Calmer Life: Testing the Effectiveness of a Treatment for Anxiety

Not Applicable

Completed

• Conditions: Generalized Anxiety Disorder; Anxiety Disorder NOS
• Interventions: Behavioral: CBT; Other: ECC

• Registration Number: NCT01702220
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2012-10-05
• Study First Posted: 2012-10-08
• Primary Completion: 2015-02
• Study Completion: 2015-08
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT	CBT	-
Enhanced Community Care (ECC)	ECC	-

Primary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder-7	3 months
Penn State Worry Questionnaire (PSWQ-A)	3 months
Geriatric Anxiety Inventory	3 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Houston Center for Quality of Care and Utilization Studies; 🇺🇸 Houston, Texas, United States