Calmer Life: A Worry Reduction Program for Older Adults

Sponsor
Baylor College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00932178
Collaborator
(none)
32
1
1
82
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Study Details

Study Description

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 Phase
  • Behavioral: Calmer Life
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
N/A
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 :
Apr 1, 2009
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Michael E DeBakey VA Medical Center Houston Texas United States 77030

Sponsors and Collaborators

  • Baylor College of Medicine

Investigators

  • Principal Investigator: Melinda A. Stanley, PhD, Michael E. DeBakey VA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Melinda Stanley, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00932178
Other Study ID Numbers:
  • MIRECC006
  • VA ID Number: 09E02.H
First Posted:
Jul 3, 2009
Last Update Posted:
Jan 23, 2018
Last Verified:
Jan 1, 2018
Keywords provided by Melinda Stanley, Professor, Baylor College of Medicine

Study Results

No Results Posted as of Jan 23, 2018