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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH096936 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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With the long-term goal of improving interventions for late-life suicide, the purpose of this study is to examine whether a mechanism by which behavioral interventions reduce risk for late-life suicide is by increasing social connectedness. The investigators propose to examine whether a manualized intervention that targets connectedness--ENGAGE--increases connectedness in older adults who report clinically significant depression and disconnectedness-operationalized as feeling lonely and/or like a burden on others. The investigators propose a randomized controlled trial comparing the ENGAGE intervention with care-as-usual (CAU), using n=100 primary care patients aged ≥ 60 years who report social disconnectedness (i.e., loneliness or burdensomeness) and either Minor or Major Depression. At baseline, 3-week, 6-week and 10-week assessments, subjects will report on social connectedness, depression, and suicide risk. The investigators hypothesize that those subjects assigned to ENGAGE will report greater increases in connectedness-measured as greater belongingness and lower burdensomeness-compared to CAU; that ENGAGE will produce greater reductions in depression and suicide ideation than CAU; and that changes in depression will be accounted for changes in social connectedness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENGAGE: a social engagement intervention | Experimental | ENGAGE is a brief psychotherapy that specifically targets increased social engagement and activity. The study will use the ENGAGE manual developed by Drs. Alexopoulos, Arean and their colleagues, focusing on increased engagement in activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the well-being of others (targeting perceived burdensomeness). |
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| Care-as-Usual | No Intervention | Care as usual in primary care with study assessments. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENGAGE | Behavioral | Up to 10 sessions delivered in the home. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Social Connectedness | Severity of social disconnectedness at 10 weeks, operationalized as thwarted belongingness and perceived burdensomeness, measured by the Interpersonal Needs Questionnaire. Scores on the thwarted belonging subscale range from 0-18, with greater scores indicating greater thwarted belonging (i.e., worse outcome). Scores on the perceived burden subscale range from 0-12, with greater scores indicating greater perceived burden on others (i.e., worse outcome). | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Suicide Ideation | Suicide ideation at 10 weeks, measured by the Geriatric Suicide ideation scale, with scores ranging from 4 to 20, with greater scores indicating greater suicide ideation (i.e., worse outcome). | 10 weeks |
| Depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly A Van Orden, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Van Orden, K. A., et al. |
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Eligibility criteria were assessed at a baseline interview prior to randomization.
Participants were recruited from primary care and an outpatient geriatric psychiatry clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | ENGAGE: a Social Engagement Intervention | ENGAGE is a brief psychotherapy that specifically targets increased social engagement and activity. The study will use the ENGAGE manual developed by Drs. Alexopoulos, Arean and their colleagues, focusing on increased engagement in activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the well-being of others (targeting perceived burdensomeness). ENGAGE: Up to 10 sessions delivered in the home. |
| FG001 | Care-as-Usual | Care as usual in primary care with study assessments. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ENGAGE: a Social Engagement Intervention | ENGAGE is a brief psychotherapy that specifically targets increased social engagement and activity. The study will use the ENGAGE manual developed by Drs. Alexopoulos, Arean and their colleagues, focusing on increased engagement in activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the well-being of others (targeting perceived burdensomeness). ENGAGE: Up to 10 sessions delivered in the home. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Social Connectedness | Severity of social disconnectedness at 10 weeks, operationalized as thwarted belongingness and perceived burdensomeness, measured by the Interpersonal Needs Questionnaire. Scores on the thwarted belonging subscale range from 0-18, with greater scores indicating greater thwarted belonging (i.e., worse outcome). Scores on the perceived burden subscale range from 0-12, with greater scores indicating greater perceived burden on others (i.e., worse outcome). | Posted | Mean | Standard Deviation | score on scale | 10 weeks |
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Participant engagement in the study (i.e., 10 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ENGAGE: a Social Engagement Intervention | ENGAGE is a brief psychotherapy that specifically targets increased social engagement and activity. The study will use the ENGAGE manual developed by Drs. Alexopoulos, Arean and their colleagues, focusing on increased engagement in activities that allow subjects to be social (targeting thwarted belongingness) or contribute to the well-being of others (targeting perceived burdensomeness). ENGAGE: Up to 10 sessions delivered in the home. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric hospitalization | Psychiatric disorders | Systematic Assessment |
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The primary limitation was the sample size that was underpowered to detect small changes in target mechanisms and suicide ideation. A lack of assessment of social engagement in both groups limited our ability to fully examine this potential target mechanism. Aspects of the study design that increase generalizability to the population of interest also created a heterogenous sample with regards to functioning and contributors to disconnection that may reduce precision for detecting effects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kim Van Orden, PhD | University of Rochester | 585-275-5176 | kimberly_vanorden@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2016 | Sep 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
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| ID | Term |
|---|---|
| C470748 | engage 8200 |
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Depression severity was measured with the Quick Inventory of Depressive Symptomatology (QIDS), interviewer rated version, with scores ranging from 0 to 27, with higher scores indicating greater depression (worse outcomes).
| 10 weeks |
| BG001 | Care-as-Usual | Care as usual in primary care with study assessments. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Depression Symptom Severity | Depression severity was measured with the 16-item Quick Inventory of Depressive Symptomatology (QIDS), interviewer rated version, with scores ranging from 0 to 27, with higher scores indicating greater depression (worse outcomes). | Mean | Standard Deviation | units on a scale |
|
| Low Belonging (INQ-TB) | Thwarted (low) belonging was measured by the Interpersonal Needs Questionnaire, thwarted belonging subscale (INQ-TB). Scores on the thwarted belonging subscale range from 0-18, with greater scores indicating greater thwarted belonging (i.e., worse outcome). | Mean | Standard Deviation | units on a scale |
|
| Perceived burden (INQ-PB) | Perceived burdensomeness was measured by the Interpersonal Needs Questionnaire Perceived Burden subscale (INQ-PB). Scores on the perceived burden subscale range from 0-12, with greater scores indicating greater perceived burden on others (i.e., worse outcome). | Mean | Standard Deviation | units on a scale |
|
| Suicide Ideation (GSIS) | Suicide ideation was measured by the Geriatric Suicide ideation scale, with scores ranging from 4 to 20, with greater scores indicating greater suicide ideation (i.e., worse outcome). | Mean | Standard Deviation | units on a scale |
|
| OG001 | Care-as-Usual | Care as usual in primary care with study assessments. |
|
|
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| Secondary | Suicide Ideation | Suicide ideation at 10 weeks, measured by the Geriatric Suicide ideation scale, with scores ranging from 4 to 20, with greater scores indicating greater suicide ideation (i.e., worse outcome). | Posted | Mean | Standard Deviation | score on a scale | 10 weeks |
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| Secondary | Depression | Depression severity was measured with the Quick Inventory of Depressive Symptomatology (QIDS), interviewer rated version, with scores ranging from 0 to 27, with higher scores indicating greater depression (worse outcomes). | Posted | Mean | Standard Deviation | score on a scale | 10 weeks |
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| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Care-as-Usual | Care as usual in primary care with study assessments. | 0 | 30 | 2 | 30 | 0 | 30 |
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