N/A Completed N=134 Randomized Single-blind Treatment

Calmer Life: Treating Worry Among Older Adults In Underserved, Low-income, Minority Communities

Anxiety

Source: ClinicalTrials.gov NCT02391363 ↗

Enrolled (actual)

134

Serious AEs

0.0%

Results posted

May 2019

Primary outcomePrimary: 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

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.

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

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

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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. Informational only — not medical advice.