Depression, Suicidal Ideation
Conditions
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.
Interventions
BEHAVIORALENGAGE
Up to 10 sessions delivered in the home.
Sponsors
National Institute of Mental Health (NIMH)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from primary care and an outpatient geriatric psychiatry clinic.
Pre-assignment details
Eligibility criteria were assessed at a baseline interview prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| Care-as-Usual Care as usual in primary care with study assessments. | 30 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | PI withdrew, lack of capacity | 0 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | ENGAGE: a Social Engagement Intervention | Care-as-Usual | Total |
|---|---|---|---|
| Age, Continuous | 72.78 years STANDARD_DEVIATION 9.27 | 71.46 years STANDARD_DEVIATION 8.96 | 72 years STANDARD_DEVIATION 9.07 |
| Depression Symptom Severity | 8.41 units on a scale STANDARD_DEVIATION 4.32 | 7.37 units on a scale STANDARD_DEVIATION 5.26 | 7.90 units on a scale STANDARD_DEVIATION 4.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 30 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Low Belonging (INQ-TB) | 6.47 units on a scale STANDARD_DEVIATION 3.69 | 5.97 units on a scale STANDARD_DEVIATION 4.11 | 6.23 units on a scale STANDARD_DEVIATION 3.87 |
| Perceived burden (INQ-PB) | 1.25 units on a scale STANDARD_DEVIATION 1.98 | 1.23 units on a scale STANDARD_DEVIATION 1.98 | 1.25 units on a scale STANDARD_DEVIATION 1.98 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 31 Participants | 26 Participants | 57 Participants |
| Region of Enrollment United States | 32 participants | 30 participants | 62 participants |
| Sex: Female, Male Female | 22 Participants | 20 Participants | 42 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
| Suicide Ideation (GSIS) | 7.81 units on a scale STANDARD_DEVIATION 3.27 | 7.77 units on a scale STANDARD_DEVIATION 3.14 | 7.79 units on a scale STANDARD_DEVIATION 3.18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 30 |
| other Total, other adverse events | 0 / 32 | 0 / 30 |
| serious Total, serious adverse events | 0 / 32 | 2 / 30 |
Outcome results
Primary
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).
Time frame: 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ENGAGE: a Social Engagement Intervention | Social Connectedness | Thwarted Belonging (INQ) | 4.33 score on scale | Standard Deviation 3.49 |
| ENGAGE: a Social Engagement Intervention | Social Connectedness | Perceived burden (INQ | 0.77 score on scale | Standard Deviation 1.92 |
| Care-as-Usual | Social Connectedness | Thwarted Belonging (INQ) | 4.30 score on scale | Standard Deviation 4.3 |
| Care-as-Usual | Social Connectedness | Perceived burden (INQ | 0.82 score on scale | Standard Deviation 1.8 |
Comparison: Thwarted belonging (INQ-TB) at 10 week follow-upp-value: 0.278Mixed Models Analysis
Comparison: Perceived burden (INQ-PB) at 10-week follow-upp-value: 0.591Mixed Models Analysis
Secondary
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).
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ENGAGE: a Social Engagement Intervention | Depression | 5.37 score on a scale | Standard Deviation 3.63 |
| Care-as-Usual | Depression | 6.15 score on a scale | Standard Deviation 4.81 |
p-value: 0.014Mixed Models Analysis
Secondary
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).
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ENGAGE: a Social Engagement Intervention | Suicide Ideation | 6.6 score on a scale | Standard Deviation 2.93 |
| Care-as-Usual | Suicide Ideation | 6.56 score on a scale | Standard Deviation 3.36 |
p-value: 0.511Mixed Models Analysis