Trial Outcomes & Findings for Calmer Life: Treating Worry Among Older Adults In Underserved, Low-income, Minority Communities (NCT NCT02391363)
NCT ID: NCT02391363
Last Updated: 2019-05-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
247 participants
Primary outcome timeframe
Baseline, 6 months
Results posted on
2019-05-31
Participant Flow
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.
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.
Participant milestones
| Measure |
Calmer Life
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
64
|
|
Overall Study
COMPLETED
|
59
|
56
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
| Measure |
Calmer Life
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
Baseline Characteristics
The ERS was administered separately from other baseline measures, and not all participants were reached to complete this measure.
Baseline characteristics by cohort
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.69 years
STANDARD_DEVIATION 9.394 • n=70 Participants
|
67.14 years
STANDARD_DEVIATION 9.127 • n=64 Participants
|
66.90 years
STANDARD_DEVIATION 9.235 • n=134 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=70 Participants
|
48 Participants
n=64 Participants
|
109 Participants
n=134 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=70 Participants
|
16 Participants
n=64 Participants
|
25 Participants
n=134 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=70 Participants
|
3 Participants
n=64 Participants
|
6 Participants
n=134 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=70 Participants
|
61 Participants
n=64 Participants
|
128 Participants
n=134 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=70 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=134 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=70 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=134 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=70 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=134 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=70 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=134 Participants
|
|
Race (NIH/OMB)
Black or African American
|
49 Participants
n=70 Participants
|
54 Participants
n=64 Participants
|
103 Participants
n=134 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=70 Participants
|
10 Participants
n=64 Participants
|
28 Participants
n=134 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=70 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=134 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=70 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=134 Participants
|
|
Region of Enrollment
United States
|
70 Participants
n=70 Participants
|
64 Participants
n=64 Participants
|
134 Participants
n=134 Participants
|
|
Years of Education
|
13.91 years
STANDARD_DEVIATION 2.853 • n=70 Participants
|
13.28 years
STANDARD_DEVIATION 2.740 • n=64 Participants
|
13.61 years
STANDARD_DEVIATION 2.807 • n=134 Participants
|
|
Marital Status
Married
|
18 Participants
n=70 Participants
|
15 Participants
n=64 Participants
|
33 Participants
n=134 Participants
|
|
Marital Status
Never Married
|
7 Participants
n=70 Participants
|
11 Participants
n=64 Participants
|
18 Participants
n=134 Participants
|
|
Marital Status
Separated
|
3 Participants
n=70 Participants
|
2 Participants
n=64 Participants
|
5 Participants
n=134 Participants
|
|
Marital Status
Divorced
|
29 Participants
n=70 Participants
|
20 Participants
n=64 Participants
|
49 Participants
n=134 Participants
|
|
Marital Status
Widowed
|
13 Participants
n=70 Participants
|
16 Participants
n=64 Participants
|
29 Participants
n=134 Participants
|
|
Income
<$10,000
|
13 Participants
n=70 Participants
|
23 Participants
n=64 Participants
|
36 Participants
n=134 Participants
|
|
Income
$10,000 - $20,000
|
29 Participants
n=70 Participants
|
24 Participants
n=64 Participants
|
53 Participants
n=134 Participants
|
|
Income
$20,000 - $30,000
|
11 Participants
n=70 Participants
|
8 Participants
n=64 Participants
|
19 Participants
n=134 Participants
|
|
Income
$30,000 - $40,000
|
8 Participants
n=70 Participants
|
4 Participants
n=64 Participants
|
12 Participants
n=134 Participants
|
|
Income
$40,000 - $50,000
|
3 Participants
n=70 Participants
|
3 Participants
n=64 Participants
|
6 Participants
n=134 Participants
|
|
Income
$50,000 - $60,000
|
5 Participants
n=70 Participants
|
1 Participants
n=64 Participants
|
6 Participants
n=134 Participants
|
|
Income
≥$60,000
|
1 Participants
n=70 Participants
|
1 Participants
n=64 Participants
|
2 Participants
n=134 Participants
|
|
Psychotropic Medication Use
Any psychotropic
|
21 Participants
n=70 Participants
|
18 Participants
n=64 Participants
|
39 Participants
n=134 Participants
|
|
Psychotropic Medication Use
Anti-anxiety
|
7 Participants
n=70 Participants
|
7 Participants
n=64 Participants
|
14 Participants
n=134 Participants
|
|
Psychotropic Medication Use
Anti-depressant
|
16 Participants
n=70 Participants
|
13 Participants
n=64 Participants
|
29 Participants
n=134 Participants
|
|
Psychotropic Medication Use
Anti-psychotic
|
4 Participants
n=70 Participants
|
1 Participants
n=64 Participants
|
5 Participants
n=134 Participants
|
|
Psychotropic Medication Use
Hypnotic/Sleep
|
7 Participants
n=70 Participants
|
7 Participants
n=64 Participants
|
14 Participants
n=134 Participants
|
|
Medication Use, Total
Psychotropic
|
0.50 number of medications
STANDARD_DEVIATION 0.897 • n=70 Participants
|
0.44 number of medications
STANDARD_DEVIATION 0.778 • n=64 Participants
|
0.47 number of medications
STANDARD_DEVIATION 0.840 • n=134 Participants
|
|
Medication Use, Total
Non-psychotropic
|
4.64 number of medications
STANDARD_DEVIATION 3.323 • n=70 Participants
|
4.51 number of medications
STANDARD_DEVIATION 3.671 • n=64 Participants
|
4.58 number of medications
STANDARD_DEVIATION 3.480 • n=134 Participants
|
|
Diagnoses
None recorded
|
5 Participants
n=70 Participants
|
4 Participants
n=64 Participants
|
9 Participants
n=134 Participants
|
|
Diagnoses
Generalized Anxiety Disorder (GAD)
|
57 Participants
n=70 Participants
|
45 Participants
n=64 Participants
|
102 Participants
n=134 Participants
|
|
Diagnoses
Any Depressive Disorder
|
35 Participants
n=70 Participants
|
34 Participants
n=64 Participants
|
69 Participants
n=134 Participants
|
|
Diagnoses
Post Traumatic Stress Dissorder (PTSD)
|
5 Participants
n=70 Participants
|
3 Participants
n=64 Participants
|
8 Participants
n=134 Participants
|
|
Diagnoses
Social Phobia
|
13 Participants
n=70 Participants
|
19 Participants
n=64 Participants
|
32 Participants
n=134 Participants
|
|
Diagnoses
Specific Phobia
|
26 Participants
n=70 Participants
|
33 Participants
n=64 Participants
|
59 Participants
n=134 Participants
|
|
Diagnoses
Other Specificied Anxiety Disorder (OSAD) (GAD)
|
4 Participants
n=70 Participants
|
10 Participants
n=64 Participants
|
14 Participants
n=134 Participants
|
|
Diagnoses
OSAD (Other)
|
3 Participants
n=70 Participants
|
3 Participants
n=64 Participants
|
6 Participants
n=134 Participants
|
|
Diagnoses
Panic
|
4 Participants
n=70 Participants
|
2 Participants
n=64 Participants
|
6 Participants
n=134 Participants
|
|
Service Use
Health Services
|
64 Participants
n=70 Participants
|
56 Participants
n=64 Participants
|
120 Participants
n=134 Participants
|
|
Service Use
Hospital Admissions
|
12 Participants
n=70 Participants
|
10 Participants
n=64 Participants
|
22 Participants
n=134 Participants
|
|
Service Use
Social Services
|
22 Participants
n=70 Participants
|
17 Participants
n=64 Participants
|
39 Participants
n=134 Participants
|
|
Service Use
Psychological Services
|
42 Participants
n=70 Participants
|
29 Participants
n=64 Participants
|
71 Participants
n=134 Participants
|
|
Expectancy Rating Scale (ERS) Cred
|
26.34 units on a scale
STANDARD_DEVIATION 4.213 • n=64 Participants • The ERS was administered separately from other baseline measures, and not all participants were reached to complete this measure.
|
25.03 units on a scale
STANDARD_DEVIATION 5.688 • n=58 Participants • The ERS was administered separately from other baseline measures, and not all participants were reached to complete this measure.
|
25.72 units on a scale
STANDARD_DEVIATION 4.991 • n=122 Participants • The ERS was administered separately from other baseline measures, and not all participants were reached to complete this measure.
|
|
Expectancy Rating Scale (ERS) Exp
|
8.58 units on a scale
STANDARD_DEVIATION 1.762 • n=64 Participants • The ERS was administered separately from other baseline measures, and not all participants were reached to complete this measure.
|
7.69 units on a scale
STANDARD_DEVIATION 2.650 • n=58 Participants • The ERS was administered separately from other baseline measures, and not all participants were reached to complete this measure.
|
8.16 units on a scale
STANDARD_DEVIATION 2.264 • n=122 Participants • The ERS was administered separately from other baseline measures, and not all participants were reached to complete this measure.
|
|
Penn State Worry Questionnaire-A (PSWQ-A)
|
26.73 units on a scale
STANDARD_DEVIATION 7.535 • n=70 Participants
|
26.25 units on a scale
STANDARD_DEVIATION 6.933 • n=64 Participants
|
26.50 units on a scale
STANDARD_DEVIATION 7.231 • n=134 Participants
|
|
Generalized Anxiety Disorder-7 (GAD-7)
|
11.00 units on a scale
STANDARD_DEVIATION 5.421 • n=70 Participants
|
10.56 units on a scale
STANDARD_DEVIATION 5.108 • n=64 Participants
|
10.79 units on a scale
STANDARD_DEVIATION 5.259 • n=134 Participants
|
|
Geriatric Anxiety Inventory-SF (GAI-SF)
|
3.39 units on a scale
STANDARD_DEVIATION 1.544 • n=70 Participants
|
3.30 units on a scale
STANDARD_DEVIATION 1.752 • n=64 Participants
|
3.34 units on a scale
STANDARD_DEVIATION 1.641 • n=134 Participants
|
|
Geriatric Depression Scale Short Form (GDS)
|
5.97 units on a scale
STANDARD_DEVIATION 3.547 • n=70 Participants
|
5.61 units on a scale
STANDARD_DEVIATION 3.697 • n=64 Participants
|
5.80 units on a scale
STANDARD_DEVIATION 3.610 • n=134 Participants
|
|
Insomnia Severity Index (ISI)
|
13.44 units on a scale
STANDARD_DEVIATION 6.841 • n=70 Participants
|
13.00 units on a scale
STANDARD_DEVIATION 6.264 • n=64 Participants
|
13.23 units on a scale
STANDARD_DEVIATION 6.551 • n=134 Participants
|
|
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency
|
48.90 units on a scale
STANDARD_DEVIATION 6.281 • n=70 Participants
|
48.05 units on a scale
STANDARD_DEVIATION 7.231 • n=64 Participants
|
48.49 units on a scale
STANDARD_DEVIATION 6.739 • n=134 Participants
|
|
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation
|
59.05 units on a scale
STANDARD_DEVIATION 10.799 • n=70 Participants
|
59.38 units on a scale
STANDARD_DEVIATION 10.429 • n=64 Participants
|
59.21 units on a scale
STANDARD_DEVIATION 10.585 • n=134 Participants
|
|
PTSD Checklist-5 (PCL-5) Total
|
28.77 units on a scale
STANDARD_DEVIATION 16.601 • n=70 Participants
|
26.92 units on a scale
STANDARD_DEVIATION 16.157 • n=64 Participants
|
27.89 units on a scale
STANDARD_DEVIATION 16.355 • n=134 Participants
|
|
Patient Health Questionnaire depression scale (PHQ 8)
|
11.41 units on a scale
STANDARD_DEVIATION 6.076 • n=70 Participants
|
11.13 units on a scale
STANDARD_DEVIATION 5.849 • n=64 Participants
|
11.28 units on a scale
STANDARD_DEVIATION 5.948 • n=134 Participants
|
|
Brief RCOPE Positive Subscale
|
24.22 units on a scale
STANDARD_DEVIATION 4.702 • n=58 Participants • The Brief RCOPE was added to the study protocol after enrollment was underway, so data are not available for the full sample
|
23.84 units on a scale
STANDARD_DEVIATION 4.144 • n=55 Participants • The Brief RCOPE was added to the study protocol after enrollment was underway, so data are not available for the full sample
|
24.04 units on a scale
STANDARD_DEVIATION 4.424 • n=113 Participants • The Brief RCOPE was added to the study protocol after enrollment was underway, so data are not available for the full sample
|
|
Brief RCOPE Negative subscale
|
10.38 units on a scale
STANDARD_DEVIATION 4.815 • n=58 Participants • The Brief RCOPE was added to the study protocol after enrollment was underway, so data are not available for the full sample
|
10.96 units on a scale
STANDARD_DEVIATION 5.044 • n=55 Participants • The Brief RCOPE was added to the study protocol after enrollment was underway, so data are not available for the full sample
|
10.66 units on a scale
STANDARD_DEVIATION 4.915 • n=113 Participants • The Brief RCOPE was added to the study protocol after enrollment was underway, so data are not available for the full sample
|
|
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 • n=70 Participants
|
38.51 units on a scale
STANDARD_DEVIATION 11.498 • n=64 Participants
|
38.44 units on a scale
STANDARD_DEVIATION 11.969 • n=134 Participants
|
|
Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS)
|
40.08 units on a scale
STANDARD_DEVIATION 9.708 • n=70 Participants
|
40.14 units on a scale
STANDARD_DEVIATION 10.150 • n=64 Participants
|
40.11 units on a scale
STANDARD_DEVIATION 9.884 • n=134 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months
Baseline
|
26.73 units on a scale
Standard Deviation 7.53
|
26.25 units on a scale
Standard Deviation 6.93
|
|
Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months
6 months
|
22.04 units on a scale
Standard Deviation 8.54
|
23.04 units on a scale
Standard Deviation 7.17
|
PRIMARY outcome
Timeframe: Baseline, 9 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months
Baseline
|
26.73 units on a scale
Standard Deviation 7.53
|
26.25 units on a scale
Standard Deviation 6.93
|
|
Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months
9 months
|
21.87 units on a scale
Standard Deviation 8.72
|
20.18 units on a scale
Standard Deviation 7.70
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Generalized Anxiety Disorder-7 (GAD-7) at 6 Months
Baseline
|
11.00 units on a scale
Standard Deviation 5.42
|
10.56 units on a scale
Standard Deviation 5.11
|
|
Generalized Anxiety Disorder-7 (GAD-7) at 6 Months
6 months
|
7.13 units on a scale
Standard Deviation 6.41
|
8.11 units on a scale
Standard Deviation 5.69
|
PRIMARY outcome
Timeframe: Baseline, 9 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Generalized Anxiety Disorder-7 (GAD-7) at 9 Months
Baseline
|
11.00 units on a scale
Standard Deviation 5.42
|
10.56 units on a scale
Standard Deviation 5.11
|
|
Generalized Anxiety Disorder-7 (GAD-7) at 9 Months
9 months
|
7.54 units on a scale
Standard Deviation 5.51
|
6.62 units on a scale
Standard Deviation 5.66
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months
Baseline
|
3.39 units on a scale
Standard Deviation 1.54
|
3.30 units on a scale
Standard Deviation 1.75
|
|
Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months
6 months
|
2.25 units on a scale
Standard Deviation 2.00
|
2.48 units on a scale
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: Baseline, 9 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months
Baseline
|
3.39 units on a scale
Standard Deviation 1.54
|
3.30 units on a scale
Standard Deviation 1.75
|
|
Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months
9 months
|
2.65 units on a scale
Standard Deviation 2.11
|
2.31 units on a scale
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months
Baseline
|
11.41 units on a scale
Standard Deviation 6.08
|
11.13 units on a scale
Standard Deviation 5.85
|
|
Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months
6 months
|
7.28 units on a scale
Standard Deviation 6.48
|
8.48 units on a scale
Standard Deviation 6.06
|
SECONDARY outcome
Timeframe: Baseline, 9 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months
Baseline
|
11.41 units on a scale
Standard Deviation 6.08
|
11.13 units on a scale
Standard Deviation 5.85
|
|
Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months
9 months
|
7.39 units on a scale
Standard Deviation 6.35
|
7.00 units on a scale
Standard Deviation 5.58
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Geriatric Depression Scale Short Form (GDS) at 6 Months
Baseline
|
5.97 units on a scale
Standard Deviation 3.55
|
5.61 units on a scale
Standard Deviation 3.70
|
|
Geriatric Depression Scale Short Form (GDS) at 6 Months
6 months
|
3.75 units on a scale
Standard Deviation 3.42
|
4.33 units on a scale
Standard Deviation 3.44
|
SECONDARY outcome
Timeframe: Baseline, 9 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Geriatric Depression Scale Short Form (GDS) at 9 Months
Baseline
|
5.97 units on a scale
Standard Deviation 3.55
|
5.61 units on a scale
Standard Deviation 3.70
|
|
Geriatric Depression Scale Short Form (GDS) at 9 Months
9 months
|
3.80 units on a scale
Standard Deviation 3.49
|
3.92 units on a scale
Standard Deviation 3.19
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Insomnia Severity Index (ISI) at 6 Months
Baseline
|
13.44 units on a scale
Standard Deviation 6.84
|
13.00 units on a scale
Standard Deviation 6.26
|
|
Insomnia Severity Index (ISI) at 6 Months
6 months
|
10.08 units on a scale
Standard Deviation 8.08
|
10.13 units on a scale
Standard Deviation 7.16
|
SECONDARY outcome
Timeframe: Baseline, 9 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Insomnia Severity Index (ISI) at 9 Months
Baseline
|
13.44 units on a scale
Standard Deviation 6.84
|
13.00 units on a scale
Standard Deviation 6.26
|
|
Insomnia Severity Index (ISI) at 9 Months
9 months
|
9.81 units on a scale
Standard Deviation 7.65
|
9.51 units on a scale
Standard Deviation 6.86
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
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
|
48.05 units on a scale
Standard Deviation 7.23
|
|
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months
6 months
|
51.05 units on a scale
Standard Deviation 7.30
|
49.83 units on a scale
Standard Deviation 6.94
|
SECONDARY outcome
Timeframe: Baseline, 9 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
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
|
48.05 units on a scale
Standard Deviation 7.23
|
|
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
|
49.64 units on a scale
Standard Deviation 8.97
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months
Baseline
|
59.05 units on a scale
Standard Deviation 10.80
|
59.39 units on a scale
Standard Deviation 10.43
|
|
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
|
62.64 units on a scale
Standard Deviation 13.30
|
SECONDARY outcome
Timeframe: Baseline, 9 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation
Baseline
|
59.05 units on a scale
Standard Deviation 10.80
|
59.39 units on a scale
Standard Deviation 10.43
|
|
Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation
9 months
|
62.30 units on a scale
Standard Deviation 13.86
|
62.45 units on a scale
Standard Deviation 13.51
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
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
|
38.51 units on a scale
Standard Deviation 11.50
|
|
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
|
36.45 units on a scale
Standard Deviation 11.95
|
SECONDARY outcome
Timeframe: Baseline, 9 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
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
|
38.51 units on a scale
Standard Deviation 11.50
|
|
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
|
36.93 units on a scale
Standard Deviation 12.71
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
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
|
40.14 units on a scale
Standard Deviation 10.15
|
|
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
|
45.91 units on a scale
Standard Deviation 10.94
|
SECONDARY outcome
Timeframe: Baseline, 9 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
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
|
40.14 units on a scale
Standard Deviation 10.15
|
|
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
|
47.27 units on a scale
Standard Deviation 11.57
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
PTSD Checklist-5 (PCL-5) Total at 6 Months
Baseline
|
28.77 units on a scale
Standard Deviation 16.60
|
18.02 units on a scale
Standard Deviation 18.85
|
|
PTSD Checklist-5 (PCL-5) Total at 6 Months
6 months
|
26.92 units on a scale
Standard Deviation 16.16
|
20.35 units on a scale
Standard Deviation 16.11
|
SECONDARY outcome
Timeframe: Baseline, 9 monthsPopulation: 134 participants who completed baseline assessment.
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.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
PTSD Checklist-5 (PCL-5) Total at 9 Months
Baseline
|
28.77 units on a scale
Standard Deviation 16.60
|
26.92 units on a scale
Standard Deviation 16.16
|
|
PTSD Checklist-5 (PCL-5) Total at 9 Months
9 months
|
18.28 units on a scale
Standard Deviation 17.39
|
18.53 units on a scale
Standard Deviation 15.94
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 134 participants who completed baseline assessment.
Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Health Service Use at 6 Months
Baseline
|
64 Participants
|
56 Participants
|
|
Health Service Use at 6 Months
6 months
|
47 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Baseline, 9 monthsPopulation: 134 participants who completed baseline assessment.
Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Health Service Use at 9 Months
Baseline
|
64 Participants
|
56 Participants
|
|
Health Service Use at 9 Months
9 months
|
52 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 134 participants who completed baseline assessment.
Number of participants who were admitted to a hospital in the past 3 months.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Hospital Admissions at 6 Months
Baseline
|
12 Participants
|
10 Participants
|
|
Hospital Admissions at 6 Months
6 months
|
12 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline, 9 monthsPopulation: 134 participants who completed baseline assessment.
Number of participants who were admitted to a hospital in the past 3 months.
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Hospital Admissions at 9 Months
Baseline
|
12 Participants
|
10 Participants
|
|
Hospital Admissions at 9 Months
9 months
|
14 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 134 participants who completed baseline assessment.
Number of participants who received social services or resources over the past 3 months
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Social Service or Resource Use at 6 Months
Baseline
|
22 Participants
|
17 Participants
|
|
Social Service or Resource Use at 6 Months
6 months
|
17 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline, 9 monthsPopulation: 134 participants who completed baseline assessment.
Number of participants who received social services or resources over the past 3 months
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Social Service or Resource Use at 9 Months
Baseline
|
22 Participants
|
17 Participants
|
|
Social Service or Resource Use at 9 Months
9 months
|
18 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 134 participants who completed baseline assessment.
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
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Psychological Service Use at 6 Months
Baseline
|
42 Participants
|
29 Participants
|
|
Psychological Service Use at 6 Months
6 months
|
31 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Baseline, 9 monthsPopulation: 134 participants who completed baseline assessment.
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
Outcome measures
| Measure |
Calmer Life
n=70 Participants
Cognitive behavior treatment for anxiety
Cognitive behavior treatment: Anxiety management skills with the option to included religious/spiritual beliefs and practices
|
Enhanced Community Care
n=64 Participants
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
|
|---|---|---|
|
Psychological Service Use at 9 Months
Baseline
|
42 Participants
|
29 Participants
|
|
Psychological Service Use at 9 Months
9 months
|
26 Participants
|
20 Participants
|
Adverse Events
Calmer Life
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Community Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place