search
Back to results

A Trial of a Positive Psychology Intervention for Older Adults (RESET) During the COVID-19 Pandemic

Primary Purpose

Depressive Symptoms, Anxiety, Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RESET
Wellness Check Control
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of MichiganRecruiting
  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RESET intervention

Wellness check control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
July 7, 2022
Last Updated
May 30, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Nursing Research (NINR), Detroit Department of Health
search

1. Study Identification

Unique Protocol Identification Number
NCT05451589
Brief Title
A Trial of a Positive Psychology Intervention for Older Adults (RESET) During the COVID-19 Pandemic
Official Title
Improving Physical and Psychosocial Functioning in Underserved Older Adults During the COVID-19 Pandemic: A Community Health Worker-Led Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Nursing Research (NINR), Detroit Department of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Anxiety, Chronic Pain, Fatigue, Loneliness, Stress, Psychological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
456 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RESET intervention
Arm Type
Experimental
Arm Description
Participants will engage in a 7-week positive psychology and self-management group telephone-based program.
Arm Title
Wellness check control
Arm Type
Active Comparator
Arm Description
Participants will receive educational information and an individual wellness check phone call from a Community Health Worker to screen for unmet social needs.
Intervention Type
Behavioral
Intervention Name(s)
RESET
Other Intervention Name(s)
Re-Engaging in Self-care, Enjoying Today
Intervention Description
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
Intervention Name(s)
Wellness Check Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in PROMIS-29 Mental (Psychosocial) Summary Score
Description
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.
Time Frame
Baseline, 2 months from baseline, and 8 months from baseline
Secondary Outcome Measure Information:
Title
Change in PROMIS-29 Physical Summary Score
Description
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.
Time Frame
Baseline, 2 months from baseline, and 8 months from baseline
Title
Patient Global Impression of Change (Functioning)
Description
How participant thinks their functioning has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.
Time Frame
2 months from baseline, and 8 months from baseline
Title
Change in Connor-Davidson Resilience Scale
Description
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.
Time Frame
Baseline, 2 months from baseline, and 8 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Janevic
Phone
7346473194
Email
mjanevic@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Lindsay
Email
reblin@umich.edu
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Lindsay

12. IPD Sharing Statement

Learn more about this trial

A Trial of a Positive Psychology Intervention for Older Adults (RESET) During the COVID-19 Pandemic

We'll reach out to this number within 24 hrs