Calmer Life: A Worry Reduction Program for Older Adults

January 18, 2018 updated by: Melinda Stanley, Baylor College of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E DeBakey VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, 1-month, 2-month, 3-month, and 6-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

July 1, 2009

First Submitted That Met QC Criteria

July 1, 2009

First Posted (ESTIMATE)

July 3, 2009

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MIRECC006
  • VA ID Number: 09E02.H (OTHER: MEDVAMC Research & Development Committe)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety

Clinical Trials on Calmer Life

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe