N/A
N=134
Calmer Life: Treating Worry Among Older Adults In Underserved, Low-income, Minority Communities
Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT02391363 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months — 26.73; 26.25; 22.04; 23.04 units on a scale — p=0.77
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive behavior treatment (Behavioral); Information and referral (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months |
26.73; 26.25; 22.04; 23.04 | 0.77 |
| PRIMARY Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months |
26.73; 26.25; 21.87; 20.18 | 0.07 |
| PRIMARY Generalized Anxiety Disorder-7 (GAD-7) at 6 Months |
11.00; 10.56; 7.13; 8.11 | 0.34 |
| PRIMARY Generalized Anxiety Disorder-7 (GAD-7) at 9 Months |
11.00; 10.56; 7.54; 6.62 | 0.08 |
| SECONDARY Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months |
3.39; 3.30; 2.25; 2.48 | 0.45 |
| SECONDARY Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months |
3.39; 3.30; 2.65; 2.31 | 0.13 |
| SECONDARY Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months |
11.41; 11.13; 7.28; 8.48 | 0.52 |
| SECONDARY Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months |
11.41; 11.13; 7.39; 7.00 | 0.29 |
| SECONDARY Geriatric Depression Scale Short Form (GDS) at 6 Months |
5.97; 5.61; 3.75; 4.33 | 0.14 |
| SECONDARY Geriatric Depression Scale Short Form (GDS) at 9 Months |
5.97; 5.61; 3.80; 3.92 | 0.59 |
| SECONDARY Insomnia Severity Index (ISI) at 6 Months |
13.44; 13.00; 10.08; 10.13 | 0.64 |
| SECONDARY Insomnia Severity Index (ISI) at 9 Months |
13.44; 13.00; 9.81; 9.51 | 0.35 |
| SECONDARY Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months |
48.90; 48.05; 51.05; 49.83 | 0.52 |
| SECONDARY Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months |
48.90; 48.05; 50.85; 49.64 | 0.92 |
| SECONDARY Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months |
59.05; 59.39; 64.54; 62.64 | 0.59 |
| SECONDARY Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation |
59.05; 59.39; 62.30; 62.45 | 0.89 |
| SECONDARY Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months |
38.38; 38.51; 37.86; 36.45 | 0.64 |
| SECONDARY Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) |
38.38; 38.51; 38.37; 36.93 | 0.94 |
| SECONDARY Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months |
40.08; 40.14; 47.25; 45.91 | 0.98 |
| SECONDARY Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months |
40.08; 40.14; 46.98; 47.27 | 0.88 |
| SECONDARY PTSD Checklist-5 (PCL-5) Total at 6 Months |
28.77; 18.02; 26.92; 20.35 | 0.31 |
| SECONDARY PTSD Checklist-5 (PCL-5) Total at 9 Months |
28.77; 26.92; 18.28; 18.53 | 0.96 |
| SECONDARY Health Service Use at 6 Months |
64; 56; 47; 45 | 0.52 |
| SECONDARY Health Service Use at 9 Months |
64; 56; 52; 39 | 0.04 sig |
| SECONDARY Hospital Admissions at 6 Months |
12; 10; 12; 5 | 0.04 sig |
| SECONDARY Hospital Admissions at 9 Months |
12; 10; 14; 3 | 0.001 sig |
| SECONDARY Social Service or Resource Use at 6 Months |
22; 17; 17; 11 | 0.42 |
| SECONDARY Social Service or Resource Use at 9 Months |
22; 17; 18; 14 | 0.85 |
| SECONDARY Psychological Service Use at 6 Months |
42; 29; 31; 31 | 0.55 |
| SECONDARY Psychological Service Use at 9 Months |
42; 29; 26; 20 | 0.54 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02391363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.