Clinical trial NCT00932178: Calmer Life: A Worry Reduction Program for Older Adults
Official title: Calmer Life: A Worry Reduction Program for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Worry
nervousness
Older Adult
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2009-07-03
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Geriatric Depression Scale (GDS), Geriatric Anxiety Inventory (GAI), Penn State Worry Questionnaire (PSWQ-A), State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline, 1-month, 2-month, 3-month, and 6-month
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center
name: Melinda A. Stanley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jameson JP, Shrestha S, Escamilla M, Clark S, Wilson N, Kunik M, Zeno D, Harris TB, Peters A, Varner IL, Scantlebury C, Scott-Gurnell K, Stanley M. Establishing community partnerships to support late-life anxiety research: lessons learned from the Calmer Life project. Aging Ment Health. 2012;16(7):874-83. doi: 10.1080/13607863.2012.660621. Epub 2012 Mar 15.