Social Connections and Late Life Suicide
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ClinicalTrials.gov Identifier: NCT02188485 |
Recruitment Status :
Completed
First Posted : July 11, 2014
Last Update Posted : July 11, 2017
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Condition or disease | Intervention/treatment | Phase |
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Depression Suicidal Ideation | Behavioral: ENGAGE | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Social Connections and Late Life Suicide |
Actual Study Start Date : | January 2015 |
Actual Primary Completion Date : | May 30, 2017 |
Actual Study Completion Date : | May 30, 2017 |

Arm | Intervention/treatment |
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Experimental: 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).
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Behavioral: ENGAGE
Up to 10 sessions delivered in the home. |
No Intervention: Care-as-Usual
Care as usual in primary care with study assessments.
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- Social connectedness [ Time Frame: 3 weeks, 6 weeks, 10 weeks. ]Change from baseline in severity of social disconnectedness at 3 weeks, 6 weeks, and 10 weeks, operationalized as thwarted belongingness and perceived burdensomeness, measured by the Interpersonal Needs Questionnaire (Van Orden et al., 2012).
- Suicide ideation [ Time Frame: 3 weeks, 6 weeks, 10 weeks ]Change from baseline in suicide ideation at 3 weeks, 6 weeks, and 10 weeks, measured by the Geriatric Suicide ideation scale (Heisel & Flett, 2005).
- Depression [ Time Frame: 3 weeks, 6 weeks, 10 weeks ]Change in depression severity from baseline at 3 weeks, 6 weeks, and 10 weeks. Depression severity will be measured with the Quick Inventory of Depressive Symptomatology (QIDS).

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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 60 yrs;
- English speaking;
- Reside in the community;
- Endorse social disconnectedness, as measured by feeling lonely and/or like a burden on others;
- Meet criteria for Minor or Major Depression.
Exclusion Criteria:
- Imminent risk for suicide;
- Active psychosis;
- Significantly impaired cognitive functioning (i.e., MOCA <23);
- Active substance abuse in the last year (AUDIT score of 5 or more);
- Hearing loss that precludes comfortable communication;
- Residence in a long-term care facility.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188485
United States, New York | |
University of Rochester | |
Rochester, New York, United States, 14642 |
Principal Investigator: | Kimberly A Van Orden, PhD | University of Rochester |
Responsible Party: | Kimberly Van Orden, Assistant Professor, University of Rochester |
ClinicalTrials.gov Identifier: | NCT02188485 |
Other Study ID Numbers: |
K23MH096936 ( U.S. NIH Grant/Contract ) K23MH096936 ( U.S. NIH Grant/Contract ) |
First Posted: | July 11, 2014 Key Record Dates |
Last Update Posted: | July 11, 2017 |
Last Verified: | July 2017 |
Suicide Suicidal Ideation Behavioral Symptoms Self-Injurious Behavior |