Background: Despite high prevalence and negative public health impact, clinically significant worry is frequently unrecognized and untreated among older adults. Racial and ethnic minorities, many of whom live in underserved, low-income communities, are at particularly high risk for inadequate recognition and care. Calmer Life (CL) is an innovative, person-centered model of care anchored in evidence-based cognitive behavioral treatment with additional components to meet the needs of underserved older adults.
Objectives: The goal of the study was to determine whether CL improved worry and generalized anxiety disorder (GAD)-related symptoms (primary outcomes), measured with the Penn State Worry Questionnaire-Abbreviated (PSWQ-A) and the Generalized Anxiety Disorder 7-item (GAD-7) (both with adequate psychometric properties), and anxiety, depression, sleep, functional status, and quality of life (secondary outcomes) better than Enhanced Community Care (ECC) at posttreatment (6 months, primary end point), and whether effects of treatment were sustained at 9 months.
Methods: In the context of a community–academic partnership, we conducted a randomized controlled, comparative effectiveness trial of CL and ECC. We recruited 148 participants, aged 50 and older, with clinically significant worry from underserved neighborhoods with high prevalence of low-income minorities. Included participants were assigned randomly to CL or ECC, with a priori stratification by depression severity and age. Nontraditional counselors (community health workers, case managers) delivered CL and ECC. Treatment occurred over 6 months, with assessments at baseline and at 6 and 9 months. Primary analyses were intent-to-treat (ITT); another set of analyses was for completers and included only observed data.
Results: We analyzed data from 134 participants (70 CL and 64 ECC), most of whom were African American (75.6%), and with mean age of 66.7 years. ITT and completer analyses demonstrated similar and positive effects following CL and ECC on worry (CL: baseline M = 26.73 (SD, 7.53) and 6-month M = 22.04 (SD, 8.54), ECC: baseline M = 26.25 (SD, 6.93) and 6-month M = 23.04 (SD, 7.17) (PSWQ-A range: 8-40), F (1, 126.91) = 0.08, P = .77, d = 0.05; 95% CI, −0.29 to 0.39), GAD-related symptoms (CL: baseline M = 11.00 (SD, 5.42) and 6-month M = 7.13 (SD, 6.41), ECC: baseline M = 10.56 (SD, 5.11) and 6-month M = 8.11 (SD, 5.69) (GAD Range: 0-21), F (1, 73.64) = 0.92, P = .34, d = 0.17; 95% CI, −0.17 to 0.51), anxiety, depression, sleep, functional status, and mental health quality of life at 6 and 9 months. Physical health quality of life was unchanged. Satisfaction with CL was higher than satisfaction with ECC at 6 months. More participants in CL reported at least 1 hospital admission in the prior 3 months than in ECC at 6 and 9 months. At 9 months, more participants in CL reported at least 1 visit with a health care provider in the prior 3 months than in ECC.
Conclusions: This study highlights the need for community-based outreach and worry/anxiety screening in underserved populations. Cl and ECC produced generally similar and clinically important effects, and treatment fidelity data suggested good adherence in both treatment groups. Community agencies and faith-based organizations in underserved communities may choose to use either CL or ECC, or a combination of the 2, to offer services for older adults with identified worry/stress/anxiety.
Limitations: Given similar outcomes in CL and ECC, and the lack of prior trials that directly test the effectiveness of ECC for late-life anxiety, omission of a less active usual care comparison condition limits our ability to ascertain causality for CL or ECC treatment effects over time. Future research also may need to include larger samples to replicate and explore unexpected group differences on hospitalization rates and test potential moderator variables.
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