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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

Tracking Information
First Submitted Date  ICMJE July 2, 2014
First Posted Date  ICMJE July 11, 2014
Last Update Posted Date July 11, 2017
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date May 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2014)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2014)
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
  • Social connectedness [ Time Frame: 3 weeks, 6 weeks, 10 weeks ]
    Change from baseline in thwarted belongingness and perceived burdensomeness at 3 weeks, 6 weeks, and 10 weeks. Thwarted belongingness and perceived burdensomeness will be measured with the Interpersonal Needs Questionnaire (Van Orden et al., 2012)
  • Suicide ideation [ Time Frame: 3 weeks, 6 weeks, 10 weeks ]
    Change from baseline in severity of passive suicide ideation at 3 weeks, 6 weeks, and 10 weeks. Suicide ideation will be measured with the Geriatric Suicide Ideation Scale (Heisel & Flett, 2005).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Social Connections and Late Life Suicide
Official Title  ICMJE Social Connections and Late Life Suicide
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Suicidal Ideation
Intervention  ICMJE Behavioral: ENGAGE
Up to 10 sessions delivered in the home.
Study Arms  ICMJE
  • 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).
    Intervention: Behavioral: ENGAGE
  • No Intervention: Care-as-Usual
    Care as usual in primary care with study assessments.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2017)
62
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2014)
100
Actual Study Completion Date  ICMJE May 30, 2017
Actual Primary Completion Date May 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188485
Other Study ID Numbers  ICMJE K23MH096936( U.S. NIH Grant/Contract )
K23MH096936 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kimberly Van Orden, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Kimberly A Van Orden, PhD University of Rochester
PRS Account University of Rochester
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP