Social Connections and Late Life Suicide

Sponsor
University of Rochester (Other)
Overall Status
Completed
CT.gov ID
NCT02188485
Collaborator
National Institute of Mental Health (NIMH) (NIH)
62
Enrollment
1
Location
2
Arms
28.9
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

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 DiseaseIntervention/TreatmentPhase
  • Behavioral: ENGAGE
N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2015
Actual Primary Completion Date :
May 30, 2017
Actual Study Completion Date :
May 30, 2017

Arms and Interventions

ArmIntervention/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 [10 weeks]

    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

  1. Suicide Ideation [10 weeks]

    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).

  2. Depression [10 weeks]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

SiteCityStateCountryPostal Code
1University of RochesterRochesterNew YorkUnited States14642

Sponsors and Collaborators

  • University of Rochester
  • National Institute of Mental Health (NIMH)

Investigators

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

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Kimberly Van Orden, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier:
NCT02188485
Other Study ID Numbers:
  • K23MH096936
  • K23MH096936
First Posted:
Jul 11, 2014
Last Update Posted:
Oct 7, 2021
Last Verified:
Sep 1, 2021
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsParticipants were recruited from primary care and an outpatient geriatric psychiatry clinic.
Pre-assignment DetailEligibility criteria were assessed at a baseline interview prior to randomization.
Arm/Group TitleENGAGE: a Social Engagement InterventionCare-as-Usual
Arm/Group DescriptionENGAGE 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). ENGAGE: Up to 10 sessions delivered in the home.Care as usual in primary care with study assessments.
Period Title: Overall Study
STARTED3230
COMPLETED3027
NOT COMPLETED23

Baseline Characteristics

Arm/Group TitleENGAGE: a Social Engagement InterventionCare-as-UsualTotal
Arm/Group DescriptionENGAGE 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). ENGAGE: Up to 10 sessions delivered in the home.Care as usual in primary care with study assessments.Total of all reporting groups
Overall Participants323062
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
72.78
(9.27)
71.46
(8.96)
72
(9.07)
Sex: Female, Male (Count of Participants)
Female
22
68.8%
20
66.7%
42
67.7%
Male
10
31.3%
10
33.3%
20
32.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
0
0%
0
0%
Not Hispanic or Latino
32
100%
30
100%
62
100%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
1
3.3%
1
1.6%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
1
3.1%
2
6.7%
3
4.8%
White
31
96.9%
26
86.7%
57
91.9%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
1
3.3%
1
1.6%
Region of Enrollment (participants) [Number]
United States
32
100%
30
100%
62
100%
Depression Symptom Severity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
8.41
(4.32)
7.37
(5.26)
7.90
(4.79)
Low Belonging (INQ-TB) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
6.47
(3.69)
5.97
(4.11)
6.23
(3.87)
Perceived burden (INQ-PB) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
1.25
(1.98)
1.23
(1.98)
1.25
(1.98)
Suicide Ideation (GSIS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
7.81
(3.27)
7.77
(3.14)
7.79
(3.18)

Outcome Measures

1. Primary Outcome
TitleSocial Connectedness
DescriptionSeverity 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 Frame10 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleENGAGE: a Social Engagement InterventionCare-as-Usual
Arm/Group DescriptionENGAGE 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). ENGAGE: Up to 10 sessions delivered in the home.Care as usual in primary care with study assessments.
Measure Participants3027
Thwarted Belonging (INQ)
4.33
(3.49)
4.30
(4.30)
Perceived burden (INQ
0.77
(1.92)
0.82
(1.80)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ENGAGE: a Social Engagement Intervention, Care-as-Usual
Comments Thwarted belonging (INQ-TB) at 10 week follow-up
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value.278
Comments
MethodMixed Models Analysis
Comments
Method of EstimationEstimation ParameterMean Difference (Final Values)
Estimated Value-.79
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: .72
Estimation CommentsThis mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ENGAGE: a Social Engagement Intervention, Care-as-Usual
Comments Perceived burden (INQ-PB) at 10-week follow-up
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value.591
Comments
MethodMixed Models Analysis
Comments
Method of EstimationEstimation ParameterMean Difference (Final Values)
Estimated Value-.20
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: .38
Estimation CommentsThis mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.
2. Secondary Outcome
TitleSuicide Ideation
DescriptionSuicide 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 Frame10 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleENGAGE: a Social Engagement InterventionCare-as-Usual
Arm/Group DescriptionENGAGE 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). ENGAGE: Up to 10 sessions delivered in the home.Care as usual in primary care with study assessments.
Measure Participants3027
Mean (Standard Deviation) [score on a scale]
6.6
(2.93)
6.56
(3.36)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ENGAGE: a Social Engagement Intervention, Care-as-Usual
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value.511
Comments
MethodMixed Models Analysis
Comments
Method of EstimationEstimation ParameterMean Difference (Final Values)
Estimated Value-.34
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: .52
Estimation CommentsThis mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.
3. Secondary Outcome
TitleDepression
DescriptionDepression 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 Frame10 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleENGAGE: a Social Engagement InterventionCare-as-Usual
Arm/Group DescriptionENGAGE 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). ENGAGE: Up to 10 sessions delivered in the home.Care as usual in primary care with study assessments.
Measure Participants3027
Mean (Standard Deviation) [score on a scale]
5.37
(3.63)
6.15
(4.81)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ENGAGE: a Social Engagement Intervention, Care-as-Usual
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value.014
Comments
MethodMixed Models Analysis
Comments
Method of EstimationEstimation ParameterMean Difference (Final Values)
Estimated Value-2.47
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: .85
Estimation CommentsThis mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.

Adverse Events

Time FrameParticipant engagement in the study (i.e., 10 weeks)
Adverse Event Reporting Description
Arm/Group TitleENGAGE: a Social Engagement InterventionCare-as-Usual
Arm/Group DescriptionENGAGE 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). ENGAGE: Up to 10 sessions delivered in the home.Care as usual in primary care with study assessments.
All Cause Mortality
ENGAGE: a Social Engagement InterventionCare-as-Usual
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/32 (0%) 0/30 (0%)
Serious Adverse Events
ENGAGE: a Social Engagement InterventionCare-as-Usual
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/32 (0%) 2/30 (6.7%)
Psychiatric disorders
Psychiatric hospitalization0/32 (0%) 02/30 (6.7%) 2
Other (Not Including Serious) Adverse Events
ENGAGE: a Social Engagement InterventionCare-as-Usual
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/32 (0%) 0/30 (0%)

Limitations/Caveats

The primary limitation was the sample size that was underpowered to detect small changes in target mechanisms and suicide ideation. A lack of assessment of social engagement in both groups limited our ability to fully examine this potential target mechanism. Aspects of the study design that increase generalizability to the population of interest also created a heterogenous sample with regards to functioning and contributors to disconnection that may reduce precision for detecting effects.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleKim Van Orden, PhD
OrganizationUniversity of Rochester
Phone585-275-5176
Emailkimberly_vanorden@urmc.rochester.edu
Responsible Party:
Kimberly Van Orden, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier:
NCT02188485
Other Study ID Numbers:
  • K23MH096936
  • K23MH096936
First Posted:
Jul 11, 2014
Last Update Posted:
Oct 7, 2021
Last Verified:
Sep 1, 2021