Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5P50MH115837-03 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stay Connected | Experimental | Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults |
|
| Treatment as usual | Active Comparator | Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Older Adult Participants
Inclusion Criteria:
Exclusion Criteria:
Staff Participants Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patricia Arean, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stay Connected Clients | Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults 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. This group is for the clients who received the intervention. |
| FG001 | Usual Care Clients | Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals Treatment as usual: Regular check-ins, resource/referral provision. This group is for the clients who received treatment as usual. |
| FG002 | Stay Connected Clinicians | Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults 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. This group is for the clinicians who delivered the intervention. |
| FG003 | Usual Care Staff | Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals Treatment as usual: Regular check-ins, resource/referral provision. This group is for the clinicians who delivered treatment as usual. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
|
| ||||||||||||||||||
| 4-Week Follow-Up |
| |||||||||||||||||||
| 9-Week Follow-Up |
|
Participants contributing demographic data. While more participants provided outcome measures at baseline, several participants did not respond to the demographic questions at baseline.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Stay Connected Clients | Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 1 participant in the Usual Care arm did not contribute age data within the analytic sample. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4-Week Follow-Up, and 9-Week Follow-Up |
|
Adverse events were collected for the entirety of time patients were in the study from baseline to 9 week follow-up.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stay Connected Clients | Clients receiving a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Pullmann | University of Washington | 206-685-0408 | pullmann@uw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 11, 2021 | May 23, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 11, 2021 | May 24, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2021 | May 23, 2023 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Treatment as usual | Behavioral | Regular check-ins, resource/referral provision |
|
| 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. | 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. | 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). | 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. | 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). | Baseline, 9 week follow up |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Usual Care Clients |
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals Treatment as usual: Regular check-ins, resource/referral provision |
| BG002 | Stay Connected Clinicians | Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults 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. This group is the clinicians who delivered the Stay Connected intervention. |
| BG003 | Usual Care Clinicians | Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals Treatment as usual: Regular check-ins, resource/referral provision. this group is the clinicians who delivered usual care. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Clinicians were not asked about their sex | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| OG001 | Usual Care Clients | Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals Treatment as usual: Regular check-ins, resource/referral provision |
|
|
|
| Primary | 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. | Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4-Week Follow-Up, and 9-Week Follow-Up |
|
|
|
|
| Primary | 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. | Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4-Week Follow-Up and 9-Week Follow-Up |
|
|
|
|
| Secondary | 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. | Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4-Week Follow-Up, and 9-Week Follow-Up |
|
|
|
|
| Secondary | 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. | Participants contributing data at Baseline, 4-Week Follow-Up and 9-Week Follow-Up | Posted | Mean | Standard Deviation | score on a scale | Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint. |
|
|
|
|
| Secondary | 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. | Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4-Week Follow-Up, and 9-Week Follow-Up |
|
|
|
|
| Secondary | 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). | Both Clinicians who delivered Usual Care dropped out of the study after baseline assessment. Only one clinician in the Stay Connected group completed baseline assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 9 week follow up |
|
|
|
| Secondary | 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. | Data collected from Stay Connected group at 9 weeks only. | Posted | Mean | Standard Deviation | score on a scale | 9 weeks |
|
|
|
| Secondary | 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). | Only clinicians were administered the measure. Both usual care clinicians dropped out of the study after baseline. Only 1 clinician in the Stay Connected group responded at baseline. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 9 week follow up |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Usual Care Clients | Clients receiving treatment as usual in these practice settings, typically including regular check-in calls and offering resources and referrals | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | Stay Connected Clinicians | Clinicians delivering a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | Usual Care Clinicians | Clinicians delivering treatment as usual in these practice settings, typically including regular check-in calls and offering resources and referrals | 0 | 2 | 0 | 2 | 0 | 2 |
Not provided
Not provided
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Some college, no degree |
|
| Associate degree |
|
| Bachelors degree |
|
| Masters degree |
|
| Professional or doctorate |
|
| 9-Week Follow-Up |
|
| 9-Week Follow-Up |
|
| 9-Week Follow-Up |
|
| 9-Week Follow-Up |
|
| 9-Week Follow-Up |
|
| 9 week follow up |
|
|
| 9 weeks |
|
|