Stay Connected: Testing an Intervention to Combat Coronavirus-related Social Isolation Among Older Adults

NCT ID: NCT04966910

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-09
• Study Completion Date: 2022-06-13

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).

Conditions

Depression; Anxiety; Loneliness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stay Connected

Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults

Group Type: EXPERIMENTAL

Stay Connected

Intervention Type: BEHAVIORAL

Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles.

Treatment as usual

Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

Regular check-ins, resource/referral provision

Interventions

Stay Connected

Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles.

Intervention Type: BEHAVIORAL

Treatment as usual

Regular check-ins, resource/referral provision

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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. 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

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Michael Pullmann

Research Associate Professor, Department of Psychiatry And Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Arean, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5P50MH115837-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00011051

Identifier Type: -

Identifier Source: org_study_id