跳至主要内容
临床试验/NCT04966910
NCT04966910已完成不适用

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

University of Washington2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年4月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Patient Health Questionnaire (PHQ-9)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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 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

排除标准

  • 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)

结局指标

主要结局

Patient Health Questionnaire (PHQ-9)

时间窗: Baseline, 4-Week Follow-Up, and 9-Week Follow-Up

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.

Sheehan Disability Scale (SDS)

时间窗: Baseline, 4-Week Follow-Up and 9-Week Follow-Up

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.

Generalized Anxiety Disorder (GAD-7)

时间窗: Baseline, 4-Week Follow-Up, and 9-Week Follow-Up

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.

次要结局

  • University of California Los Angeles (UCLA) Loneliness Scale(Baseline, 4-Week Follow-Up, and 9-Week Follow-Up)
  • Intervention Appropriateness Measure (IAM)(Baseline, 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.)
  • Intervention Usability Scale (IUS)(9 weeks)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Pullmann

Research Associate Professor, Department of Psychiatry And Behavioral Sciences

University of Washington

研究点 (2)

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