Calmer Life: A Worry Reduction Program for Older Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Calmer Life: A Worry Reduction Program for Older Adults

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: Calmer Life


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calmer Life<br>Skills-based intervention to reduce anxiety and worry in adults age 50+. | Behavioral: Calmer Life<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geriatric Depression Scale (GDS), Geriatric Anxiety Inventory (GAI), Penn State Worry Questionnaire (PSWQ-A), State-Trait Anxiety Inventory (STAI) |  | Baseline, 1-month, 2-month, 3-month, and 6-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Worry, nervousness, Older Adult