Social Connections and Late Life Suicide

NCT ID: NCT02188485

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-05-30

Brief Summary

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.

Conditions

Depression; Suicidal Ideation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

ENGAGE

Intervention Type: BEHAVIORAL

Up to 10 sessions delivered in the home.

Care-as-Usual

Care as usual in primary care with study assessments.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ENGAGE

Up to 10 sessions delivered in the home.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Kimberly Van Orden

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimberly A Van Orden, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

References

Van Orden, K. A., et al.

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K23MH096936

Identifier Type: NIH

Identifier Source: secondary_id

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K23MH096936

Identifier Type: NIH

Identifier Source: org_study_id

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