Calmer Life: A Worry Reduction Program for Older Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Baylor College of Medicine
Sponsor:
Information provided by (Responsible Party):
Melinda Stanley, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00932178
First received: July 1, 2009
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

Calmer Life is a research study for older adults with anxiety. In the program participants will have the opportunity to learn skills that may help cope with anxiety. Participants have the option of including religion and spirituality into the skill. Skills participants can learn include: how to relax, how to change the way you think about things, and how to solve problems more effectively.


Condition Intervention
Anxiety
Behavioral: Calmer Life

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Calmer Life: A Worry Reduction Program for Older Adults

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Geriatric Depression Scale (GDS), Geriatric Anxiety Inventory (GAI), Penn State Worry Questionnaire (PSWQ-A), State-Trait Anxiety Inventory (STAI) [ Time Frame: Baseline, 1-month, 2-month, 3-month, and 6-month ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calmer Life
Skills-based intervention to reduce anxiety and worry in adults age 50+.
Behavioral: Calmer Life
Calmer Life is a modified version of an existing Cognitive Behavioral Treatment manual. Participants have the option of including religion and spirituality into coping skills taught as a way of treating anxiety with or without depression in older adults.

Detailed Description:

Preliminary work in a related study (H-22763) suggests that a significant percentage of older patients think that incorporating religion and/or spirituality into counseling is important. Based on data from this study, available scholarly literature, and input from consultants, we have developed an initial version of Calmer Life that is sufficiently flexible to incorporate a range of religious and spiritual beliefs and coping skills based on each patient's unique values and beliefs. The manual for this treatment includes intervention components from evidence-based treatment for late-life anxiety (H-23798; H-15958), suggested strategies for incorporating religion or spirituality into the coping skills for anxiety and depression, and spiritually-based interventions (e.g., forgiveness, gratitude). Patients have a choice to include or not include religious or spiritually based components. The proposed project will begin to test this broad spiritually based CBT for older adults (Calmer Life) with Generalized Anxiety Disorder (GAD) with or without depression. Further modifications to the Calmer Life manual and in the treatment approach will be made based on patient, clinician, and consultant input.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 50+;
  • A principal or co-principal diagnosis of General Anxiety Disorder;
  • Interest in receiving CBT for anxiety/depression with the option of including religion and spirituality;
  • Must be English speaking

Exclusion Criteria:

  • Active suicidal intent;
  • Current psychosis or bipolar disorder;
  • Substance abuse within the last month
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932178

Contacts
Contact: Paula D Wagener, BA (713) 794-8831 pwagener@bcm.edu

Locations
United States, Texas
Michael E DeBakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Paula D Wagener, BA    713-794-8831    pwagener@bcm.edu   
Principal Investigator: Melinda A. Stanley, PhD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Melinda A. Stanley, PhD Michael E DeBakey VA Medical Center
  More Information

Publications:
Responsible Party: Melinda Stanley, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00932178     History of Changes
Other Study ID Numbers: MIRECC006, VA ID Number: 09E02.H
Study First Received: July 1, 2009
Last Updated: March 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Baylor College of Medicine:
Anxiety
Worry
nervousness
Older Adult

ClinicalTrials.gov processed this record on October 23, 2014