Calmer Life: Testing the Effectiveness of a Treatment for Anxiety

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01702220

First Posted: October 8, 2012

Last Update Posted: January 12, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Retirement Research Foundation

Archstone Foundation

Information provided by (Responsible Party):

Melinda Stanley, Baylor College of Medicine

Purpose

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	Intervention
Generalized Anxiety Disorder Anxiety Disorder NOS	Behavioral: CBT Other: ECC


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by Melinda Stanley, Baylor College of Medicine:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Estimated Enrollment:	60
Study Start Date:	October 2012
Study Completion Date:	August 2015
Primary Completion Date:	February 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702220

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


Responsible Party:	Melinda Stanley, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT01702220 History of Changes
Other Study ID Numbers:	H30928
First Submitted:	October 4, 2012
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

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