Social Connections and Late Life Suicide

NCT02188485 | Completed Results DMC

• 1 other identifier: K23MH096936
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Suicide Ideation

  10 weeks

• Depression

  10 weeks

Study Arms (2)

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).

Behavioral: ENGAGE

Care-as-Usual

NO INTERVENTION

Care as usual in primary care with study assessments.

Interventions

ENGAGE BEHAVIORAL

Up to 10 sessions delivered in the home.

ENGAGE: a social engagement intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Van Orden, K. A., et al.

  RESULT

MeSH Terms

Conditions

Depression; Suicidal Ideation

Interventions

engage 8200

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

Limitations and Caveats

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.

Results Point of Contact

• Title: Kim Van Orden, PhD
• Organization: University of Rochester

kimberly_vanorden@urmc.rochester.edu

585-275-5176

Study Officials

• Kimberly A Van Orden, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 11, 2014
• Study Start: January 1, 2015
• Primary Completion: May 30, 2017
• Study Completion: May 30, 2017
• Last Updated: October 7, 2021
• Results First Posted: October 7, 2021

Record last verified: 2021-09

Locations

US (1)