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Calmer Life: A Worry Reduction Program for Older Adults

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.
ClinicalTrials.gov Identifier: NCT00932178
Recruitment Status : Completed
First Posted : July 3, 2009
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
Melinda Stanley, Baylor College of Medicine

Brief Summary:
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 or disease Intervention/treatment
Anxiety Behavioral: Calmer Life

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Calmer Life: A Worry Reduction Program for Older Adults
Study Start Date : April 2009
Primary Completion Date : February 2016
Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

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

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

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): NCT00932178

United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Principal Investigator: Melinda A. Stanley, PhD Michael E DeBakey VA Medical Center

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 ( Other Identifier: MEDVAMC Research & Development Committe )
First Posted: July 3, 2009    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by Melinda Stanley, Baylor College of Medicine:
Older Adult