search
Back to results

Social Connections and Late Life Suicide

Primary Purpose

Depression, Suicidal Ideation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ENGAGE
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ENGAGE: a social engagement intervention

Care-as-Usual

Arm Description

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).

Care as usual in primary care with study assessments.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).

Full Information

First Posted
July 2, 2014
Last Updated
September 10, 2021
Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT02188485
Brief Title
Social Connections and Late Life Suicide
Official Title
Social Connections and Late Life Suicide
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
May 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Suicidal Ideation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ENGAGE: a social engagement intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Care-as-Usual
Arm Type
No Intervention
Arm Description
Care as usual in primary care with study assessments.
Intervention Type
Behavioral
Intervention Name(s)
ENGAGE
Intervention Description
Up to 10 sessions delivered in the home.
Primary Outcome Measure Information:
Title
Social Connectedness
Description
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).
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Suicide Ideation
Description
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).
Time Frame
10 weeks
Title
Depression
Description
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).
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly A Van Orden, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Van Orden, K. A., et al.
Results Reference
result

Learn more about this trial

Social Connections and Late Life Suicide

We'll reach out to this number within 24 hrs