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

NCT04966910 | Completed Results

• 2 other identifiers: STUDY000110515P50MH115837-03
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Loneliness

Outcome Measures

Primary Outcomes (3)

• Patient Health Questionnaire (PHQ-9)

  The PHQ-9 consists of 9 depression items and one disability item. Each item is associated with a 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. Total score ranges from 0 - 27 and higher scores indicate higher levels of depression symptoms.

  Baseline, 4-Week Follow-Up, and 9-Week Follow-Up

• 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. Total score ranges from 0 - 21, with higher scores mean an increased degree of severity of anxiety symptoms.

  Baseline, 4-Week Follow-Up, and 9-Week Follow-Up

• 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. Total score ranges from 0 - 30, with higher scores indicating greater disruptions to their life from mental health symptoms.

  Baseline, 4-Week Follow-Up and 9-Week Follow-Up

Secondary Outcomes (6)

• University of California Los Angeles (UCLA) Loneliness Scale

  Baseline, 4-Week Follow-Up, and 9-Week Follow-Up

• Behavioral Activation Scale (BADS)

  Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint.

• Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation - Short Version

  Baseline, 4-Week Follow-Up, and 9-Week Follow-Up

• Acceptability of Intervention Measure (AIM)

  Baseline and 9 week follow up

• Intervention Usability Scale (IUS)

  9 weeks

Study Arms (2)

Stay Connected

EXPERIMENTAL

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

Behavioral: Stay Connected

Treatment as usual

ACTIVE COMPARATOR

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

Behavioral: Treatment as usual

Interventions

Stay Connected BEHAVIORAL

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

Stay Connected

Treatment as usual BEHAVIORAL

Regular check-ins, resource/referral provision

Treatment as usual

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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
• No suicidal ideation

You may not qualify if:

• 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
• 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
• 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)

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Michael Pullmann
• Organization: University of Washington

pullmann@uw.edu

206-685-0408

Study Officials

• Patricia Arean, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor, Department of Psychiatry And Behavioral Sciences

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 19, 2021
• Study Start: April 9, 2021
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: April 23, 2024
• Results First Posted: December 14, 2023

Record last verified: 2024-04

Locations

US (1)