Calmer Life: Testing the Effectiveness of a Treatment for Anxiety

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Generalized Anxiety Disorder; Anxiety Disorder NOS	Behavioral: CBT; Other: ECC	Not Applicable

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Calmer Life: A Randomized Controlled Trial of a Participant-Centered Treatment for Anxiety in Low-Income, Older Adults
Study Start Date :	October 2012
Actual Primary Completion Date :	February 2015
Actual Study Completion Date :	August 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Geriatric Anxiety Inventory [ Time Frame: 3 months ]
2. Penn State Worry Questionnaire (PSWQ-A) [ Time Frame: 3 months ]
3. Generalized Anxiety Disorder-7 [ Time Frame: 3 months ]

Secondary Outcome Measures :

1. Patient Health Questionnaire-9 [ Time Frame: 3 months ]
2. Insomnia Severity Index [ Time Frame: 3 months ]
3. Late-Life Functional Disability Index [ Time Frame: 3 months ]
4. SF-12 Health Survey [ Time Frame: 3 months ]
5. Client Satisfaction Questionnaire [ Time Frame: 3 months ]
6. Brief RCOPE [ Time Frame: 3 months ]
   Religious coping
7. Health services use [ Time Frame: 3 months ]
8. Use of psychotropic medication [ Time Frame: 3 months ]
9. Brief Multidimensional Measure of Religiousness and Spirituality [ Time Frame: 3 months ]
10. Satisfaction with Life Scale [ Time Frame: 3 months ]
11. Geriatric Depression Scale [ Time Frame: 3 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Baylor College of Medicine

Retirement Research Foundation

Archstone Foundation

Investigators

Principal Investigator:	Melinda A Stanley, PhD	Baylor College of Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Melinda Stanley, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT01702220 History of Changes
Other Study ID Numbers:	H30928
First Posted:	October 8, 2012
Last Update Posted:	January 12, 2016
Last Verified:	January 2016

Keywords provided by Melinda Stanley, Baylor College of Medicine:

Generalized Anxiety Disorder; Geriatric

Additional relevant MeSH terms:

Disease; Anxiety Disorders; Pathologic Processes; Mental Disorders