Community Activity Program for Depression

(ARCH Trial)

Overseen By Brad Appelhans, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Under 18, Not fluent English, Uncontrolled mental illness, Suicidality risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new approach to health outreach can improve depression, weight management, and physical activity more effectively than traditional methods. It emphasizes engaging people in enjoyable and rewarding community activities. Those who may benefit include individuals feeling down, not very active, or carrying extra weight, particularly if they receive care from certain health centers or live in underresourced areas. Participants will join one of two groups: one receiving the new community-focused approach (ARCH) and the other following traditional health outreach methods.

As an unphased trial, this study provides a unique opportunity to explore innovative health strategies that could enhance well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this health outreach intervention is safe?

Research has shown that both treatments in this trial have yielded positive results in past studies, so their safety merits discussion.

For the ARCH program, studies indicate it significantly reduces depression symptoms. Participants in these studies reported long-term improvement. While the studies focus on effectiveness, they do not mention major safety issues, suggesting general safety.

Similarly, Traditional Health Outreach treatments have been studied for their effects on mental health. Research shows they effectively reduce anxiety and depression symptoms. Although specific safety details are not highlighted, the absence of negative reports suggests these treatments are also safe.

In summary, based on past research, both treatments appear safe, with no major side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for depression because they offer a fresh approach beyond traditional medication and therapy. ARCH, the experimental treatment, emphasizes improving depressive symptoms through enhanced physical activity and weight management, which is not the primary focus of existing options like antidepressants and cognitive-behavioral therapy. Meanwhile, the Traditional Health Outreach aims to connect individuals with healthcare resources and support, providing a community-based intervention that supplements personal health management. Both treatments aim to empower individuals by integrating lifestyle changes and community support, potentially offering more holistic benefits than current standards.

What evidence suggests that this trial's treatments could be effective for depression?

Research has shown that community activities can help reduce anxiety and depression. One study found that participating in an activity program improved mood and quality of life for people with depression, similar to the benefits of social visits. Another study showed that exercise can ease depression and enhance thinking skills. This trial will compare two community activity programs: the ARCH program, which focuses on improving depressive symptoms, physical activity, and weight management, and the Traditional Health Outreach program, which emphasizes screening, referral to healthcare resources, and support. These findings suggest that joining community activities and exercising, as in the ARCH program, may help people with depression. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for people who have used a health center in the past 2 years, live in deprived neighborhoods, feel persistently sad or depressed (with a specific test score showing depression), are overweight, and don't get much exercise. It's not for everyone; there are some rules about who can join.

Inclusion Criteria

My BMI is 28 or higher.

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

Elevated depressive symptoms (10-item CES-D score≥10)94,95

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ARCH intervention or traditional health outreach for 4 months to improve depressive symptoms, physical activity, and weight management

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ARCH
• Traditional Health Outreach

Trial Overview The study compares two ways to help people with depression from areas without many resources: ARCH promotes fun activities and socializing, while Traditional Health Outreach gives standard health advice. The goal is to see which one better reduces sadness, weight issues, and gets people moving more.

How Is the Trial Designed?

Group I: ARCH Experimental Treatment 1 Intervention

4-month health outreach intervention to improve depressive symptoms, physical activity, and weight management

Group II: Traditional Health Outreach Active Control 1 Intervention

4-month health outreach intervention focused on screening, referral to healthcare resources, and support

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

Community rehabilitation skill training for depression significantly reduced depressive symptoms and improved social functioning in patients, as evidenced by lower scores on the Hamilton Depression Scale and Social Disability Screening Schedule after 8 weeks of intervention.

The study involved 74 patients with depression, and the results suggest that such rehabilitation programs are effective and suitable for broader implementation in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of community rehabilitation skill on patients with depression]. Zu, S., Lin, X., Guo, Z.[2021]

Cognitive behavior therapy (CBT) significantly reduced depressive symptoms and increased perceived social support among elderly participants immediately after a 12-week intervention, compared to a control group.

The physical fitness exercise program also effectively decreased depressive symptoms over time and improved physical health outcomes, such as increased walking distance and better quality of life, suggesting it may be a more beneficial long-term intervention for elderly adults with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical fitness exercise versus cognitive behavior therapy on reducing the depressive symptoms among community-dwelling elderly adults: A randomized controlled trial. Huang, TT., Liu, CB., Tsai, YH., et al.[2018]

An 18-month community partnership in south Los Angeles successfully developed action plans to improve depression recognition and referral among social service caseworkers, including a website and a toolkit.

The process enhanced community awareness of depression and fostered collaboration between community members and academic partners, leading to better adaptation of programs for local service providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Building Wellness project: a case history of partnership, power sharing, and compromise. Jones, D., Franklin, C., Butler, BT., et al.[2021]

A review of 27 community-based intervention studies showed that while 88% reported participation rates among the target audience, only 11% reported participation rates among community organizations, highlighting a gap in understanding how well interventions are adopted in real-world settings.

Only 30% of studies assessed whether individuals maintained behavior changes over time, and none reported on the long-term institutionalization of interventions, indicating a need for better reporting on external validity to enhance the generalizability of findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior change intervention research in community settings: how generalizable are the results? Dzewaltowski, DA., Estabrooks, PA., Klesges, LM., et al.[2019]

The eB4CAST framework is a systematic tool designed to enhance the usability and sustainability of community-based programs by effectively capturing and transforming research findings into actionable dissemination reports.

By utilizing both direct and indirect data collection methods, eB4CAST forecasts program needs and highlights impacts, making it adaptable for various public health interventions and ensuring ongoing evaluation and responsiveness to community needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

eB4CAST: An Evidence-Based Tool to Promote Dissemination and Implementation in Community-Based, Public Health Research. Olfert, MD., Hagedorn, RL., Barr, ML., et al.[2023]

Community Engagement and Planning (CEP) significantly improved mental health outcomes for clients with multiple chronic medical conditions (MCC) compared to Resources for Services (RS), including reduced depression rates and improved mental wellness at 6 months.

CEP also led to decreased work-loss days and lower risks of behavioral health hospitalizations and chronic homelessness among MCC clients, highlighting its effectiveness in enhancing quality of life for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Coalitions Versus Technical Assistance for Depression Quality Improvement in Persons with Multiple Chronic Conditions. Springgate, B., Tang, L., Ong, M., et al.[2019]

Community-based interventions can effectively improve heart health knowledge and reduce risk factors, as demonstrated by the Stanford Five City Project, which showed a 12% increase in knowledge and significant declines in smoking prevalence and blood pressure.

Despite early successes, later studies have struggled to replicate these results, suggesting that while community-based approaches are valuable, they may require more resources and commitment than targeted interventions for high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public health impact of community-based nutrition and lifestyle interventions. Verheijden, MW., Kok, FJ.[2019]

Community-based organizations (CBOs) are crucial for delivering evidence-based programs like PEARLS to underserved older adults, especially during the COVID-19 pandemic when isolation and depression increased.

CBOs expressed a need for culturally flexible programs, stable funding, and accessible training to effectively adopt PEARLS, highlighting the importance of aligning program components with the specific needs of the communities they serve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partnering with community-based organizations to improve equitable access to depression care for underserved older adults in the U.S.: Qualitative formative research. Steinman, LE., Parrish, AT., Kohn, MJ., et al.[2023]

The Supporting Wellness working group successfully established a collaborative project in Los Angeles that focuses on mental health advocacy, including securing a position on a countywide committee to influence mental health policy and funding.

The project highlights the importance of community perspectives in developing effective mental health interventions, emphasizing that significant time and effort are needed to build the necessary infrastructure for successful community-academic partnerships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting wellness through policy and advocacy: a case history of a working group in a community partnership initiative to address depression. Stockdale, S., Patel, K., Gray, R., et al.[2016]

This scoping review analyzed 44 articles on community-based health promotion interventions, primarily focusing on obesity prevention and healthy nutrition for children and adolescents, with most studies conducted in the USA.

The review found a variety of evaluation designs used, including randomized controlled trials and quasi-experimental designs, but noted a lack of comprehensive evaluation frameworks, making it challenging to derive holistic evaluation approaches from existing literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of community-based health promotion interventions in children and adolescents in high-income countries: a scoping review on strategies and methods used. Bader, B., Coenen, M., Hummel, J., et al.[2023]

The Community Education Monitoring System (CEMS) effectively tracks various aspects of behavior change interventions, such as the number and type of activities, target audiences, and funding sources, using data from established health programs like the Stanford Five-City Project.

CEMS enhances program evaluation by providing a structured way to measure program reach and effectiveness, allowing for better comparisons across different health promotion initiatives and ensuring that theoretical frameworks are applied in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community education monitoring system: methods from the Stanford Five-City Project, the Minnesota Heart Health Program and the Pawtucket Heart Health Program. Flora, JA., Lefebvre, RC., Murray, DM., et al.[2019]

The Community based Depression Intervention Programme (ComDIP) significantly reduced depression severity in women, with a mean Hamilton Depression Rating scale score dropping from 29.2 to 12.2 after 8 weeks, compared to a smaller reduction in the treatment as usual group.

ComDIP, which combines psycho-social interventions and drug treatment, was shown to be effective in a randomized controlled trial involving 60 women, demonstrating its potential as a viable mental health solution in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of community-based depression intervention programme (ComDIP) to manage women with depression in primary care- randomised control trial. Indu, PS., Anilkumar, TV., Vijayakumar, K., et al.[2019]

The expert panel recommended home or primary care clinic-based depression care management interventions and individual cognitive behavioral therapy as effective treatments for late-life depression, based on a systematic review of evidence.

Interventions such as education, skills training, and physical rehabilitation were not recommended as primary treatments for late-life depression, highlighting the need for targeted approaches that specifically address depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for treating depression in community-based older adults. Steinman, LE., Frederick, JT., Prohaska, T., et al.[2018]

In a study involving 1018 adults with depressive symptoms, the community engagement and planning (CEP) approach showed initial benefits in improving mental health-related quality of life (MHRQL) at 6 months, but these benefits were not consistently observed at 12 months, indicating a need for further evaluation of long-term efficacy.

While CEP reduced behavioral health hospitalizations at 6 months, this effect diminished by 12 months, suggesting that while CEP may be beneficial in the short term, its long-term impact on service use and mental health outcomes requires more investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

12-month outcomes of community engagement versus technical assistance to implement depression collaborative care: a partnered, cluster, randomized, comparative effectiveness trial. Chung, B., Ong, M., Ettner, SL., et al.[2023]

In a study involving 1,004 participants with depression, a community coalition approach (Community Engagement and Planning, CEP) showed initial benefits over individual program assistance (Resources for Services, RS) in improving mental health-related quality of life and reducing hospitalizations at six months.

After three years, while there were no significant differences in primary mental health outcomes between CEP and RS, CEP participants experienced modest improvements in physical health-related quality of life and fewer behavioral health hospital nights, indicating potential long-term benefits of community engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Community-Partnered, Participatory, Cluster-Randomized Study of Depression Care Quality Improvement: Three-Year Outcomes. Ong, MK., Jones, L., Aoki, W., et al.[2022]

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