A Trial of a Positive Psychology Intervention for Older Adults (RESET)

NCT ID: NCT05451589

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2026-06-30

Brief Summary

The heightened vulnerability to COVID-19 of African American older adults in Detroit, Michigan and other marginalized communities is linked to systemic racism experienced over the life course. Structural inequities also magnify the pandemic's impact on older adults' physical and psychosocial functioning. Many older adults in Detroit, burdened by poor health even before the pandemic, face a downward spiral of increased distress, reduced physical and social activity, and physical deconditioning. RESET (Re-Engaging in Self-care, Enjoying Today) is a self-management and resilience-building intervention led by community health workers (CHWs) at the Detroit Health Department (DHD). The central hypothesis of this study is that RESET, with components that include group telephone calls, a podcast series, and activity trackers, will improve psychosocial and physical functioning at 2 and 8 months. Specific aims are: 1) With input from a Community Advisory Board, modify RESET for group delivery and refine content after testing in a mini-pilot (n=10). 2) Conduct a randomized, controlled trial to assess the impact of RESET (compared to a one-time /telephone wellness check) on PROMIS-29 Psychosocial Score (a weighted combination of distress, fatigue, pain, social participation and sleep) among 456 primarily African American older adults age 50 and over who are at elevated risk of poor functioning. 3) Collect qualitative (interview) data from participants and other stakeholders, and use this data to better understand trial results, as well as to assess community impact and inform a dissemination toolkit.

Conditions

Depressive Symptoms; Anxiety; Chronic Pain; Fatigue; Loneliness; Stress, Psychological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RESET intervention

Participants will engage in a 7-week positive psychology and self-management group telephone-based program.

Group Type: EXPERIMENTAL

RESET

Intervention Type: BEHAVIORAL

RESET consists of 7 weekly group phone sessions led by Community Health Workers, along with an accompanying podcast series.Topics will include positive psychology, physical activity, social connection, eating well, relaxation, and more. There will be one individual session with the Community Health Worker to screen for unmet social needs and to offer connections to resources as needed. In the group sessions, participants will set goals incorporating positive activities and strategies to improve daily functioning. Up-to-date information related to COVID-19 prevention and treatment will be provided.

Wellness check control

Participants will receive educational information and an individual wellness check phone call from a Community Health Worker to screen for unmet social needs.

Group Type: ACTIVE_COMPARATOR

Wellness Check Control

Intervention Type: BEHAVIORAL

After completing the baseline survey, control group participants will be mailed an educational packet consisting of information about COVID-19 prevention and treatment, as well as essential community resources. Control group participants will also be invited to take part in a "wellness check" telephone session with a Community Health Worker, about a half-hour long, at which a social needs screener will be administered, and any needed referrals will be made. After completing the 8-month follow up, they will have the opportunity to participate in the full intervention.

Interventions

RESET

RESET consists of 7 weekly group phone sessions led by Community Health Workers, along with an accompanying podcast series.Topics will include positive psychology, physical activity, social connection, eating well, relaxation, and more. There will be one individual session with the Community Health Worker to screen for unmet social needs and to offer connections to resources as needed. In the group sessions, participants will set goals incorporating positive activities and strategies to improve daily functioning. Up-to-date information related to COVID-19 prevention and treatment will be provided.

Intervention Type: BEHAVIORAL

Wellness Check Control

After completing the baseline survey, control group participants will be mailed an educational packet consisting of information about COVID-19 prevention and treatment, as well as essential community resources. Control group participants will also be invited to take part in a "wellness check" telephone session with a Community Health Worker, about a half-hour long, at which a social needs screener will be administered, and any needed referrals will be made. After completing the 8-month follow up, they will have the opportunity to participate in the full intervention.

Intervention Type: BEHAVIORAL

Other Intervention Names

Re-Engaging in Self-care, Enjoying Today

Eligibility Criteria

Inclusion Criteria

• Any elevated physical or psychosocial symptoms as follows:

Depression: Score ≥3 on the Patient Health Questionnaire-2 (PHQ-2); Anxiety: Score >= 3 on the GAD-2 anxiety screening scale; Fatigue: Rating >=4 on a 0 to 10 scale (0 = fatigued at all and 10 = extremely fatigued); Loneliness, as indicated by a score >=6 on 3-item UCLA Loneliness Scale; Perceived stress, as indicated by a mean score >3 on the Perceived Stress Scale-4; Chronic pain: Self-reported pain in muscles or joints for >3 months, >4 (0-10 scale) mean pain intensity over last month, and >=1 day in past month when pain made it difficult to do usual activities.

• Have a cell or landline phone.
• Able to converse comfortably in English.

Exclusion Criteria

• Serious acute illness or hospitalization in last month.
• Planned major surgery in next three months that would interfere with program participation (e.g., knee or hip replacement).
• Severe cognitive impairment or dementia.
• Any other diseases or conditions that would impair cooperation with the study team or ability to complete study procedures, as determined by the clinicians on the investigative team. This would include but not be limited to severe psychiatric disorders, active suicidal ideations or history of suicide attempts, and an uncontrolled drug and/or alcohol addiction).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Detroit Department of Health

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Mary Janevic

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

HUM00209259

Identifier Type: -

Identifier Source: org_study_id

R01NR020442

Identifier Type: NIH

Identifier Source: secondary_id

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