Social Connections and Late Life Suicide

• ClinicalTrials.gov Identifier: NCT02188485
• Recruitment Status: Completed
• First Posted: July 11, 2014
• Last Update Posted: July 11, 2017
• Sponsor: University of Rochester
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Kimberly Van Orden, University of Rochester

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Depression; Suicidal Ideation	Behavioral: ENGAGE	Not Applicable

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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).
2. 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).

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, New York

University of Rochester

Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Kimberly A Van Orden, PhD; University of Rochester

More Information

• 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
• Last Update Posted: July 11, 2017
• Last Verified: July 2017

Additional relevant MeSH terms:

Suicide; Suicidal Ideation; Behavioral Symptoms; Self-Injurious Behavior