Stay Connected: Testing an Intervention to Combat COVID-19 Related Social Isolation Among Seattle-area Older Adults

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT04966910
Collaborator
National Institute of Mental Health (NIMH) (NIH)
39
1
2
14.2
2.7

Study Details

Study Description

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 MH health needs of older adults in senior housing 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 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 (rural) and King (urban) counties of WA so that the resulting intervention is not tied to economic levels or access to digital technology.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Stay Connected
  • Behavioral: Treatment as usual
N/A

Detailed Description

Staff and residents 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 staff and 20 residents from each community setting (N=12 staff and 120 residents).

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Stay Connected: Testing an Intervention to Combat COVID-19 Related Social Isolation Among Seattle-area Older Adults
Actual Study Start Date :
Apr 6, 2021
Actual Primary Completion Date :
Jun 13, 2022
Actual Study Completion Date :
Jun 13, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stay Connected

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

Behavioral: 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.

Active Comparator: Treatment as usual

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

Behavioral: Treatment as usual
Regular check-ins, resource/referral provision

Outcome Measures

Primary Outcome Measures

  1. Change in Patient Health Questionnaire (PHQ-9) [Change from Baseline PHQ-9 at 4 Weeks and 9 Weeks]

    The PHQ-9 consists of 9 depression items and one disability item. Each time is associated with a DMS symptom of depression, which the participant rates whether or not they have experienced the symptom over the last two weeks, with severity rating of 0-3. It is one of the few measures that is brief (it takes less than one minute to give) and has been found to have excellent sensitivity to change over time. Older adult participants will complete this measure.

  2. Change in Generalized Anxiety Disorder (GAD-7) [Change from Baseline GAD-7 at 4 Weeks and 9 Weeks]

    To assess for co-occurring anxiety, we will use the GAD-7, a 7- item screener for generalized anxiety. It consists of items related to GAD. Participants rate on a scale of 0-3 how much they have experienced in the last two weeks. The scale is a valid screener for GAD. Older adult participants will complete this measure.

  3. Change in Sheehan Disability Scale (SDS) [Change from Baseline SDS at 4 Weeks and 9 Weeks]

    The SDS will be used as measure of disability/functional status. This is a brief analog disability scale, which uses visual-spatial, numeric and verbal anchors. The scale has been validated in medical and psychiatric populations with a variety of psychiatric diagnoses. Older adult participants will complete this measure.

Secondary Outcome Measures

  1. UCLA Loneliness Scale [Change from Baseline UCLA Loneliness Scale at 4 weeks and 9 weeks]

    A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way"). Older adult participants will complete this measure.

  2. Behavioral Activation Scale (BADS) [Change from baseline BADS at 4 weeks and 9 weeks]

    The Behavioral Activation for Depression Scale (BADS) can be used to track changes weekly in the behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. It examines changes in the following areas: activation, avoidance/rumination, work/school impairment, and social impairment. The BADS consists of 25 questions, each rated on a seven point scale ranging from 0 (not at all) to 6 (completely). Older adult participants will complete this measure.

  3. PROMIS Social Isolation - Short Version [Change from Baseline PROMIS Social Isolation at 4 weeks and 9 weeks]

    The PROMIS Social Isolation item bank assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. Older adult participants will complete this measure.

  4. Acceptability of Intervention Measure (AIM) [Baseline and at study completion (average of 9 months later)]

    This is a four item measure of intervention acceptability, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. Staff participants will complete this measure.

  5. Intervention Usability Scale (IUS) [Baseline and at study completion (average of 9 months later)]

    This measures how easy the intervention/system is to use and learn. Used for interventions (e.g., therapeutic modalities).

  6. Intervention Appropriateness Measure (IAM) [Baseline and at study completion (average of 9 months later)]

    This is a four item measure of how suitable an intervention is for the circumstances.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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 PHQ-9 OR score of 5 or higher on GAD-7 OR score of 6 or higher on 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Washington Seattle Washington United States 98195

Sponsors and Collaborators

  • University of Washington
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Patricia Arean, PhD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pat Arean, Professor, School of Medicine: Psychiatry And Behavioral Sciences, University of Washington
ClinicalTrials.gov Identifier:
NCT04966910
Other Study ID Numbers:
  • STUDY00011051
  • 5P50MH115837-03
First Posted:
Jul 19, 2021
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2022