Calmer Life: A Worry Reduction Program for Older Adults
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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 |
- 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 |
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| Contact: Paula D Wagener, BA | (713) 794-8831 | pwagener@bcm.edu |
| 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 | |
| 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 |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013