseline weight
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Sep 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Model description
- Two-arm, parallel group design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093282
- Sponsor's protocol ID
- 23080302
- Acronym
- ARCH
- Status last verified
- Mar 2026
- First submitted
- 16 Oct 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared in accordance with the study's NIH Data Management and Sharing Plan.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity and Recreation in Communities for Health (ARCH) - Pilot Study
- ClinicalTrials.gov ID
- NCT06093282
- Acronym / sponsor ID
- ARCH / 23080302
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- University of Chicago
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project tests whether a health outreach intervention that promotes engagement in rewarding, community-based recreational and social activities can produce greater improvements in depressive symptoms, adiposity, and physical activity among people from underresourced communities than traditional health outreach approaches.
Detailed description
Underresourced communities are affected by structural barriers and detrimental conditions that contribute to disparities in mental and physical health. People living in these communities may also face financial and logistical barriers to engaging in meaningful and rewarding activities in their community, which is linked to risk for depression and cardiometabolic disease in emerging health behavior models. There is also evidence that depression, physical inactivity, and reward-driven overeating exhibit reciprocal causal relationships that promote cardiometabolic disease through multiple pathways, which supports the value of intervening on these co-occurring risk factors simultaneously. Structured interventions that increase engagement in rewarding activities are effective for treating depression, but this approach has not been adapted for broad dissemination in underresourced populations that face challenges accessing the health care system, and have a high burden of cardiometabolic risk factors.
This project will refine and test a novel approach for reducing the burden of depression and cardiometabolic disease in underresourced communities. The Activity and Recreation in Communities for Health (ARCH) intervention is designed to promote engagement in rewarding activities through an adaptation of Behavioral Activation Treatment for Depression, and direct provision of resources to engage in rewarding recreational and social activities both independently and through our partnering community-based organizations. ARCH is designed to be delivered in participants' homes and community venues by a health outreach workforce, which addresses barriers to accessing treatment. Aim 1 is to engage community stakeholders in the process of co-designing ARCH to maximize feasibility, acceptability, and uptake. Aim 2 is to conduct an initial evaluation of the refined ARCH intervention among adults from underresourced communities with depression. Changes in depressive symptoms, adiposity, and physical activity over four months will be compared between those randomly assigned to ARCH versus a traditional health outreach comparator. In addition to clinical outcomes, key metrics of program uptake, cost, and feasibility will be quantified, and hypothesized mechanisms underlying treatment effects will be explored (Aim 3). Findings will inform the design of a definitive implementation trial, and determine the potential value of incorporating behavioral activation in other outreach interventions for underserved populations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel group design
| Arm | Type | Receives |
|---|---|---|
| ARCH | Experimental | Behavioral: ARCH4-month health outreach intervention to improve depressive symptoms, physical activity, and weight management |
| Traditional Health Outreach | Active comparator | Behavioral: Traditional Health Outreach4-month health outreach intervention focused on screening, referral to healthcare resources, and support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Member of an underserved population defined by either of the following:
- Elevated depressive symptoms (10-item CES-D score≥10)94,95
- One or both of the following modifiable cardiometabolic risk factors:
Key exclusion criteria (7 listed)
- Under 18 years of age
- Not fluent in English
- Uncontrolled serious mental illness
- High risk for suicidality on the Columbia Suicide Severity Scale
- Conditions jeopardizing staff safety at home data visits
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 |
|---|---|---|
| ARCHARCH is a 4-month health outreach intervention that includes the following components: * Screening and referral to address social determinants of health * A 12-session adaptation of Behavioral Activation Treatment for Depression * Weekly contacts from an outreach worker * Optional resources aimed at promoting physical activity and weight management | Behavioural | ARCH |
| Traditional Health OutreachThe Traditional Health Outreach comparator is a 4-month health outreach intervention that includes the following components: * Screening and referral to address social determinants of health * Support calls from an outreach worker at least once every 3 weeks | Behavioural | Traditional Health Outreach |
Primary outcome
Depressive symptoms
Time frame: 4 months
Change in depressive symptoms on the 10-item version of the Centers for Epidemiological Studies - Depression Scale (CES-D-10)
2 secondary outcomes
Physical activity
Time frame: 4 months
Weight loss
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: Yes. Data will be shared in accordance with the study's NIH Data Management and Sharing Plan.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARCH and Traditional Health Outreach in people with Depression, run by Rush University Medical Center at 1 site 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 7 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Depressive symptoms (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2026.