Social Connections and Late Life Suicide

Depression Clinical Trial

Official title:

Social Connections and Late Life Suicide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188485
• Other study ID #: K23MH096936
• Secondary ID: K23MH096936
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: May 30, 2017

Study information

• Verified date: September 2021
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Suicidal Ideation
• Suicide

Intervention

Behavioral:
• ENGAGE
Up to 10 sessions delivered in the home.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Van Orden, K. A., et al.

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	10 weeks
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).	10 weeks
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).	10 weeks

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