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

Primary Purpose

Depression, Anxiety, Loneliness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stay Connected
Treatment as usual
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

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

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)

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stay Connected

Treatment as usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Patient Health Questionnaire (PHQ-9)
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.
Change in Generalized Anxiety Disorder (GAD-7)
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.
Change in Sheehan Disability Scale (SDS)
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

UCLA Loneliness Scale
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.
Behavioral Activation Scale (BADS)
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.
PROMIS Social Isolation - Short Version
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.
Acceptability of Intervention Measure (AIM)
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.
Intervention Usability Scale (IUS)
This measures how easy the intervention/system is to use and learn. Used for interventions (e.g., therapeutic modalities).
Intervention Appropriateness Measure (IAM)
This is a four item measure of how suitable an intervention is for the circumstances.

Full Information

First Posted
June 25, 2021
Last Updated
July 19, 2022
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04966910
Brief Title
Stay Connected: Testing an Intervention to Combat COVID-19 Related Social Isolation Among Seattle-area Older Adults
Official Title
Stay Connected: Testing an Intervention to Combat COVID-19 Related Social Isolation Among Seattle-area Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
June 13, 2022 (Actual)
Study Completion Date
June 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)

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
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Loneliness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stay Connected
Arm Type
Experimental
Arm Description
Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals
Intervention Type
Behavioral
Intervention Name(s)
Stay Connected
Intervention Description
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
Intervention Name(s)
Treatment as usual
Intervention Description
Regular check-ins, resource/referral provision
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
Change from Baseline PHQ-9 at 4 Weeks and 9 Weeks
Title
Change in Generalized Anxiety Disorder (GAD-7)
Description
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.
Time Frame
Change from Baseline GAD-7 at 4 Weeks and 9 Weeks
Title
Change in Sheehan Disability Scale (SDS)
Description
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.
Time Frame
Change from Baseline SDS at 4 Weeks and 9 Weeks
Secondary Outcome Measure Information:
Title
UCLA Loneliness Scale
Description
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.
Time Frame
Change from Baseline UCLA Loneliness Scale at 4 weeks and 9 weeks
Title
Behavioral Activation Scale (BADS)
Description
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.
Time Frame
Change from baseline BADS at 4 weeks and 9 weeks
Title
PROMIS Social Isolation - Short Version
Description
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.
Time Frame
Change from Baseline PROMIS Social Isolation at 4 weeks and 9 weeks
Title
Acceptability of Intervention Measure (AIM)
Description
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.
Time Frame
Baseline and at study completion (average of 9 months later)
Title
Intervention Usability Scale (IUS)
Description
This measures how easy the intervention/system is to use and learn. Used for interventions (e.g., therapeutic modalities).
Time Frame
Baseline and at study completion (average of 9 months later)
Title
Intervention Appropriateness Measure (IAM)
Description
This is a four item measure of how suitable an intervention is for the circumstances.
Time Frame
Baseline and at study completion (average of 9 months later)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Older Adult Participants Inclusion Criteria: 60 years of age or older Physical and cognitive ability to complete interviews by phone or using video-chat technology (e.g., Zoom) English speaking Resident of participating Seattle-area senior living communities or member of Seattle-area senior centers Ability to provide consent 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 No suicidal ideation Exclusion Criteria: Under the age of 60 Inability to physically and/or cognitively consent and/or participate in study procedures via phone, computer, and/or video call Non-English speaking Scores below inclusion cut-offs on PHQ-9, GAD-7, and UCLA Loneliness Scale Staff Participants Inclusion Criteria English-speaking Staff members in administration, social work, and/or activities department in Seattle area senior living communities or senior centers Physical ability to complete training in intervention and complete questionnaires by phone, computer, or video-chat technology Exclusion Criteria Non-English speaking Unable to physically or cognitively consent and/or participate in study procedures via phone, computer, and/or video call (e.g., Zoom)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Arean, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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