Depression
Conditions
Brief summary
Fifteen to twenty percent of older Americans (6 to 8 million people) suffer from depression but more than one-half do not receive any services, a burden disproportionately shared by low-income and minority older adults who receive few or no services. The investigators propose to test a community-based peer model of depression care called PEERS (a peer support program) that provides self-care support for minority and low-income older adults.
Detailed description
Depression is a major burden for minority and low-income older adults who are less likely to use mental health services, and development of new service delivery models is needed to improve the quality of life and address disparities to access for this group. The investigators propose to test the effectiveness of a peer-delivered depression care program that is embedded in the community and linked to the patient's primary care clinic. The investigators will carry out a randomized controlled trial of the PEERS program in which peer mentors who have personal experience of depression meet individually with older adults recruited in the community for 8 weekly meetings focused on relief of depressive symptoms through self-care support and linkages to community resources. This group of low-income and minority older adults in the intervention will be compared to a group that receives non-peer visits that provide social interaction. The PEERS program takes a chronic disease self-management approach and is guided by the conceptual frameworks of social support, peer support, and social learning. The investigators will conduct an analysis of mediation to understand the mechanism of peer support, by measuring factors such as self-efficacy and loneliness that may be responsible for the intervention effect. The investigators' goal is to use peer-delivered depression care to decrease the mental health morbidity of at-risk low-income and minority adults. The potential public health impact is high because the investigators' project seeks to increase access to depression for a vulnerable group of older adults who often do not get care and leverages an existing workforce of peer workers whose services are reimbursed in many states.
Interventions
BEHAVIORALPEERS
Peer mentors deliver depression care that include social support and coping skills, focused on goal setting and small behavioral changes.
OTHERSocial interaction
Study staff will provide a combination of 8 social interaction visits and phone calls to the participants randomized to this condition.
Sponsors
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 50 years and older * depressive symptoms with Patient Health Questionnaire-9 scores ≥ 5 * belong to an underserved population, defined as annual income less than 200% of the federal poverty level ($24,120) and/or self-identified ethnic minority * able to communicate in English * willing to give informed consent.
Exclusion criteria
* meet diagnostic criteria for mania or hypomania * meet diagnostic criteria for psychotic syndrome * meet diagnostic criteria for substance abuse or dependence * acutely suicidal * a score on the Mini-Mental State Examination (MMSE) ≤ 24 * currently taking an antidepressant medication with dosage change in the past 3 months * receiving active psychotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 | Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention | Depression will be assessed with the Patient Health Questionnaire (PHQ)-9. The PHQ-9 score is summed. There are 9 items in the questionnaire and scores range from 0 to 27. A score of 5 indicates mild depressive symptoms, 10 - 14 indicates moderate depression, 15-19 indicates moderately severe depression, 20-27 indicates severe depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rand Health Survey Short Form 36 Item - Social Functioning | Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention | The RAND 36-Item Health Survey is a set of generic, coherent, and easily administered quality-of-life measures. Each item is scored on a 0 to 100 range. Higher scores indicate better functioning. The social functioning subscale was calculated using the average of 2 of the 36 items (item 20, 32) |
| Rand Health Survey Short Form 36 Item - Emotional Functioning | Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention | The RAND 36-Item Health Survey is a set of generic, coherent, and easily administered quality-of-life measures. Each item is scored on a 0 to 100 range. Higher scores indicate better functioning. The emotional functioning subscale was calculated using the average of 3 of the 36 items (item 17, 18, 19) |
| Cornell Health Service Index - ER Service Use | Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention | Health service use is measured with the Cornell Service Index, a questionnaire that includes both clinical and informal community-based health services and has been used in depression care studies among older adults. The index asks whether an individual has used a list of services in the 4 months prior, what type of provider was seen, the site of the service, and reasons for service use. Numbers reported indicate the number of participants who reported hospital and emergency service use at specified timepoints. |
| Engagement - Adherence | Intervention 1-8 weeks | Engagement (adherence) was measured by percentage of attendance of meetings as reported by the peer mentors, with a threshold of 80% of meetings attended. |
| Working Alliance Inventory - Goal | Intervention weeks 1-8 | Working alliance was measured on a weekly basis only in the intervention arm with the Working Alliance Inventory-SF. The survey has 12 items with subscales that measure affective bond, and agreement on tasks and goals and are scored using a Likert scale. The goal subscore was calculated by summing items 1, 6, 8, and 11. The subscale ranges from scores of 4-28, with higher scores indicating better agreement on goals. |
| Rand Health Survey Short Form 36 - Physical Functioning | Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention | The RAND 36-Item Health Survey is a set of generic, coherent, and easily administered quality-of-life measures. Each item is scored on a 0 to 100 range. Higher scores indicate better functioning.The physical functioning subscale was calculated using the average of 10 of the 36 items (item 3, 4, 5, 6, 7, 8, 9, 10, 11, 12) |
| Working Alliance Inventory - Task | Intervention weeks 1-8 | Working alliance was measured on a weekly basis only in the intervention arm with the Working Alliance Inventory-SF. The survey has 12 items with subscales that measure affective bond, and agreement on tasks and goals and are scored using a Likert scale. The task subscore was calculated by summing items 2, 4, 10, and 12. The subscale ranges from 4-28. A higher subscore indicates higher agreement on tasks. |
| UCLA Loneliness Scale | Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention | The 20-item R-UCLA loneliness scale measures one's subjective feelings of loneliness as well as feelings of social isolation. Items are summed to create a score. The scores range from 20-80 and higher scores indicating higher level of loneliness. A total score of 20-34 represents low degree of loneliness; 35-49 represent moderate degree of loneliness; 50-64 represent moderately high degree of loneliness; and 65 or above represent high degree of loneliness. |
| General Self-Efficacy Scale | Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention | The General Self-Efficacy Scale assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. GSES score is calculated by summing all item scores. The score ranges from 10-40 and higher scores indicating more self-efficacy. |
| Brief COPE - Adaptive Coping | Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention | The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. Reliance on adaptive coping strategies were calculated as the sum of the following subscales: active coping (item 2, 7), emotional support (item 5, 15), use of informational support (item 10, 23), positive reframing (item 12, 17), planning (item 14,25), acceptance (item 20, 24), religion (item 22, 27). Each of the subscales ranges from 2-8. The range of scores for adaptive coping is 14-56, with higher scores indicating higher adaptive coping. |
| Working Alliance Inventory - Bond | Intervention weeks 1-8 | Working alliance was measured on a weekly basis only in the intervention arm with the Working Alliance Inventory-SF. The survey has 12 items with subscales that measure affective bond, and agreement on tasks and goals and are scored using a Likert scale. The bond subscore was calculated by summing items 3, 5, 7, and 9. The subscale ranges from 4-28. A higher subscore indicates higher affective bond. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PEERS Peer mentors who have experience of depression are trained and supervised to deliver depression care. Peers will meet with depressed older adults for 8 weekly meeting lasting approximately 45 -60 minutes. Peer mentors will provide social support defined as emotional, informational and appraisal support that includes coping strategies. Peers will be supervised by a mental health professional.
PEERS: Peer mentors deliver depression care that include social support and coping skills, focused on goal setting and small behavioral changes. | 69 |
| Social Interaction A study staff member will provide eight weekly social interaction phone calls to the depressed older adult.
Social interaction: Study staff will provide a social interaction phone calls to the participants randomized to this condition. | 65 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-month | Lost to Follow-up | 11 | 8 |
| 3-month | Death | 1 | 0 |
| 3-month | Incomplete data collection | 9 | 7 |
| 3-month | Lost to Follow-up | 2 | 2 |
| 3-month | Withdrawal by Subject | 0 | 3 |
| 6-month | Incomplete data collection | 14 | 9 |
| 6-month | Lost to Follow-up | 1 | 1 |
| 6-month | Withdrawal by Subject | 0 | 3 |
| 9-month | Incomplete data collection | 8 | 5 |
| 9-month | Lost to Follow-up | 8 | 4 |
| 9-month | Withdrawal by Subject | 0 | 1 |
| Baseline | Lost to Follow-up | 4 | 5 |
| Baseline | Protocol Violation | 0 | 3 |
| Baseline | Withdrawal by Subject | 2 | 1 |
| Post-Intervention | Death | 0 | 1 |
| Post-Intervention | Incomplete Data Collection | 1 | 3 |
| Post-Intervention | Lost to Follow-up | 4 | 4 |
| Post-Intervention | Withdrawal by Subject | 8 | 5 |
Baseline characteristics
| Characteristic | PEERS | Social Interaction | Total |
|---|---|---|---|
| Age, Continuous | 69.0 Years | 70.0 Years | 69.5 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 65 Participants | 131 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Patient Health Questionnaire-9 | 10.81 units on a scale STANDARD_DEVIATION 4.88 | 10.4 units on a scale STANDARD_DEVIATION 4.7 | 10.6 units on a scale STANDARD_DEVIATION 4.78 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants | 35 Participants | 70 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 27 Participants | 28 Participants | 55 Participants |
| Region of Enrollment United States | 69 participants | 65 participants | 134 participants |
| Sex: Female, Male Female | 58 Participants | 55 Participants | 113 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 75 | 2 / 74 |
| other Total, other adverse events | 0 / 75 | 0 / 74 |
| serious Total, serious adverse events | 1 / 75 | 4 / 74 |
Outcome results
Primary
Patient Health Questionnaire-9
Depression will be assessed with the Patient Health Questionnaire (PHQ)-9. The PHQ-9 score is summed. There are 9 items in the questionnaire and scores range from 0 to 27. A score of 5 indicates mild depressive symptoms, 10 - 14 indicates moderate depression, 15-19 indicates moderately severe depression, 20-27 indicates severe depression.
Time frame: Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention
Population: All participants with at least one assessment completed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEERS | Patient Health Questionnaire-9 | Post-intervention | 6.66 score on a scale | Standard Deviation 4.51 |
| PEERS | Patient Health Questionnaire-9 | 6 Months | 7.95 score on a scale | Standard Deviation 4.81 |
| PEERS | Patient Health Questionnaire-9 | 12 Months | 8.09 score on a scale | Standard Deviation 5.05 |
| PEERS | Patient Health Questionnaire-9 | 9 Months | 8.77 score on a scale | Standard Deviation 5.57 |
| PEERS | Patient Health Questionnaire-9 | 3 Months | 7.89 score on a scale | Standard Deviation 4.91 |
| Social Interaction | Patient Health Questionnaire-9 | 9 Months | 7.14 score on a scale | Standard Deviation 4.57 |
| Social Interaction | Patient Health Questionnaire-9 | Post-intervention | 7.33 score on a scale | Standard Deviation 4.28 |
| Social Interaction | Patient Health Questionnaire-9 | 3 Months | 7.84 score on a scale | Standard Deviation 4.73 |
| Social Interaction | Patient Health Questionnaire-9 | 6 Months | 8.03 score on a scale | Standard Deviation 5.35 |
| Social Interaction | Patient Health Questionnaire-9 | 12 Months | 8.42 score on a scale | Standard Deviation 5.01 |
Comparison: Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to post-intervention for all study participants.p-value: <0.000195% CI: [-4.77, -2.62]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 3-month for all study participants.p-value: 0.000195% CI: [-3.81, -1.25]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 6-month for all study participants.p-value: <0.000195% CI: [-4.13, -1.53]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 9-month for all study participants.p-value: <0.000195% CI: [-4.03, -1.49]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 12-month for all study participants.p-value: 0.000395% CI: [-3.95, -1.17]Mixed Models Analysis
Comparison: Null hypothesis: There is no difference in the change of PHQ-9 over time between the control and PEERS participants.p-value: 0.4375Mixed Models Analysis
Secondary
Brief COPE - Adaptive Coping
The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. Reliance on adaptive coping strategies were calculated as the sum of the following subscales: active coping (item 2, 7), emotional support (item 5, 15), use of informational support (item 10, 23), positive reframing (item 12, 17), planning (item 14,25), acceptance (item 20, 24), religion (item 22, 27). Each of the subscales ranges from 2-8. The range of scores for adaptive coping is 14-56, with higher scores indicating higher adaptive coping.
Time frame: Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention
Population: All participants with at least one assessment completed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEERS | Brief COPE - Adaptive Coping | 3 Months | 44.5 score on a scale | Standard Deviation 7.86 |
| PEERS | Brief COPE - Adaptive Coping | 9 Months | 44.36 score on a scale | Standard Deviation 8.13 |
| PEERS | Brief COPE - Adaptive Coping | 6 Months | 42.7 score on a scale | Standard Deviation 7.44 |
| PEERS | Brief COPE - Adaptive Coping | 12 Months | 44.08 score on a scale | Standard Deviation 7.78 |
| PEERS | Brief COPE - Adaptive Coping | Post-intervention | 44.12 score on a scale | Standard Deviation 8.5 |
| Social Interaction | Brief COPE - Adaptive Coping | 12 Months | 39.57 score on a scale | Standard Deviation 9.22 |
| Social Interaction | Brief COPE - Adaptive Coping | Post-intervention | 41.31 score on a scale | Standard Deviation 7.43 |
| Social Interaction | Brief COPE - Adaptive Coping | 3 Months | 39.62 score on a scale | Standard Deviation 7.87 |
| Social Interaction | Brief COPE - Adaptive Coping | 6 Months | 41.22 score on a scale | Standard Deviation 6.99 |
| Social Interaction | Brief COPE - Adaptive Coping | 9 Months | 42.64 score on a scale | Standard Deviation 7.24 |
Comparison: Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to post-intervention for all study participants.p-value: <0.000195% CI: [1.71, 4.73]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 3-month for all study participants.p-value: 0.012395% CI: [0.57, 4.62]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 6-month for all study participants.p-value: 0.0195% CI: [0.63, 4.63]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 9-month for all study participants.p-value: <0.000195% CI: [2.32, 6.04]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 12-month for all study participants.p-value: 0.007895% CI: [0.83, 5.44]Mixed Models Analysis
Comparison: Null hypothesis: there is no statistical difference in the change in adaptive coping over time between control and PEERS participants.p-value: 0.1408Mixed Models Analysis
Secondary
Cornell Health Service Index - ER Service Use
Health service use is measured with the Cornell Service Index, a questionnaire that includes both clinical and informal community-based health services and has been used in depression care studies among older adults. The index asks whether an individual has used a list of services in the 4 months prior, what type of provider was seen, the site of the service, and reasons for service use. Numbers reported indicate the number of participants who reported hospital and emergency service use at specified timepoints.
Time frame: Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention
Population: All participants with at least one assessment completed
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PEERS | Cornell Health Service Index - ER Service Use | 9 Month | 13 Participants |
| PEERS | Cornell Health Service Index - ER Service Use | 3 Month | 12 Participants |
| PEERS | Cornell Health Service Index - ER Service Use | 6 Month | 7 Participants |
| PEERS | Cornell Health Service Index - ER Service Use | 12 Month | 4 Participants |
| PEERS | Cornell Health Service Index - ER Service Use | Post-intervention | 5 Participants |
| Social Interaction | Cornell Health Service Index - ER Service Use | 6 Month | 7 Participants |
| Social Interaction | Cornell Health Service Index - ER Service Use | 12 Month | 9 Participants |
| Social Interaction | Cornell Health Service Index - ER Service Use | 3 Month | 2 Participants |
| Social Interaction | Cornell Health Service Index - ER Service Use | Post-intervention | 8 Participants |
| Social Interaction | Cornell Health Service Index - ER Service Use | 9 Month | 9 Participants |
Comparison: Null hypothesis: there is no difference in the change in probability of ER use from baseline to post-intervention between PEERS and control participants.p-value: 0.031F-test for overall significance
Secondary
Engagement - Adherence
Engagement (adherence) was measured by percentage of attendance of meetings as reported by the peer mentors, with a threshold of 80% of meetings attended.
Time frame: Intervention 1-8 weeks
Population: All participants with at least one assessment completed
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PEERS | Engagement - Adherence | Week 1 | 67 Participants |
| PEERS | Engagement - Adherence | Week 2 | 64 Participants |
| PEERS | Engagement - Adherence | Week 3 | 61 Participants |
| PEERS | Engagement - Adherence | Week 4 | 61 Participants |
| PEERS | Engagement - Adherence | Week 5 | 60 Participants |
| PEERS | Engagement - Adherence | Week 6 | 59 Participants |
| PEERS | Engagement - Adherence | Week 7 | 57 Participants |
| PEERS | Engagement - Adherence | Week 8 | 57 Participants |
| Social Interaction | Engagement - Adherence | Week 8 | 56 Participants |
| Social Interaction | Engagement - Adherence | Week 1 | 62 Participants |
| Social Interaction | Engagement - Adherence | Week 5 | 58 Participants |
| Social Interaction | Engagement - Adherence | Week 2 | 61 Participants |
| Social Interaction | Engagement - Adherence | Week 7 | 56 Participants |
| Social Interaction | Engagement - Adherence | Week 3 | 60 Participants |
| Social Interaction | Engagement - Adherence | Week 6 | 56 Participants |
| Social Interaction | Engagement - Adherence | Week 4 | 59 Participants |
Secondary
General Self-Efficacy Scale
The General Self-Efficacy Scale assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. GSES score is calculated by summing all item scores. The score ranges from 10-40 and higher scores indicating more self-efficacy.
Time frame: Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention
Population: All participants with at least one assessment completed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEERS | General Self-Efficacy Scale | 3 Months | 27.93 score on a scale | Standard Deviation 5.21 |
| PEERS | General Self-Efficacy Scale | Post-intervention | 27.98 score on a scale | Standard Deviation 5.33 |
| PEERS | General Self-Efficacy Scale | 6 Months | 26.15 score on a scale | Standard Deviation 5.33 |
| PEERS | General Self-Efficacy Scale | 9 Months | 27.39 score on a scale | Standard Deviation 4.7 |
| PEERS | General Self-Efficacy Scale | 12 Months | 27.93 score on a scale | Standard Deviation 3.8 |
| Social Interaction | General Self-Efficacy Scale | Post-intervention | 27.92 score on a scale | Standard Deviation 4.59 |
| Social Interaction | General Self-Efficacy Scale | 9 Months | 28.65 score on a scale | Standard Deviation 4.28 |
| Social Interaction | General Self-Efficacy Scale | 3 Months | 26.62 score on a scale | Standard Deviation 3.91 |
| Social Interaction | General Self-Efficacy Scale | 12 Months | 28 score on a scale | Standard Deviation 4.93 |
| Social Interaction | General Self-Efficacy Scale | 6 Months | 27.91 score on a scale | Standard Deviation 4.06 |
Comparison: Null hypothesis: there is no difference in the mean GSES scores from baseline to post-intervention for all study participants.p-value: 0.00195% CI: [0.72, 2.86]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean GSES scores from baseline to 3-month for all study participants.p-value: 0.1895% CI: [-0.39, 2.25]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean GSES scores from baseline to 6-month for all study participants.p-value: 0.1195% CI: [-0.24, 2.45]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean GSES scores from baseline to 9-month for all study participants.p-value: 0.000695% CI: [0.98, 3.54]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean GSES scores from baseline to 12-month for all study participants.p-value: 0.00195% CI: [1.01, 3.95]Mixed Models Analysis
Comparison: Null hypothesis: There is no difference in the change of GSES scores over time between the control and PEERS participants.p-value: 0.1195Mixed Models Analysis
Secondary
Rand Health Survey Short Form 36 Item - Emotional Functioning
The RAND 36-Item Health Survey is a set of generic, coherent, and easily administered quality-of-life measures. Each item is scored on a 0 to 100 range. Higher scores indicate better functioning. The emotional functioning subscale was calculated using the average of 3 of the 36 items (item 17, 18, 19)
Time frame: Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention
Population: All participants with at least one assessment completed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEERS | Rand Health Survey Short Form 36 Item - Emotional Functioning | 9 month | 49.49 score on a scale | Standard Deviation 44.19 |
| PEERS | Rand Health Survey Short Form 36 Item - Emotional Functioning | 12 Month | 51.28 score on a scale | Standard Deviation 41.34 |
| PEERS | Rand Health Survey Short Form 36 Item - Emotional Functioning | Post-intervention | 44.44 score on a scale | Standard Deviation 42.95 |
| PEERS | Rand Health Survey Short Form 36 Item - Emotional Functioning | 3 Month | 49.21 score on a scale | Standard Deviation 41.8 |
| PEERS | Rand Health Survey Short Form 36 Item - Emotional Functioning | 6 Month | 48.96 score on a scale | Standard Deviation 43.16 |
| Social Interaction | Rand Health Survey Short Form 36 Item - Emotional Functioning | 6 Month | 57.58 score on a scale | Standard Deviation 40.2 |
| Social Interaction | Rand Health Survey Short Form 36 Item - Emotional Functioning | 9 month | 52.53 score on a scale | Standard Deviation 38.22 |
| Social Interaction | Rand Health Survey Short Form 36 Item - Emotional Functioning | 3 Month | 61.67 score on a scale | Standard Deviation 43.72 |
| Social Interaction | Rand Health Survey Short Form 36 Item - Emotional Functioning | 12 Month | 44.83 score on a scale | Standard Deviation 41.09 |
| Social Interaction | Rand Health Survey Short Form 36 Item - Emotional Functioning | Post-intervention | 52.94 score on a scale | Standard Deviation 44.81 |
Comparison: Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to post-intervention for all study participants.p-value: 0.012995% CI: [2.67, 22.37]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 3-month for all study participants.p-value: 0.000895% CI: [8.32, 31.36]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 6-month for all study participants.p-value: 0.003695% CI: [5.92, 30.06]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 9-month for all study participants.p-value: 0.00795% CI: [4.47, 28.01]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 12-month for all study participants.p-value: 0.06595% CI: [-0.68, 25.19]Mixed Models Analysis
Comparison: Null hypothesis: There is no difference in the change of emotional functioning over time between the control and PEERS participants.p-value: 0.881Mixed Models Analysis
Secondary
Rand Health Survey Short Form 36 Item - Social Functioning
The RAND 36-Item Health Survey is a set of generic, coherent, and easily administered quality-of-life measures. Each item is scored on a 0 to 100 range. Higher scores indicate better functioning. The social functioning subscale was calculated using the average of 2 of the 36 items (item 20, 32)
Time frame: Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention
Population: All participants with at least one assessment completed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEERS | Rand Health Survey Short Form 36 Item - Social Functioning | 3 Month | 64.29 score on a scale | Standard Deviation 32.26 |
| PEERS | Rand Health Survey Short Form 36 Item - Social Functioning | 9 Month | 38.75 score on a scale | Standard Deviation 28.58 |
| PEERS | Rand Health Survey Short Form 36 Item - Social Functioning | 6 Month | 59.47 score on a scale | Standard Deviation 25.59 |
| PEERS | Rand Health Survey Short Form 36 Item - Social Functioning | 12 Month | 5.73 score on a scale | Standard Deviation 61.54 |
| PEERS | Rand Health Survey Short Form 36 Item - Social Functioning | Post-intervention | 60.29 score on a scale | Standard Deviation 30.18 |
| Social Interaction | Rand Health Survey Short Form 36 Item - Social Functioning | 12 Month | 53.88 score on a scale | Standard Deviation 28.76 |
| Social Interaction | Rand Health Survey Short Form 36 Item - Social Functioning | Post-intervention | 59.56 score on a scale | Standard Deviation 25.32 |
| Social Interaction | Rand Health Survey Short Form 36 Item - Social Functioning | 3 Month | 66.88 score on a scale | Standard Deviation 26.18 |
| Social Interaction | Rand Health Survey Short Form 36 Item - Social Functioning | 6 Month | 63.71 score on a scale | Standard Deviation 28.75 |
| Social Interaction | Rand Health Survey Short Form 36 Item - Social Functioning | 9 Month | 60.61 score on a scale | Standard Deviation 32.79 |
Comparison: Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to post-intervention for all study participants.p-value: 0.1495% CI: [-1.63, 11.79]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 3-month for all study participants.p-value: 0.0195% CI: [2.45, 18.19]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 6-month for all study participants.p-value: 0.01595% CI: [2.01, 18.5]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 9-month for all study participants.p-value: 0.00495% CI: [3.7, 19.73]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 12-month for all study participants.p-value: 0.295% CI: [-3.09, 14.55]Mixed Models Analysis
Comparison: Null hypothesis: There is no difference in the change of social functioning over time between the control and PEERS participants.p-value: 0.8037Mixed Models Analysis
Secondary
Rand Health Survey Short Form 36 - Physical Functioning
The RAND 36-Item Health Survey is a set of generic, coherent, and easily administered quality-of-life measures. Each item is scored on a 0 to 100 range. Higher scores indicate better functioning.The physical functioning subscale was calculated using the average of 10 of the 36 items (item 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
Time frame: Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention
Population: All participants with at least one assessment completed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEERS | Rand Health Survey Short Form 36 - Physical Functioning | 3 Month | 50.12 score on a scale | Standard Deviation 29.02 |
| PEERS | Rand Health Survey Short Form 36 - Physical Functioning | 9 Month | 46.06 score on a scale | Standard Deviation 30.36 |
| PEERS | Rand Health Survey Short Form 36 - Physical Functioning | 6 Month | 43.48 score on a scale | Standard Deviation 27.34 |
| PEERS | Rand Health Survey Short Form 36 - Physical Functioning | 12 Month | 49.62 score on a scale | Standard Deviation 26.09 |
| PEERS | Rand Health Survey Short Form 36 - Physical Functioning | Post-Intervention | 47.64 score on a scale | Standard Deviation 28.82 |
| Social Interaction | Rand Health Survey Short Form 36 - Physical Functioning | 12 Month | 44.46 score on a scale | Standard Deviation 29.04 |
| Social Interaction | Rand Health Survey Short Form 36 - Physical Functioning | Post-Intervention | 50 score on a scale | Standard Deviation 30.07 |
| Social Interaction | Rand Health Survey Short Form 36 - Physical Functioning | 3 Month | 50.88 score on a scale | Standard Deviation 30.57 |
| Social Interaction | Rand Health Survey Short Form 36 - Physical Functioning | 6 Month | 49.69 score on a scale | Standard Deviation 29.13 |
| Social Interaction | Rand Health Survey Short Form 36 - Physical Functioning | 9 Month | 50.3 score on a scale | Standard Deviation 30.72 |
Comparison: Null hypothesis: there is no difference in the mean SF36 - Physical Functioning scores from baseline to post-intervention for all study participants.p-value: 0.5195% CI: [-3.15, 6.37]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 3-month for all study participants.p-value: 0.1895% CI: [-2.08, 11.21]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 6-month for all study participants.p-value: 0.6395% CI: [-4.89, 8.04]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 9-month for all study participants.p-value: 0.7495% CI: [-6.94, 4.91]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 12-month for all study participants.p-value: 0.8595% CI: [-6.82, 8.23]Mixed Models Analysis
Comparison: Null hypothesis: There is no difference in the change of physical functioning over time between the control and PEERS participants.p-value: 0.3988Mixed Models Analysis
Secondary
UCLA Loneliness Scale
The 20-item R-UCLA loneliness scale measures one's subjective feelings of loneliness as well as feelings of social isolation. Items are summed to create a score. The scores range from 20-80 and higher scores indicating higher level of loneliness. A total score of 20-34 represents low degree of loneliness; 35-49 represent moderate degree of loneliness; 50-64 represent moderately high degree of loneliness; and 65 or above represent high degree of loneliness.
Time frame: Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention
Population: All participants with at least one assessment completed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEERS | UCLA Loneliness Scale | Baseline | 51.54 score on a scale | Standard Deviation 15.75 |
| PEERS | UCLA Loneliness Scale | Post-intervention | 44.56 score on a scale | Standard Deviation 14.91 |
| PEERS | UCLA Loneliness Scale | 3 Months | 43.9 score on a scale | Standard Deviation 13.5 |
| PEERS | UCLA Loneliness Scale | 6 Months | 41.79 score on a scale | Standard Deviation 16.24 |
| PEERS | UCLA Loneliness Scale | 9 Months | 43.71 score on a scale | Standard Deviation 17.05 |
| PEERS | UCLA Loneliness Scale | 12 Months | 42.93 score on a scale | Standard Deviation 17.76 |
| Social Interaction | UCLA Loneliness Scale | 3 Months | 39.24 score on a scale | Standard Deviation 12.91 |
| Social Interaction | UCLA Loneliness Scale | Baseline | 47.67 score on a scale | Standard Deviation 15.43 |
| Social Interaction | UCLA Loneliness Scale | 9 Months | 39.94 score on a scale | Standard Deviation 14.12 |
| Social Interaction | UCLA Loneliness Scale | 12 Months | 40.17 score on a scale | Standard Deviation 14.56 |
| Social Interaction | UCLA Loneliness Scale | Post-intervention | 42.72 score on a scale | Standard Deviation 12.69 |
| Social Interaction | UCLA Loneliness Scale | 6 Months | 42.52 score on a scale | Standard Deviation 13.44 |
Comparison: Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to post-intervention for all study participants.p-value: 0.000595% CI: [-7.78, -2.18]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 3-month for all study participants.p-value: <0.000195% CI: [-11.08, -3.69]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 6-month for all study participants.p-value: <0.000195% CI: [-11.3, -3.95]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 9-month for all study participants.p-value: <0.000195% CI: [-11.53, -4.7]Mixed Models Analysis
Comparison: Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 12-month for all study participants.p-value: <0.000195% CI: [-12.37, -4.14]Mixed Models Analysis
Comparison: Null hypothesis: there is no statistical difference in the change of UCLA Loneliness score over time between control and PEERS participantsp-value: 0.6857Mixed Models Analysis
Secondary
Working Alliance Inventory - Bond
Working alliance was measured on a weekly basis only in the intervention arm with the Working Alliance Inventory-SF. The survey has 12 items with subscales that measure affective bond, and agreement on tasks and goals and are scored using a Likert scale. The bond subscore was calculated by summing items 3, 5, 7, and 9. The subscale ranges from 4-28. A higher subscore indicates higher affective bond.
Time frame: Intervention weeks 1-8
Population: All participants in the PEERS intervention with at least one assessment completed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEERS | Working Alliance Inventory - Bond | Week 1 | 23.28 score on a scale | Standard Deviation 5.14 |
| PEERS | Working Alliance Inventory - Bond | Week 2 | 24.49 score on a scale | Standard Deviation 3.38 |
| PEERS | Working Alliance Inventory - Bond | Week 3 | 24.63 score on a scale | Standard Deviation 3.31 |
| PEERS | Working Alliance Inventory - Bond | Week 4 | 25.02 score on a scale | Standard Deviation 2.95 |
| PEERS | Working Alliance Inventory - Bond | Week 5 | 25.02 score on a scale | Standard Deviation 3.38 |
| PEERS | Working Alliance Inventory - Bond | Week 6 | 25.45 score on a scale | Standard Deviation 3.02 |
| PEERS | Working Alliance Inventory - Bond | Week 7 | 25.51 score on a scale | Standard Deviation 2.86 |
| PEERS | Working Alliance Inventory - Bond | Week 8 | 26.17 score on a scale | Standard Deviation 2.53 |
Secondary
Working Alliance Inventory - Goal
Working alliance was measured on a weekly basis only in the intervention arm with the Working Alliance Inventory-SF. The survey has 12 items with subscales that measure affective bond, and agreement on tasks and goals and are scored using a Likert scale. The goal subscore was calculated by summing items 1, 6, 8, and 11. The subscale ranges from scores of 4-28, with higher scores indicating better agreement on goals.
Time frame: Intervention weeks 1-8
Population: All participants in the PEERS intervention with at least one assessment completed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEERS | Working Alliance Inventory - Goal | Week 8 | 26.21 score on a scale | Standard Deviation 2.33 |
| PEERS | Working Alliance Inventory - Goal | Week 1 | 21.85 score on a scale | Standard Deviation 5.28 |
| PEERS | Working Alliance Inventory - Goal | Week 2 | 23.17 score on a scale | Standard Deviation 3.83 |
| PEERS | Working Alliance Inventory - Goal | Week 3 | 23.98 score on a scale | Standard Deviation 3.81 |
| PEERS | Working Alliance Inventory - Goal | Week 4 | 25.05 score on a scale | Standard Deviation 2.95 |
| PEERS | Working Alliance Inventory - Goal | Week 5 | 24.85 score on a scale | Standard Deviation 3.23 |
| PEERS | Working Alliance Inventory - Goal | Week 6 | 25.1 score on a scale | Standard Deviation 3.22 |
| PEERS | Working Alliance Inventory - Goal | Week 7 | 25.63 score on a scale | Standard Deviation 3 |
Secondary
Working Alliance Inventory - Task
Working alliance was measured on a weekly basis only in the intervention arm with the Working Alliance Inventory-SF. The survey has 12 items with subscales that measure affective bond, and agreement on tasks and goals and are scored using a Likert scale. The task subscore was calculated by summing items 2, 4, 10, and 12. The subscale ranges from 4-28. A higher subscore indicates higher agreement on tasks.
Time frame: Intervention weeks 1-8
Population: All participants in the PEERS intervention with at least one assessment completed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEERS | Working Alliance Inventory - Task | Week 3 | 22.67 score on a scale | Standard Deviation 4.12 |
| PEERS | Working Alliance Inventory - Task | Week 4 | 23.13 score on a scale | Standard Deviation 4.32 |
| PEERS | Working Alliance Inventory - Task | Week 5 | 23.03 score on a scale | Standard Deviation 4.25 |
| PEERS | Working Alliance Inventory - Task | Week 8 | 24.69 score on a scale | Standard Deviation 3.62 |
| PEERS | Working Alliance Inventory - Task | Week 1 | 21.24 score on a scale | Standard Deviation 4.39 |
| PEERS | Working Alliance Inventory - Task | Week 2 | 20.97 score on a scale | Standard Deviation 4.15 |
| PEERS | Working Alliance Inventory - Task | Week 6 | 23.31 score on a scale | Standard Deviation 4.11 |
| PEERS | Working Alliance Inventory - Task | Week 7 | 24.12 score on a scale | Standard Deviation 3.82 |