Depressive SymptomsNCT05451589
A Trial of a Positive Psychology Intervention for Older Adults (RESET)
A study testing RESET in people with Depressive Symptoms and Anxiety, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Depressive Symptoms, Anxiety, Chronic Pain
- What is being tested?
- RESET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2023to 28 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Physical and Psychosocial Functioning in Older Adults: A Community Health Worker-Led Intervention
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
- Being tested
- RESET, Wellness Check Control
- Medical subject headings
- Depression, Anxiety Disorders, Chronic Pain, Fatigue, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESETBehavioural
Also called Re-Engaging in Self-care, Enjoying Today
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 ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| RESET intervention | Experimental | Participants will engage in a 7-week positive psychology and self-management group telephone-based program. Receives: Behavioral: RESET |
| Wellness check control | Active comparator | Participants will receive educational information and an individual wellness check phone call from a Community Health Worker to screen for unmet social needs. Receives: Behavioral: Wellness Check Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PROMIS-29 Mental (Psychosocial) Summary Score
Brief Description: The PROMIS-29 Mental (Psychosocial) Summary Score is a weighted composite of distress (depression and anxiety), pain (intensity and interference), social participation, fatigue, and sleep. Weights are provided in Hays et al (2018), "PROMIS-29 v2.0 profile physical and mental health summary scores", Quality of Life Research, 1885-1891. Scores are standardized on a T-score metric, with a mean of 50 and a standard deviation of 10 in a referent population. A higher score means more of the concept being measured.
Measured: Baseline, 2 months from baseline, and 8 months from baseline
Secondary outcomes (3)
Change in PROMIS-29 Physical Summary Score
The PROMIS-29 Physical Summary Score is a weighted composite of physical functioning (the domain weighted most heavily), pain, and social participation. Weights are provided in Hays et al (2018), "PROMIS-29 v2.0 profile physical and mental health summary scores", Quality of Life Research, 1885-1891. Scores are standardized on a T-score metric, with a mean of 50 and a standard deviation of 10 in a referent population. A higher score means more of the concept being measured.
Measured: Baseline, 2 months from baseline, and 8 months from baseline
Patient Global Impression of Change (Functioning)
How participant thinks their functioning has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.
Measured: 2 months from baseline, and 8 months from baseline
Change in Connor-Davidson Resilience Scale
This scale measures ability to bounce back from stressful times, on a 10-item scale made up of statements indicating use of resilient coping strategies, which respondents rate on a scale from (0) Never True At All to (4) True Nearly All the Time, for a total score range of 0 to 40. A higher score means greater resilience.
Measured: Baseline, 2 months from baseline, and 8 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start14 Jul 2023
- Primary completion28 May 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Detroit Department of Health
- Responsible party
- Principal investigator, Mary Janevic, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451589
- Sponsor's protocol ID
- HUM00209259
- Other IDs
- R01NR020442
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Physical and Psychosocial Functioning in Older Adults: A Community Health Worker-Led Intervention
- ClinicalTrials.gov ID
- NCT05451589
- Acronym / sponsor ID
- HUM00209259
- Conditions
- Depressive Symptoms, Anxiety, Chronic Pain, Fatigue, Loneliness, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Detroit Department of Health
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 11 Jul 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RESET intervention | Experimental | Behavioral: RESETParticipants will engage in a 7-week positive psychology and self-management group telephone-based program. |
| Wellness check control | Active comparator | Behavioral: Wellness Check ControlParticipants will receive educational information and an individual wellness check phone call from a Community Health Worker to screen for unmet social needs. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| RESETAlso: Re-Engaging in Self-care, Enjoying TodayRESET 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. | Behavioural | RESET intervention |
| Wellness Check ControlAfter 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. | Behavioural | Wellness check control |
Primary outcome
Change in PROMIS-29 Mental (Psychosocial) Summary Score
Time frame: Baseline, 2 months from baseline, and 8 months from baseline
Brief Description: The PROMIS-29 Mental (Psychosocial) Summary Score is a weighted composite of distress (depression and anxiety), pain (intensity and interference), social participation, fatigue, and sleep. Weights are provided in Hays et al (2018), "PROMIS-29 v2.0 profile physical and mental health summary scores", Quality of Life Research, 1885-1891. Scores are standardized on a T-score metric, with a mean of 50 and a standard deviation of 10 in a referent population. A higher score means more of the concept being measured.
3 secondary outcomes
Change in PROMIS-29 Physical Summary Score
Time frame: Baseline, 2 months from baseline, and 8 months from baseline
Patient Global Impression of Change (Functioning)
Time frame: 2 months from baseline, and 8 months from baseline
Change in Connor-Davidson Resilience Scale
Time frame: Baseline, 2 months from baseline, and 8 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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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. This study is not recruiting at the moment.
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 RESET in people with Depressive Symptoms and Anxiety, run by University of Michigan 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 4 inclusion and 4 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 19 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 PROMIS-29 Mental (Psychosocial) Summary Score (time frame: Baseline, 2 months from baseline, and 8 months from baseline). 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 19 Aug 2026.