Trial Outcomes & Findings for Social Connections and Late Life Suicide (NCT NCT02188485)
NCT ID: NCT02188485
Last Updated: 2021-10-07
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
10 weeks
Results posted on
2021-10-07
Participant Flow
Participants were recruited from primary care and an outpatient geriatric psychiatry clinic.
Eligibility criteria were assessed at a baseline interview prior to randomization.
Participant milestones
| Measure |
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).
ENGAGE: Up to 10 sessions delivered in the home.
|
Care-as-Usual
Care as usual in primary care with study assessments.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
30
|
|
Overall Study
COMPLETED
|
30
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
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).
ENGAGE: Up to 10 sessions delivered in the home.
|
Care-as-Usual
Care as usual in primary care with study assessments.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
PI withdrew, lack of capacity
|
0
|
2
|
Baseline Characteristics
Social Connections and Late Life Suicide
Baseline characteristics by cohort
| Measure |
ENGAGE: a Social Engagement Intervention
n=32 Participants
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).
ENGAGE: Up to 10 sessions delivered in the home.
|
Care-as-Usual
n=30 Participants
Care as usual in primary care with study assessments.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.78 years
STANDARD_DEVIATION 9.27 • n=5 Participants
|
71.46 years
STANDARD_DEVIATION 8.96 • n=7 Participants
|
72 years
STANDARD_DEVIATION 9.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
30 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Depression Symptom Severity
|
8.41 units on a scale
STANDARD_DEVIATION 4.32 • n=5 Participants
|
7.37 units on a scale
STANDARD_DEVIATION 5.26 • n=7 Participants
|
7.90 units on a scale
STANDARD_DEVIATION 4.79 • n=5 Participants
|
|
Low Belonging (INQ-TB)
|
6.47 units on a scale
STANDARD_DEVIATION 3.69 • n=5 Participants
|
5.97 units on a scale
STANDARD_DEVIATION 4.11 • n=7 Participants
|
6.23 units on a scale
STANDARD_DEVIATION 3.87 • n=5 Participants
|
|
Perceived burden (INQ-PB)
|
1.25 units on a scale
STANDARD_DEVIATION 1.98 • n=5 Participants
|
1.23 units on a scale
STANDARD_DEVIATION 1.98 • n=7 Participants
|
1.25 units on a scale
STANDARD_DEVIATION 1.98 • n=5 Participants
|
|
Suicide Ideation (GSIS)
|
7.81 units on a scale
STANDARD_DEVIATION 3.27 • n=5 Participants
|
7.77 units on a scale
STANDARD_DEVIATION 3.14 • n=7 Participants
|
7.79 units on a scale
STANDARD_DEVIATION 3.18 • n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksSeverity 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).
Outcome measures
| Measure |
ENGAGE: a Social Engagement Intervention
n=30 Participants
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).
ENGAGE: Up to 10 sessions delivered in the home.
|
Care-as-Usual
n=27 Participants
Care as usual in primary care with study assessments.
|
|---|---|---|
|
Social Connectedness
Thwarted Belonging (INQ)
|
4.33 score on scale
Standard Deviation 3.49
|
4.30 score on scale
Standard Deviation 4.30
|
|
Social Connectedness
Perceived burden (INQ
|
0.77 score on scale
Standard Deviation 1.92
|
0.82 score on scale
Standard Deviation 1.80
|
SECONDARY outcome
Timeframe: 10 weeksSuicide 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).
Outcome measures
| Measure |
ENGAGE: a Social Engagement Intervention
n=30 Participants
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).
ENGAGE: Up to 10 sessions delivered in the home.
|
Care-as-Usual
n=27 Participants
Care as usual in primary care with study assessments.
|
|---|---|---|
|
Suicide Ideation
|
6.6 score on a scale
Standard Deviation 2.93
|
6.56 score on a scale
Standard Deviation 3.36
|
SECONDARY outcome
Timeframe: 10 weeksDepression 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).
Outcome measures
| Measure |
ENGAGE: a Social Engagement Intervention
n=30 Participants
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).
ENGAGE: Up to 10 sessions delivered in the home.
|
Care-as-Usual
n=27 Participants
Care as usual in primary care with study assessments.
|
|---|---|---|
|
Depression
|
5.37 score on a scale
Standard Deviation 3.63
|
6.15 score on a scale
Standard Deviation 4.81
|
Adverse Events
ENGAGE: a Social Engagement Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Care-as-Usual
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ENGAGE: a Social Engagement Intervention
n=32 participants at risk
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).
ENGAGE: Up to 10 sessions delivered in the home.
|
Care-as-Usual
n=30 participants at risk
Care as usual in primary care with study assessments.
|
|---|---|---|
|
Psychiatric disorders
Psychiatric hospitalization
|
0.00%
0/32 • Participant engagement in the study (i.e., 10 weeks)
|
6.7%
2/30 • Number of events 2 • Participant engagement in the study (i.e., 10 weeks)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place