Anxiety
Conditions
Keywords
anxiety, worry
Brief summary
The purpose of this research study is to see how helpful two different interventions offered through the Calmer Life program are in reducing worry and improving mood. The investigators also want to understand how a program like Calmer Life can be offered in underserved communities.
Detailed description
Background: Recurrent, excessive, uncontrollable worry about multiple topics is common in older adults, but it is not well studied. This significant worry can negatively affect thinking, and it is associated with poorer sleep, more depression, and worse general health. Despite its prevalence, researchers have not studied significant worry enough, particularly in low-income racial and ethnic minority populations. We know these groups are unlikely to have adequate mental health care. We also know that older adults and minorities prefer treatments for worry that do not require medication, and that these kinds of treatments can be effective. Additional tests of treatments that do not involve drugs are needed in low-income racial and ethnic minority populations. Such person-centered research could expand access to appropriate care. Objectives: The study team plans to compare two approaches, one called Calmer Life (CL) and another called Enhanced Community Care (ECC). CL helps individuals by providing worry-reduction skills and resource counseling for basic needs in a flexible, culturally supportive manner. ECC relies on standard information and resource counseling. The study will answer three questions. First, compared to ECC, is CL more effective at relieving significant worry? Second, which one is more effective at reducing anxiety and depression and improving sleep, ability to do daily activities, and use of medical services? Third, are improvements still present three months after treatment concludes? Methods: In agreement with our community partners and governed by a council of community leaders, consumers, and providers from low-income minority communities, we will conduct the study. This community-academic partnership, created four years ago, introduced CL to the community. Case managers and community health workers from partner organizations were trained to implement CL. They taught worry-reduction skills and helped participants increase their use of community resources. Content was flexible so that participants could choose which skills to learn and whether or not to include religion or spirituality. They also could learn skills at home, by telephone, or in the community. In a new, larger comparison study, we will enroll 120 women and 30 men who are 50 years of age or older with significant worry. Most (80 percent) will be African American, and 70 percent will have income below poverty. Participants will be assigned by chance to CL or ECC and treated for six months. Brief assessments at enrollment and at six and nine months will rely on participants' reports. Differences will be measured statistically.
Interventions
BEHAVIORALCognitive behavior treatment
Anxiety management skills with the option to included religious/spiritual beliefs and practices
BEHAVIORALInformation and referral
Resource counseling and follow-up for mental health and basic needs
Sponsors
Patient-Centered Outcomes Research Institute
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PSWQ greater than 22
Exclusion criteria
* PHQ score less than 20 * Active suicidal intent * Active psychosis or bipolar disorder * Substance abuse * Cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months | Baseline, 6 months | Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety. |
| Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months | Baseline, 9 months | Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety. |
| Generalized Anxiety Disorder-7 (GAD-7) at 6 Months | Baseline, 6 months | Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms. |
| Generalized Anxiety Disorder-7 (GAD-7) at 9 Months | Baseline, 9 months | Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months | Baseline, 6 months | Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity. |
| Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months | Baseline, 9 months | Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity. |
| Insomnia Severity Index (ISI) at 9 Months | Baseline, 9 months | Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties. |
| Geriatric Depression Scale Short Form (GDS) at 6 Months | Baseline, 6 months | Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression. |
| Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months | Baseline, 6 months | Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning. |
| Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months | Baseline, 9 months | Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning. |
| Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months | Baseline, 6 months | Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning. |
| Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation | Baseline, 9 months | Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning. |
| Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months | Baseline, 6 months | Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning. |
| Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) | Baseline, 9 months | Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning. |
| Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months | Baseline, 6 months | Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning. |
| Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months | Baseline, 6 months | Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety. |
| PTSD Checklist-5 (PCL-5) Total at 6 Months | Baseline, 6 months | Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity. |
| PTSD Checklist-5 (PCL-5) Total at 9 Months | Baseline, 9 months | Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity. |
| Health Service Use at 6 Months | Baseline, 6 months | Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months. |
| Health Service Use at 9 Months | Baseline, 9 months | Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months. |
| Hospital Admissions at 6 Months | Baseline, 6 months | Number of participants who were admitted to a hospital in the past 3 months. |
| Hospital Admissions at 9 Months | Baseline, 9 months | Number of participants who were admitted to a hospital in the past 3 months. |
| Social Service or Resource Use at 6 Months | Baseline, 6 months | Number of participants who received social services or resources over the past 3 months |
| Social Service or Resource Use at 9 Months | Baseline, 9 months | Number of participants who received social services or resources over the past 3 months |
| Psychological Service Use at 6 Months | Baseline, 6 months | Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months |
| Psychological Service Use at 9 Months | Baseline, 9 months | Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months |
| Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months | Baseline, 9 months | Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning. |
| Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months | Baseline, 9 months | Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety. |
| Geriatric Depression Scale Short Form (GDS) at 9 Months | Baseline, 9 months | Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression. |
| Insomnia Severity Index (ISI) at 6 Months | Baseline, 6 months | Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred from February 2015 through October 2016 in community settings where older adults gather and/or receive services such as social service agencies, churches, senior housing and community centers.
Pre-assignment details
Prior to random assignment, participants were screened at three separate times. During this process, 84 participants were ineligible due to presence of exclusionary criteria, 24 were lost to follow-up and 5 withdrew from the study.
Participants by arm
| Arm | Count |
|---|---|
| Calmer Life Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices | 70 |
| Enhanced Community Care Enhanced information and referral services for mental health and basic needs
Information and referral: Resource counseling and follow-up for mental health and basic needs | 64 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 5 |
| Overall Study | Withdrawal by Subject | 6 | 3 |
Baseline characteristics
| Characteristic | Calmer Life | Enhanced Community Care | Total |
|---|---|---|---|
| Age, Continuous | 66.69 years STANDARD_DEVIATION 9.394 | 67.14 years STANDARD_DEVIATION 9.127 | 66.90 years STANDARD_DEVIATION 9.235 |
| Brief RCOPE Negative subscale | 10.38 units on a scale STANDARD_DEVIATION 4.815 | 10.96 units on a scale STANDARD_DEVIATION 5.044 | 10.66 units on a scale STANDARD_DEVIATION 4.915 |
| Brief RCOPE Positive Subscale | 24.22 units on a scale STANDARD_DEVIATION 4.702 | 23.84 units on a scale STANDARD_DEVIATION 4.144 | 24.04 units on a scale STANDARD_DEVIATION 4.424 |
| Diagnoses Any Depressive Disorder | 35 Participants | 34 Participants | 69 Participants |
| Diagnoses Generalized Anxiety Disorder (GAD) | 57 Participants | 45 Participants | 102 Participants |
| Diagnoses None recorded | 5 Participants | 4 Participants | 9 Participants |
| Diagnoses OSAD (Other) | 3 Participants | 3 Participants | 6 Participants |
| Diagnoses Other Specificied Anxiety Disorder (OSAD) (GAD) | 4 Participants | 10 Participants | 14 Participants |
| Diagnoses Panic | 4 Participants | 2 Participants | 6 Participants |
| Diagnoses Post Traumatic Stress Dissorder (PTSD) | 5 Participants | 3 Participants | 8 Participants |
| Diagnoses Social Phobia | 13 Participants | 19 Participants | 32 Participants |
| Diagnoses Specific Phobia | 26 Participants | 33 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants | 61 Participants | 128 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Expectancy Rating Scale (ERS) Cred | 26.34 units on a scale STANDARD_DEVIATION 4.213 | 25.03 units on a scale STANDARD_DEVIATION 5.688 | 25.72 units on a scale STANDARD_DEVIATION 4.991 |
| Expectancy Rating Scale (ERS) Exp | 8.58 units on a scale STANDARD_DEVIATION 1.762 | 7.69 units on a scale STANDARD_DEVIATION 2.65 | 8.16 units on a scale STANDARD_DEVIATION 2.264 |
| Generalized Anxiety Disorder-7 (GAD-7) | 11.00 units on a scale STANDARD_DEVIATION 5.421 | 10.56 units on a scale STANDARD_DEVIATION 5.108 | 10.79 units on a scale STANDARD_DEVIATION 5.259 |
| Geriatric Anxiety Inventory-SF (GAI-SF) | 3.39 units on a scale STANDARD_DEVIATION 1.544 | 3.30 units on a scale STANDARD_DEVIATION 1.752 | 3.34 units on a scale STANDARD_DEVIATION 1.641 |
| Geriatric Depression Scale Short Form (GDS) | 5.97 units on a scale STANDARD_DEVIATION 3.547 | 5.61 units on a scale STANDARD_DEVIATION 3.697 | 5.80 units on a scale STANDARD_DEVIATION 3.61 |
| Income <$10,000 | 13 Participants | 23 Participants | 36 Participants |
| Income $10,000 - $20,000 | 29 Participants | 24 Participants | 53 Participants |
| Income $20,000 - $30,000 | 11 Participants | 8 Participants | 19 Participants |
| Income $30,000 - $40,000 | 8 Participants | 4 Participants | 12 Participants |
| Income $40,000 - $50,000 | 3 Participants | 3 Participants | 6 Participants |
| Income $50,000 - $60,000 | 5 Participants | 1 Participants | 6 Participants |
| Income ≥$60,000 | 1 Participants | 1 Participants | 2 Participants |
| Insomnia Severity Index (ISI) | 13.44 units on a scale STANDARD_DEVIATION 6.841 | 13.00 units on a scale STANDARD_DEVIATION 6.264 | 13.23 units on a scale STANDARD_DEVIATION 6.551 |
| Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency | 48.90 units on a scale STANDARD_DEVIATION 6.281 | 48.05 units on a scale STANDARD_DEVIATION 7.231 | 48.49 units on a scale STANDARD_DEVIATION 6.739 |
| Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation | 59.05 units on a scale STANDARD_DEVIATION 10.799 | 59.38 units on a scale STANDARD_DEVIATION 10.429 | 59.21 units on a scale STANDARD_DEVIATION 10.585 |
| Marital Status Divorced | 29 Participants | 20 Participants | 49 Participants |
| Marital Status Married | 18 Participants | 15 Participants | 33 Participants |
| Marital Status Never Married | 7 Participants | 11 Participants | 18 Participants |
| Marital Status Separated | 3 Participants | 2 Participants | 5 Participants |
| Marital Status Widowed | 13 Participants | 16 Participants | 29 Participants |
| Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) | 38.38 units on a scale STANDARD_DEVIATION 12.468 | 38.51 units on a scale STANDARD_DEVIATION 11.498 | 38.44 units on a scale STANDARD_DEVIATION 11.969 |
| Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) | 40.08 units on a scale STANDARD_DEVIATION 9.708 | 40.14 units on a scale STANDARD_DEVIATION 10.15 | 40.11 units on a scale STANDARD_DEVIATION 9.884 |
| Medication Use, Total Non-psychotropic | 4.64 number of medications STANDARD_DEVIATION 3.323 | 4.51 number of medications STANDARD_DEVIATION 3.671 | 4.58 number of medications STANDARD_DEVIATION 3.48 |
| Medication Use, Total Psychotropic | 0.50 number of medications STANDARD_DEVIATION 0.897 | 0.44 number of medications STANDARD_DEVIATION 0.778 | 0.47 number of medications STANDARD_DEVIATION 0.84 |
| Patient Health Questionnaire depression scale (PHQ 8) | 11.41 units on a scale STANDARD_DEVIATION 6.076 | 11.13 units on a scale STANDARD_DEVIATION 5.849 | 11.28 units on a scale STANDARD_DEVIATION 5.948 |
| Penn State Worry Questionnaire-A (PSWQ-A) | 26.73 units on a scale STANDARD_DEVIATION 7.535 | 26.25 units on a scale STANDARD_DEVIATION 6.933 | 26.50 units on a scale STANDARD_DEVIATION 7.231 |
| Psychotropic Medication Use Anti-anxiety | 7 Participants | 7 Participants | 14 Participants |
| Psychotropic Medication Use Anti-depressant | 16 Participants | 13 Participants | 29 Participants |
| Psychotropic Medication Use Anti-psychotic | 4 Participants | 1 Participants | 5 Participants |
| Psychotropic Medication Use Any psychotropic | 21 Participants | 18 Participants | 39 Participants |
| Psychotropic Medication Use Hypnotic/Sleep | 7 Participants | 7 Participants | 14 Participants |
| PTSD Checklist-5 (PCL-5) Total | 28.77 units on a scale STANDARD_DEVIATION 16.601 | 26.92 units on a scale STANDARD_DEVIATION 16.157 | 27.89 units on a scale STANDARD_DEVIATION 16.355 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants | 54 Participants | 103 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 18 Participants | 10 Participants | 28 Participants |
| Region of Enrollment United States | 70 Participants | 64 Participants | 134 Participants |
| Service Use Health Services | 64 Participants | 56 Participants | 120 Participants |
| Service Use Hospital Admissions | 12 Participants | 10 Participants | 22 Participants |
| Service Use Psychological Services | 42 Participants | 29 Participants | 71 Participants |
| Service Use Social Services | 22 Participants | 17 Participants | 39 Participants |
| Sex: Female, Male Female | 61 Participants | 48 Participants | 109 Participants |
| Sex: Female, Male Male | 9 Participants | 16 Participants | 25 Participants |
| Years of Education | 13.91 years STANDARD_DEVIATION 2.853 | 13.28 years STANDARD_DEVIATION 2.74 | 13.61 years STANDARD_DEVIATION 2.807 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 64 |
| other Total, other adverse events | 0 / 70 | 0 / 64 |
| serious Total, serious adverse events | 0 / 70 | 0 / 64 |
Outcome results
Primary
Generalized Anxiety Disorder-7 (GAD-7) at 6 Months
Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms.
Time frame: Baseline, 6 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Generalized Anxiety Disorder-7 (GAD-7) at 6 Months | Baseline | 11.00 units on a scale | Standard Deviation 5.42 |
| Calmer Life | Generalized Anxiety Disorder-7 (GAD-7) at 6 Months | 6 months | 7.13 units on a scale | Standard Deviation 6.41 |
| Enhanced Community Care | Generalized Anxiety Disorder-7 (GAD-7) at 6 Months | Baseline | 10.56 units on a scale | Standard Deviation 5.11 |
| Enhanced Community Care | Generalized Anxiety Disorder-7 (GAD-7) at 6 Months | 6 months | 8.11 units on a scale | Standard Deviation 5.69 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GAD-7, controlling for baseline GAD-7.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.34ANCOVA
Primary
Generalized Anxiety Disorder-7 (GAD-7) at 9 Months
Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms.
Time frame: Baseline, 9 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Generalized Anxiety Disorder-7 (GAD-7) at 9 Months | Baseline | 11.00 units on a scale | Standard Deviation 5.42 |
| Calmer Life | Generalized Anxiety Disorder-7 (GAD-7) at 9 Months | 9 months | 7.54 units on a scale | Standard Deviation 5.51 |
| Enhanced Community Care | Generalized Anxiety Disorder-7 (GAD-7) at 9 Months | Baseline | 10.56 units on a scale | Standard Deviation 5.11 |
| Enhanced Community Care | Generalized Anxiety Disorder-7 (GAD-7) at 9 Months | 9 months | 6.62 units on a scale | Standard Deviation 5.66 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GAD-7, controlling for baseline GAD-7.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.08ANCOVA
Primary
Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months
Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety.
Time frame: Baseline, 6 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months | Baseline | 26.73 units on a scale | Standard Deviation 7.53 |
| Calmer Life | Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months | 6 months | 22.04 units on a scale | Standard Deviation 8.54 |
| Enhanced Community Care | Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months | Baseline | 26.25 units on a scale | Standard Deviation 6.93 |
| Enhanced Community Care | Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months | 6 months | 23.04 units on a scale | Standard Deviation 7.17 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PSWQ-A, controlling for baseline PSWQ-A.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate of .05.p-value: 0.77ANCOVA
Primary
Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months
Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety.
Time frame: Baseline, 9 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months | Baseline | 26.73 units on a scale | Standard Deviation 7.53 |
| Calmer Life | Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months | 9 months | 21.87 units on a scale | Standard Deviation 8.72 |
| Enhanced Community Care | Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months | Baseline | 26.25 units on a scale | Standard Deviation 6.93 |
| Enhanced Community Care | Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months | 9 months | 20.18 units on a scale | Standard Deviation 7.7 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PSWQ-A, controlling for baseline PSWQ-A.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.07ANCOVA
Secondary
Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months
Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety.
Time frame: Baseline, 6 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months | Baseline | 3.39 units on a scale | Standard Deviation 1.54 |
| Calmer Life | Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months | 6 months | 2.25 units on a scale | Standard Deviation 2 |
| Enhanced Community Care | Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months | Baseline | 3.30 units on a scale | Standard Deviation 1.75 |
| Enhanced Community Care | Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months | 6 months | 2.48 units on a scale | Standard Deviation 1.78 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GAI-SF, controlling for baseline GAI-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.45ANCOVA
Secondary
Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months
Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety.
Time frame: Baseline, 9 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months | Baseline | 3.39 units on a scale | Standard Deviation 1.54 |
| Calmer Life | Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months | 9 months | 2.65 units on a scale | Standard Deviation 2.11 |
| Enhanced Community Care | Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months | Baseline | 3.30 units on a scale | Standard Deviation 1.75 |
| Enhanced Community Care | Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months | 9 months | 2.31 units on a scale | Standard Deviation 1.71 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GAI-SF, controlling for baseline GAI-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.13ANCOVA
Secondary
Geriatric Depression Scale Short Form (GDS) at 6 Months
Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression.
Time frame: Baseline, 6 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Geriatric Depression Scale Short Form (GDS) at 6 Months | Baseline | 5.97 units on a scale | Standard Deviation 3.55 |
| Calmer Life | Geriatric Depression Scale Short Form (GDS) at 6 Months | 6 months | 3.75 units on a scale | Standard Deviation 3.42 |
| Enhanced Community Care | Geriatric Depression Scale Short Form (GDS) at 6 Months | Baseline | 5.61 units on a scale | Standard Deviation 3.7 |
| Enhanced Community Care | Geriatric Depression Scale Short Form (GDS) at 6 Months | 6 months | 4.33 units on a scale | Standard Deviation 3.44 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GDS-SF, controlling for baseline GDS-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.14ANCOVA
Secondary
Geriatric Depression Scale Short Form (GDS) at 9 Months
Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression.
Time frame: Baseline, 9 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Geriatric Depression Scale Short Form (GDS) at 9 Months | Baseline | 5.97 units on a scale | Standard Deviation 3.55 |
| Calmer Life | Geriatric Depression Scale Short Form (GDS) at 9 Months | 9 months | 3.80 units on a scale | Standard Deviation 3.49 |
| Enhanced Community Care | Geriatric Depression Scale Short Form (GDS) at 9 Months | Baseline | 5.61 units on a scale | Standard Deviation 3.7 |
| Enhanced Community Care | Geriatric Depression Scale Short Form (GDS) at 9 Months | 9 months | 3.92 units on a scale | Standard Deviation 3.19 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GDS-SF, controlling for baseline GDS-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.59ANCOVA
Secondary
Health Service Use at 6 Months
Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months.
Time frame: Baseline, 6 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Calmer Life | Health Service Use at 6 Months | Baseline | 64 Participants |
| Calmer Life | Health Service Use at 6 Months | 6 months | 47 Participants |
| Enhanced Community Care | Health Service Use at 6 Months | Baseline | 56 Participants |
| Enhanced Community Care | Health Service Use at 6 Months | 6 months | 45 Participants |
p-value: 0.52Regression, Logistic
Secondary
Health Service Use at 9 Months
Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months.
Time frame: Baseline, 9 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Calmer Life | Health Service Use at 9 Months | 9 months | 52 Participants |
| Calmer Life | Health Service Use at 9 Months | Baseline | 64 Participants |
| Enhanced Community Care | Health Service Use at 9 Months | Baseline | 56 Participants |
| Enhanced Community Care | Health Service Use at 9 Months | 9 months | 39 Participants |
Comparison: We expected to reject the null hypothesis of no treatment group difference in 9 month health service use, controlling for baseline health service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.04Regression, Logistic
Secondary
Hospital Admissions at 6 Months
Number of participants who were admitted to a hospital in the past 3 months.
Time frame: Baseline, 6 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Calmer Life | Hospital Admissions at 6 Months | Baseline | 12 Participants |
| Calmer Life | Hospital Admissions at 6 Months | 6 months | 12 Participants |
| Enhanced Community Care | Hospital Admissions at 6 Months | Baseline | 10 Participants |
| Enhanced Community Care | Hospital Admissions at 6 Months | 6 months | 5 Participants |
Comparison: We expected to reject the null hypothesis of no treatment group difference in 6 month hospital admissions, controlling for baseline hospital admissions.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.04Regression, Logistic
Secondary
Hospital Admissions at 9 Months
Number of participants who were admitted to a hospital in the past 3 months.
Time frame: Baseline, 9 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Calmer Life | Hospital Admissions at 9 Months | Baseline | 12 Participants |
| Calmer Life | Hospital Admissions at 9 Months | 9 months | 14 Participants |
| Enhanced Community Care | Hospital Admissions at 9 Months | Baseline | 10 Participants |
| Enhanced Community Care | Hospital Admissions at 9 Months | 9 months | 3 Participants |
Comparison: We expected to reject the null hypothesis of no treatment group difference in 9 month hospital admissions, controlling for baseline hospital admissions.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.001Regression, Logistic
Secondary
Insomnia Severity Index (ISI) at 6 Months
Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties.
Time frame: Baseline, 6 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Insomnia Severity Index (ISI) at 6 Months | Baseline | 13.44 units on a scale | Standard Deviation 6.84 |
| Calmer Life | Insomnia Severity Index (ISI) at 6 Months | 6 months | 10.08 units on a scale | Standard Deviation 8.08 |
| Enhanced Community Care | Insomnia Severity Index (ISI) at 6 Months | Baseline | 13.00 units on a scale | Standard Deviation 6.26 |
| Enhanced Community Care | Insomnia Severity Index (ISI) at 6 Months | 6 months | 10.13 units on a scale | Standard Deviation 7.16 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month ISI, controlling for baseline ISI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.64ANCOVA
Secondary
Insomnia Severity Index (ISI) at 9 Months
Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties.
Time frame: Baseline, 9 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Insomnia Severity Index (ISI) at 9 Months | Baseline | 13.44 units on a scale | Standard Deviation 6.84 |
| Calmer Life | Insomnia Severity Index (ISI) at 9 Months | 9 months | 9.81 units on a scale | Standard Deviation 7.65 |
| Enhanced Community Care | Insomnia Severity Index (ISI) at 9 Months | Baseline | 13.00 units on a scale | Standard Deviation 6.26 |
| Enhanced Community Care | Insomnia Severity Index (ISI) at 9 Months | 9 months | 9.51 units on a scale | Standard Deviation 6.86 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month ISI, controlling for baseline ISI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.35ANCOVA
Secondary
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months
Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning.
Time frame: Baseline, 6 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months | Baseline | 48.90 units on a scale | Standard Deviation 6.28 |
| Calmer Life | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months | 6 months | 51.05 units on a scale | Standard Deviation 7.3 |
| Enhanced Community Care | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months | Baseline | 48.05 units on a scale | Standard Deviation 7.23 |
| Enhanced Community Care | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months | 6 months | 49.83 units on a scale | Standard Deviation 6.94 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.52ANCOVA
Secondary
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months
Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning.
Time frame: Baseline, 9 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months | Baseline | 48.90 units on a scale | Standard Deviation 6.28 |
| Calmer Life | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months | 9 months | 50.85 units on a scale | Standard Deviation 8.05 |
| Enhanced Community Care | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months | Baseline | 48.05 units on a scale | Standard Deviation 7.23 |
| Enhanced Community Care | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months | 9 months | 49.64 units on a scale | Standard Deviation 8.97 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.92ANCOVA
Secondary
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation
Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning.
Time frame: Baseline, 9 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation | Baseline | 59.05 units on a scale | Standard Deviation 10.8 |
| Calmer Life | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation | 9 months | 62.30 units on a scale | Standard Deviation 13.86 |
| Enhanced Community Care | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation | Baseline | 59.39 units on a scale | Standard Deviation 10.43 |
| Enhanced Community Care | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation | 9 months | 62.45 units on a scale | Standard Deviation 13.51 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.89ANCOVA
Secondary
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months
Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning.
Time frame: Baseline, 6 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months | Baseline | 59.05 units on a scale | Standard Deviation 10.8 |
| Calmer Life | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months | 6 months | 64.54 units on a scale | Standard Deviation 16.97 |
| Enhanced Community Care | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months | Baseline | 59.39 units on a scale | Standard Deviation 10.43 |
| Enhanced Community Care | Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months | 6 months | 62.64 units on a scale | Standard Deviation 13.3 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.59ANCOVA
Secondary
Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS)
Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning.
Time frame: Baseline, 9 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) | Baseline | 38.38 units on a scale | Standard Deviation 12.47 |
| Calmer Life | Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) | 9 months | 38.37 units on a scale | Standard Deviation 13.26 |
| Enhanced Community Care | Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) | Baseline | 38.51 units on a scale | Standard Deviation 11.5 |
| Enhanced Community Care | Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) | 9 months | 36.93 units on a scale | Standard Deviation 12.71 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.94ANCOVA
Secondary
Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months
Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning.
Time frame: Baseline, 6 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months | Baseline | 38.38 units on a scale | Standard Deviation 12.47 |
| Calmer Life | Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months | 6 months | 37.86 units on a scale | Standard Deviation 12.09 |
| Enhanced Community Care | Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months | Baseline | 38.51 units on a scale | Standard Deviation 11.5 |
| Enhanced Community Care | Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months | 6 months | 36.45 units on a scale | Standard Deviation 11.95 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.64ANCOVA
Secondary
Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months
Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning.
Time frame: Baseline, 6 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months | Baseline | 40.08 units on a scale | Standard Deviation 9.71 |
| Calmer Life | Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months | 6 months | 47.25 units on a scale | Standard Deviation 12.17 |
| Enhanced Community Care | Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months | Baseline | 40.14 units on a scale | Standard Deviation 10.15 |
| Enhanced Community Care | Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months | 6 months | 45.91 units on a scale | Standard Deviation 10.94 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.98ANCOVA
Secondary
Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months
Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning.
Time frame: Baseline, 9 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months | Baseline | 40.08 units on a scale | Standard Deviation 9.71 |
| Calmer Life | Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months | 9 months | 46.98 units on a scale | Standard Deviation 10.46 |
| Enhanced Community Care | Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months | Baseline | 40.14 units on a scale | Standard Deviation 10.15 |
| Enhanced Community Care | Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months | 9 months | 47.27 units on a scale | Standard Deviation 11.57 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.88ANCOVA
Secondary
Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months
Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity.
Time frame: Baseline, 6 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months | Baseline | 11.41 units on a scale | Standard Deviation 6.08 |
| Calmer Life | Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months | 6 months | 7.28 units on a scale | Standard Deviation 6.48 |
| Enhanced Community Care | Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months | Baseline | 11.13 units on a scale | Standard Deviation 5.85 |
| Enhanced Community Care | Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months | 6 months | 8.48 units on a scale | Standard Deviation 6.06 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PHQ-8, controlling for baseline PHQ-8.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.52ANCOVA
Secondary
Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months
Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity.
Time frame: Baseline, 9 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months | Baseline | 11.41 units on a scale | Standard Deviation 6.08 |
| Calmer Life | Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months | 9 months | 7.39 units on a scale | Standard Deviation 6.35 |
| Enhanced Community Care | Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months | Baseline | 11.13 units on a scale | Standard Deviation 5.85 |
| Enhanced Community Care | Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months | 9 months | 7.00 units on a scale | Standard Deviation 5.58 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PHQ-8, controlling for baseline PHQ-8.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.29ANCOVA
Secondary
Psychological Service Use at 6 Months
Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months
Time frame: Baseline, 6 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Calmer Life | Psychological Service Use at 6 Months | Baseline | 42 Participants |
| Calmer Life | Psychological Service Use at 6 Months | 6 months | 31 Participants |
| Enhanced Community Care | Psychological Service Use at 6 Months | Baseline | 29 Participants |
| Enhanced Community Care | Psychological Service Use at 6 Months | 6 months | 31 Participants |
Comparison: We expected to reject the null hypothesis of no treatment group difference in 6 month psychological service use, controlling for baseline psychological service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.55Regression, Logistic
Secondary
Psychological Service Use at 9 Months
Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months
Time frame: Baseline, 9 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Calmer Life | Psychological Service Use at 9 Months | Baseline | 42 Participants |
| Calmer Life | Psychological Service Use at 9 Months | 9 months | 26 Participants |
| Enhanced Community Care | Psychological Service Use at 9 Months | Baseline | 29 Participants |
| Enhanced Community Care | Psychological Service Use at 9 Months | 9 months | 20 Participants |
Comparison: We expected to reject the null hypothesis of no treatment group difference in 9 month psychological service use, controlling for baseline psychological service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.54Regression, Logistic
Secondary
PTSD Checklist-5 (PCL-5) Total at 6 Months
Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity.
Time frame: Baseline, 6 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | PTSD Checklist-5 (PCL-5) Total at 6 Months | Baseline | 28.77 units on a scale | Standard Deviation 16.6 |
| Calmer Life | PTSD Checklist-5 (PCL-5) Total at 6 Months | 6 months | 26.92 units on a scale | Standard Deviation 16.16 |
| Enhanced Community Care | PTSD Checklist-5 (PCL-5) Total at 6 Months | Baseline | 18.02 units on a scale | Standard Deviation 18.85 |
| Enhanced Community Care | PTSD Checklist-5 (PCL-5) Total at 6 Months | 6 months | 20.35 units on a scale | Standard Deviation 16.11 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PCL-5, controlling for baseline PCL-5.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.31ANCOVA
Secondary
PTSD Checklist-5 (PCL-5) Total at 9 Months
Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity.
Time frame: Baseline, 9 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calmer Life | PTSD Checklist-5 (PCL-5) Total at 9 Months | Baseline | 28.77 units on a scale | Standard Deviation 16.6 |
| Calmer Life | PTSD Checklist-5 (PCL-5) Total at 9 Months | 9 months | 18.28 units on a scale | Standard Deviation 17.39 |
| Enhanced Community Care | PTSD Checklist-5 (PCL-5) Total at 9 Months | Baseline | 26.92 units on a scale | Standard Deviation 16.16 |
| Enhanced Community Care | PTSD Checklist-5 (PCL-5) Total at 9 Months | 9 months | 18.53 units on a scale | Standard Deviation 15.94 |
Comparison: Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PCL-5, controlling for baseline PCL-5.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.96ANCOVA
Secondary
Social Service or Resource Use at 6 Months
Number of participants who received social services or resources over the past 3 months
Time frame: Baseline, 6 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Calmer Life | Social Service or Resource Use at 6 Months | Baseline | 22 Participants |
| Calmer Life | Social Service or Resource Use at 6 Months | 6 months | 17 Participants |
| Enhanced Community Care | Social Service or Resource Use at 6 Months | Baseline | 17 Participants |
| Enhanced Community Care | Social Service or Resource Use at 6 Months | 6 months | 11 Participants |
Comparison: We expected to reject the null hypothesis of no treatment group difference in 6 month social service use, controlling for baseline social service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.42Regression, Logistic
Secondary
Social Service or Resource Use at 9 Months
Number of participants who received social services or resources over the past 3 months
Time frame: Baseline, 9 months
Population: 134 participants who completed baseline assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Calmer Life | Social Service or Resource Use at 9 Months | Baseline | 22 Participants |
| Calmer Life | Social Service or Resource Use at 9 Months | 9 months | 18 Participants |
| Enhanced Community Care | Social Service or Resource Use at 9 Months | Baseline | 17 Participants |
| Enhanced Community Care | Social Service or Resource Use at 9 Months | 9 months | 14 Participants |
Comparison: We expected to reject the null hypothesis of no treatment group difference in 9 month social service use, controlling for baseline social service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error ratep-value: 0.85Regression, Logistic