Social Connections and Late Life Suicide

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.

Study Overview

• Status: Completed
• Conditions: Depression; Suicidal Ideation
• Intervention / Treatment: Behavioral: ENGAGE

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Behavioral: ENGAGE; Up to 10 sessions delivered in the home.
No Intervention: Care-as-Usual; Care as usual in primary care with study assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Kimberly A Van Orden, PhD, University of Rochester

Publications and helpful links

General Publications

• Van Orden, K. A., et al.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): May 30, 2017
• Study Completion (Actual): May 30, 2017

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 11, 2014

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: K23MH096936 (U.S. NIH Grant/Contract)