Calmer Life: Testing the Effectiveness of a Treatment for Anxiety

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

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder; Anxiety Disorder NOS
• Intervention / Treatment: Behavioral: CBT; Other: ECC

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Center for Quality of Care and Utilization Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Retirement Research Foundation; Archstone Foundation
• Investigators: Principal Investigator: Melinda A Stanley, PhD, Baylor College of Medicine

Publications and helpful links

General Publications

• Stanley MA, Wilson N, Shrestha S, Amspoker AB, Armento M, Cummings JP, Evans-Hudnall G, Wagener P, Kunik ME. Calmer Life: A Culturally Tailored Intervention for Anxiety in Underserved Older Adults. Am J Geriatr Psychiatry. 2016 Aug;24(8):648-658. doi: 10.1016/j.jagp.2016.03.008. Epub 2016 Mar 29.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 4, 2012
• First Submitted That Met QC Criteria: October 5, 2012
• First Posted (Estimate): October 8, 2012

Study Record Updates

• Last Update Posted (Estimate): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Generalized Anxiety Disorder; Geriatric
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders
• Other Study ID Numbers: H30928