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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH123165 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEERS | Experimental | 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 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. |
|
| Social interaction | Active Comparator | A study staff member will provide eight weekly social interaction visits and phone calls to the depressed older adult. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEERS | Behavioral | Peer mentors deliver depression care that include social support and coping skills, focused on goal setting and small behavioral changes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39438236 | Derived | Joo JH, Xie A, Choi N, Gallo JJ, Zhong Y, Ma M, Locascio JJ, Khemraj U, Mace RA, Solomon P. A Mixed Methods Effectiveness Study of a Peer Support Intervention for Older Adults During the COVID-19 Pandemic: Results of a Randomized Clinical Trial. Am J Geriatr Psychiatry. 2025 Apr;33(4):389-401. doi: 10.1016/j.jagp.2024.09.013. Epub 2024 Oct 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| 12-month |
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Baseline analysis population consists of participants randomized to one of the study arm and completed baseline assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants with at least one assessment completed | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention |
|
Adverse event data is collected through study completion, an average of 18 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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Drop outs leading to small number of subjects analyzed at 12 month follow up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jin hui Joo | Mass General Hospital | 410-724-5317 | jhjoo@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2020 | Jun 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004347 | Drug Interactions |
| ID | Term |
|---|---|
| D000069437 | Pharmacological Phenomena |
| D002620 | Pharmacological and Toxicological Phenomena |
| D010829 | Physiological Phenomena |
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| Social interaction | Other | Study staff will provide a combination of 8 social interaction visits and phone calls to the participants randomized to this condition. |
|
| 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) | Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention |
| 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) | Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention |
| 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. | Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention |
| 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. | Intervention 1-8 weeks |
| 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. | Intervention weeks 1-8 |
| 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. | Intervention weeks 1-8 |
| 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. | Intervention weeks 1-8 |
| 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. | Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention |
| 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. | Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention |
| 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. | Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
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| NOT COMPLETED |
|
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| NOT COMPLETED |
|
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| NOT COMPLETED |
|
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| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Social Interaction | A study staff member will provide eight weekly social interaction visits and phone calls to the depressed older adult. Social interaction: Study staff will provide a combination of 8 social interaction visits and phone calls to the participants randomized to this condition. |
|
|
|
| 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) | All participants with at least one assessment completed | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention |
|
|
|
|
| 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) | All participants with at least one assessment completed | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention |
|
|
|
|
| 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) | All participants with at least one assessment completed | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention (8-week), 3 months after intervention , 6 months after intervention, 9 months after intervention, 12 months intervention |
|
|
|
|
| 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. | All participants with at least one assessment completed | Posted | Count of Participants | Participants | Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention |
|
|
|
|
| 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. | All participants with at least one assessment completed | Posted | Count of Participants | Participants | Intervention 1-8 weeks |
|
|
|
| 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. | All participants in the PEERS intervention with at least one assessment completed | Posted | Mean | Standard Deviation | score on a scale | Intervention weeks 1-8 |
|
|
|
| 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. | All participants in the PEERS intervention with at least one assessment completed | Posted | Mean | Standard Deviation | score on a scale | Intervention weeks 1-8 |
|
|
|
| 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. | All participants in the PEERS intervention with at least one assessment completed | Posted | Mean | Standard Deviation | score on a scale | Intervention weeks 1-8 |
|
|
|
| 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. | All participants with at least one assessment completed | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention |
|
|
|
|
| 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. | All participants with at least one assessment completed | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention |
|
|
|
|
| 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. | All participants with at least one assessment completed | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention (8-week), 3 months after intervention, 6 months after intervention, 9 months after intervention, 12 months after intervention |
|
|
|
|
| 1 |
| 75 |
| 1 |
| 75 |
| 0 |
| 75 |
| EG001 | 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. | 2 | 74 | 4 | 74 | 0 | 74 |
| Death | General disorders | Non-systematic Assessment |
|
| Admission to Hospice | General disorders | Non-systematic Assessment |
|
| Death | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Death | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
Not provided
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| 3 Month |
|
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| 6 Month |
|
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| 9 Month |
|
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| 12 Month |
|
|
A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.
| Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 3-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 364 | 0.18 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 4.57 | 2-Sided | 95 | -2.08 | 11.21 | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 6-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 364 | 0.63 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 1.57 | Standard Error of the Mean | 3.29 | 2-Sided | 95 | -4.89 | 8.04 | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 9-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 364 | 0.74 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | -1.02 | Standard Error of the Mean | 3.01 | 2-Sided | 95 | -6.94 | 4.91 | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 12-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 364 | 0.85 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 0.7 | Standard Error of the Mean | 3.83 | 2-Sided | 95 | -6.82 | 8.23 | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: There is no difference in the change of physical functioning over time between the control and PEERS participants. | Mixed Models Analysis | 0.3988 | Superiority |
| 3 Month |
|
|
| 6 Month |
|
|
| 9 Month |
|
|
| 12 Month |
|
|
A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.
| Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 3-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 360 | 0.01 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 10.32 | Standard Error of the Mean | 4 | 2-Sided | 95 | 2.45 | 18.19 | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 6-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 360 | 0.015 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 10.25 | Standard Error of the Mean | 4.19 | 2-Sided | 95 | 2.01 | 18.5 | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 9-month for all study participants. | Mixed Models Analysis | degrees of freedom: 360 | 0.004 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 11.72 | Standard Error of the Mean | 4.07 | 2-Sided | 95 | 3.7 | 19.73 | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 12-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 360 | 0.2 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 5.73 | Standard Error of the Mean | 4.49 | 2-Sided | 95 | -3.09 | 14.55 | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: There is no difference in the change of social functioning over time between the control and PEERS participants. | Mixed Models Analysis | 0.8037 | Superiority |
| 3 Month |
|
|
| 6 Month |
|
|
| 9 month |
|
|
| 12 Month |
|
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A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.
| Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 3-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 366 | 0.0008 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 19.84 | Standard Error of the Mean | 5.86 | 2-Sided | 95 | 8.32 | 31.36 | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 6-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 366 | 0.0036 | The a priori threshold for statistical significance is p=0.05. | Median Difference (Net) | 17.99 | Standard Error of the Mean | 6.14 | 2-Sided | 95 | 5.92 | 30.06 | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 9-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 366 | 0.007 | The a priori threshold for statistical significance is p=0.05. | Median Difference (Net) | 16.24 | Standard Error of the Mean | 5.98 | 2-Sided | 95 | 4.47 | 28.01 | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 12-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 366 | 0.065 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 12.26 | Standard Error of the Mean | 6.58 | 2-Sided | 95 | -0.68 | 25.19 | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: There is no difference in the change of emotional functioning over time between the control and PEERS participants. | Mixed Models Analysis | 0.8810 | Superiority |
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A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 3-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 414 | <0.0001 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | -7.38 | Standard Error of the Mean | 1.88 | 2-Sided | 95 | -11.08 | -3.69 | Score difference: 3-month - baseline | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 6-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 414 | <0.0001 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | -7.63 | Standard Error of the Mean | 1.87 | 2-Sided | 95 | -11.3 | -3.95 | Score difference: 6-month - baseline | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 9-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 414 | <0.0001 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | -8.12 | Standard Error of the Mean | 1.74 | 2-Sided | 95 | -11.53 | -4.7 | Score difference: 9-month - baseline | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 12-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 414 | <0.0001 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | -8.26 | Standard Error of the Mean | 2.09 | 2-Sided | 95 | -12.37 | -4.14 | Score difference: 12-month - baseline | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no statistical difference in the change of UCLA Loneliness score over time between control and PEERS participants | Mixed Models Analysis | 0.6857 | Superiority |
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| Null hypothesis: there is no difference in the mean GSES scores from baseline to 3-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 421 | 0.18 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 0.93 | Standard Error of the Mean | 0.67 | 2-Sided | 95 | -0.39 | 2.25 | Score difference: 3-month - baseline | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean GSES scores from baseline to 6-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 421 | 0.11 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 1.11 | Standard Error of the Mean | 0.68 | 2-Sided | 95 | -0.24 | 2.45 | Score difference: 6-month - baseline | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean GSES scores from baseline to 9-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 421 | 0.0006 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 2.26 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | 0.98 | 3.54 | Score difference: 9-month - baseline | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean GSES scores from baseline to 12-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 421 | 0.001 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 2.48 | Standard Error of the Mean | 0.75 | 2-Sided | 95 | 1.01 | 3.95 | Score difference: 12-month - baseline | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: There is no difference in the change of GSES scores over time between the control and PEERS participants. | Mixed Models Analysis | 0.1195 | Superiority |
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A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 3-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 361 | 0.0123 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 2.59 | Standard Error of the Mean | 1.03 | 2-Sided | 95 | 0.57 | 4.62 | Score difference: 3-month - baseline | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 6-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 361 | 0.01 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 2.63 | Standard Error of the Mean | 1.02 | 2-Sided | 95 | 0.63 | 4.63 | Score difference: 6-month - baseline | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 9-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 361 | <0.0001 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 4.18 | Standard Error of the Mean | 0.95 | 2-Sided | 95 | 2.32 | 6.04 | Score difference: 9-month - baseline | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 12-month for all study participants. | Mixed Models Analysis | Degrees of freedom: 361 | 0.0078 | The a priori threshold for statistical significance is p=0.05. | Mean Difference (Net) | 3.14 | Standard Error of the Mean | 1.17 | 2-Sided | 95 | 0.83 | 5.44 | Score difference: 12-month - baseline | Superiority | A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group * time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant. |
| Null hypothesis: there is no statistical difference in the change in adaptive coping over time between control and PEERS participants. | Mixed Models Analysis | 0.1408 | Superiority |