Clinical trial NCT04966910: Stay Connected: Testing an Intervention to Combat Coronavirus-related Social Isolation Among Older Adults
Official title: Stay Connected: Testing an Intervention to Combat COVID-19 Related Social Isolation Among Seattle-area Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Loneliness
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-07-19
Enrollment: 44
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will use the University of Washington's ALACRITY Center's (UWAC) Discover, Design, Build, \& Test (DDBT) method to develop and test an intervention to address the mental health health needs of older adults in senior housing ("clients") who are forced to not only shelter-in-place but cannot have family or other visitors during this time. Older people (those over 60 years in age) are especially vulnerable and are more likely to have severe - even deadly - coronavirus infection than other age groups. These facts led to the need to have older adults socially isolate in order to protect their health; visits with family and friends are limited, and in senior housing (independent, supported and assisted care residences) have limited such visits by family to one person a day. This necessary practice of social distancing, while addressing an important public health crisis, unintentionally creates social isolation and loneliness, another deadly epidemic amongst the older population. Even before COVID-19, social isolation and loneliness was a prominent mental health and social problem in the aged, one that is associated with increases in other chronic conditions, dementia and suicide. Effective interventions for social isolation exist but are difficult to access and may not address all the concerns older adults have about this particular period of social isolation. The purpose of this proposed study is to deploy an adaptation of Behavioral Activation Therapy called Stay Connected to treat depression in older adults. The adaptation will allow activity directors and staff ("clinicians") in these settings and senior centers to deliver the therapeutic elements of the intervention (behavioral activation) in the context of social distancing/shelter-in-place policies. Social workers in these settings will oversee the activity director and staff delivery of the intervention. The investigators are working with a variety of senior housing types (HUD certified and private systems) and senior centers in Skagit county (rural) and King county (urban) in Washington (WA) so that the resulting intervention is not tied to economic levels or access to digital technology.

Detailed description: Clinicians and clients from 6 rural and urban senior communities or senior centers will participate in this study. Senior communities or senior centers will be randomized to receive training and materials in either Stay Connected or a resource guide. The investigators will work with 2 staff from each community or senior center and conduct baseline, 4 week and 9 week assessments with clinicians and 20 clients from each community setting (N=12 clinicians and 120 clients).

Eligibility criteria: Older Adult Participants

Inclusion Criteria:

1. 60 years of age or older
2. Physical and cognitive ability to complete interviews by phone or using video-chat technology (e.g., Zoom)
3. English speaking
4. Resident of participating Seattle-area senior living communities or member of Seattle-area senior centers
5. Ability to provide consent
6. Score of 5 or higher on Patient Health Questionnaire (PHQ-9) or score of 5 or higher on Generalized Anxiety Disorder Scale (GAD-7) or score of 6 or higher on University of California Los Angeles (UCLA) Loneliness Scale
7. No suicidal ideation

Exclusion Criteria:

1. Under the age of 60
2. Inability to physically and/or cognitively consent and/or participate in study procedures via phone, computer, and/or video call
3. Non-English speaking
4. Scores below inclusion cut-offs on PHQ-9, GAD-7, and UCLA Loneliness Scale

Staff Participants Inclusion Criteria

1. English-speaking
2. Staff members in administration, social work, and/or activities department in Seattle area senior living communities or senior centers
3. Physical ability to complete training in intervention and complete questionnaires by phone, computer, or video-chat technology

Exclusion Criteria

1. Non-English speaking
2. Unable to physically or cognitively consent and/or participate in study procedures via phone, computer, and/or video call (e.g., Zoom)

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 4-Week Follow-Up, and 9-Week Follow-Up
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Baseline, 4-Week Follow-Up, and 9-Week Follow-Up
measure: Sheehan Disability Scale (SDS)
timeFrame: Baseline, 4-Week Follow-Up and 9-Week Follow-Up
Secondary outcomes:
measure: University of California Los Angeles (UCLA) Loneliness Scale
timeFrame: Baseline, 4-Week Follow-Up, and 9-Week Follow-Up
measure: Behavioral Activation Scale (BADS)
timeFrame: Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint.
measure: Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation - Short Version
timeFrame: Baseline, 4-Week Follow-Up, and 9-Week Follow-Up
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Baseline and 9 week follow up
measure: Intervention Usability Scale (IUS)
timeFrame: 9 weeks
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Baseline, 9 week follow up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Patricia Arean, PhD
role: PRINCIPAL_INVESTIGATOR
References: