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Social Connections and Late Life Suicide

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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.



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).



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188485


Locations
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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
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Principal Investigator: Kimberly A Van Orden, PhD University of Rochester
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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    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Suicide
Suicidal Ideation
Behavioral Symptoms
Self-Injurious Behavior