Trial record 12 of 758 for:    Open Studies | "Anxiety Disorders"

Calmer Life: Testing the Effectiveness of a Treatment for Anxiety

This study is currently recruiting participants.
Verified March 2013 by Baylor College of Medicine
Sponsor:
Collaborators:
Retirement Research Foundation
Archstone Foundation
Information provided by (Responsible Party):
Melinda Stanley, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01702220
First received: October 4, 2012
Last updated: March 27, 2013
Last verified: March 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Geriatric Anxiety Inventory [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Penn State Worry Questionnaire (PSWQ-A) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Generalized Anxiety Disorder-7 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Health Questionnaire-9 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Insomnia Severity Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Late-Life Functional Disability Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • SF-12 Health Survey [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Client Satisfaction Questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Brief RCOPE [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Religious coping

  • Health services use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Use of psychotropic medication [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Brief Multidimensional Measure of Religiousness and Spirituality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Satisfaction with Life Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Geriatric Depression Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702220

Contacts
Contact: Melinda A Stanley, PhD 713-794-8832 mstanley@bcm.edu
Contact: Paula Wagener, BA 713-794-8831 pwagener@bcm.edu

Locations
United States, Texas
Houston Center for Quality of Care and Utilization Studies Recruiting
Houston, Texas, United States, 77030
Contact: Melinda A Stanley, PhD    713-794-8832    mstanley@bcm.edu   
Contact: Paula Wagener, BA    713-794-8831    pwagener@bcm.edu   
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

No publications provided

Responsible Party: Melinda Stanley, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01702220     History of Changes
Other Study ID Numbers: H30928
Study First Received: October 4, 2012
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Generalized Anxiety Disorder
Geriatric

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014