DepressionNCT04966910
Stay Connected: Testing an Intervention to Combat Coronavirus-related Social Isolation Among Older Adults
A study testing Stay Connected and Treatment as usual in people with Depression and Anxiety, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression, Anxiety, Loneliness
- What is being tested?
- Stay Connected and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 13 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stay Connected: Testing an Intervention to Combat COVID-19 Related Social Isolation Among Seattle-area Older Adults
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.
Read the 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
- Being tested
- Stay Connected, Treatment as usual
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stay ConnectedBehavioural
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 usualBehavioural
Regular check-ins, resource/referral provision
| Study group | Role | What they receive |
|---|---|---|
| Stay Connected | Experimental | Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults Receives: 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 Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 4-Week Follow-Up and 9-Week Follow-Up
Secondary outcomes (6)
University of California Los Angeles (UCLA) Loneliness Scale
A 3-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. Total scores range from 3 - 9, with higher scores indicating higher levels of loneliness.
Measured: Baseline, 4-Week Follow-Up, and 9-Week Follow-Up
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. Total scores range from 0 - 150, with higher scores indicating more behavioral activation.
Measured: 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
The PROMIS Social Isolation item bank assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. This measure consists of 4 items, each rated on a five-point scale ranging from 1 - 5. Older adult participants will complete this measure. Total scores range from 4 - 20, with higher scores meaning more social isolation.
Measured: Baseline, 4-Week Follow-Up, and 9-Week Follow-Up
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, and the total score is a mean item score with minimum score of 1 and maximum of 5. Clinician participants complete this measure. Higher values are considered to be more positive (i.e., a more acceptable intervention).
Measured: Baseline and 9 week follow up
Intervention Usability Scale (IUS)
This is a ten item measure of how easy the intervention/system is to use and learn. Used for interventions (e.g., therapeutic modalities). Total scale scores range from 0 to 100, with higher scores considered to be more positive (i.e., a more usable intervention). Scores of 70 and higher are considered to be a usable intervention. Clinician participants complete this measure.
Measured: 9 weeks
Intervention Appropriateness Measure (IAM)
This is a four item measure of how suitable an intervention is for the circumstances, where each item is rated on a 1-5 scale, with 1 = not at all appropriate and 5 = very appropriate, and the total score is a mean item score with minimum score of 1 and maximum of 5. Clinician participants complete this measure. Higher values are considered to be more positive (i.e., a more appropriate intervention).
Measured: Baseline, 9 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start9 Apr 2021
- Primary completion13 Jun 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Michael Pullmann, University of Washington
- Investigators
- Patricia Arean, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966910
- Sponsor's protocol ID
- STUDY00011051
- Other IDs
- 5P50MH115837-03
- Status last verified
- Apr 2024
- First submitted
- 25 Jun 2021
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stay Connected: Testing an Intervention to Combat COVID-19 Related Social Isolation Among Seattle-area Older Adults
- ClinicalTrials.gov ID
- NCT04966910
- Acronym / sponsor ID
- STUDY00011051
- Conditions
- Depression, Anxiety, Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Posted 14 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stay Connected | Experimental | Behavioral: Stay ConnectedMenu-driven set of strategies to combat loneliness, anxiety and depression in older adults |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualTreatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stay ConnectedStay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles. | Behavioural | Stay Connected |
| Treatment as usualRegular check-ins, resource/referral provision | Behavioural | Treatment as usual |
Primary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: 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.
Generalized Anxiety Disorder (GAD-7)
Time frame: 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.
Sheehan Disability Scale (SDS)
Time frame: 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.
6 secondary outcomes
University of California Los Angeles (UCLA) Loneliness Scale
Time frame: Baseline, 4-Week Follow-Up, and 9-Week Follow-Up
Behavioral Activation Scale (BADS)
Time frame: 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
Time frame: Baseline, 4-Week Follow-Up, and 9-Week Follow-Up
Acceptability of Intervention Measure (AIM)
Time frame: Baseline and 9 week follow up
Intervention Usability Scale (IUS)
Time frame: 9 weeks
Intervention Appropriateness Measure (IAM)
Time frame: Baseline, 9 week follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Arean, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stay Connected and Treatment as usual in people with Depression and Anxiety, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9) (time frame: Baseline, 4-Week Follow-Up, and 9-Week Follow-Up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.