Calmer Life: Testing the Effectiveness of a Treatment for Anxiety

Study Overview
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Brief Summary
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The overall goals of the proposed research study are to: (1) examine quantitative outcomes in a well-conducted randomized clinical trial of Calmer Life, relative to Enhanced Community Care, an information and referral intervention that represents care in a real-world community-service environment, and (2) evaluate implementation feasibility, which includes training community providers; examining program reach, engagement, acceptability, and barriers-facilitators; and preparing practical tools for replicating the program.

Detailed Description
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Cognitive behavioral treatment (CBT) produces positive outcomes for late-life worry/GAD in academic and primary care settings, but minorities are significantly underrepresented in clinical trials, and standard CBT poorly addresses the needs of low-income minority older adults in underserved communities. More attention needs to be given to service delivery of anxiety treatments for underserved older adults. Calmer Life (CL) is a culturally tailored, participant-centered research study that offers a skills-based intervention for late-life anxiety and includes other elements of care to meet the needs of underserved, minority older adults, including the option to integrate religion/spirituality (R/S), flexible delivery modes, and modular treatment format. Participants will be randomly assigned to CL or Enhanced Community Care(ECC). CL and ECC will be provided by behavioral health clinicians recruited from partner organizations, psychology trainees, and other research staff over 3 months. Assessments will occur at baseline and 3 months. Participants in the CL condition can choose up to 12 individual skill sessions, and will be recommended to complete a minimum of 6 sessions. If participants desire to incorporate R/S, an R/S assessment occurs during session 2 to help the provider understand the participant's beliefs and practices. R/S can be integrated into any of the skills learned during the intervention (e.g., deep breathing, self-statements, sleep management) or omitted entirely. Participants in the ECC condition will receive brief biweekly check in calls to provide information about community resources (including mental health), offer emotional support, and assess symptom severity and need for crisis intervention. Emergency procedures will be followed in crisis situations. After 3 months of ECC is completed, participants in the ECC group will be offered the CL intervention. Outcome measures will be administered for participants in both groups at baseline, 1 month, and 3 months. Participants in ECC will complete measures at 6 months after completion of CL.

Official Title
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Calmer Life: A Randomized Controlled Trial of a Participant-Centered Treatment for Anxiety in Low-Income, Older Adults

Conditions
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Generalized Anxiety Disorder, Anxiety Disorder NOS

Intervention / Treatment
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* Behavioral: CBT
* Other: ECC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50 and older Principal or Co-principal diagnosis of GAD or ADNOS Must speak English Must have a health care or social service provider and provide written authorization to research team to communicate with their health-care or social service provider Must live, work, worship, attend community functions, and/or receive health care in target geographic areas Exclusion Criteria: Active suicidal intent Current psychosis Mania or substance abuse within the last month Cognitive impairment according to a Mini Cog screener score of 3 or lower

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT<br> | Behavioral: CBT<br>* 6-12 sessions of CBT in person or over the phone<br>* Other names: Cognitive Behavior Treatment, Cognitive Behavior Therapy;|
| Active Comparator: Enhanced Community Care (ECC)<br> | Other: ECC<br>* 6 biweekly sessions of ECC over the telephone<br>* Other names: Enhanced Community Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geriatric Anxiety Inventory |  | 3 months | 
| Penn State Worry Questionnaire (PSWQ-A) |  | 3 months | 
| Generalized Anxiety Disorder-7 |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 |  | 3 months | 
| Insomnia Severity Index |  | 3 months | 
| Late-Life Functional Disability Index |  | 3 months | 
| SF-12 Health Survey |  | 3 months | 
| Client Satisfaction Questionnaire |  | 3 months | 
| Brief RCOPE | Religious coping | 3 months | 
| Health services use |  | 3 months | 
| Use of psychotropic medication |  | 3 months | 
| Brief Multidimensional Measure of Religiousness and Spirituality |  | 3 months | 
| Satisfaction with Life Scale |  | 3 months | 
| Geriatric Depression Scale |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized Anxiety Disorder, Geriatric