NCT00932178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2009

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

6.8 years

First QC Date

July 1, 2009

Last Update Submit

January 18, 2018

Conditions

Keywords

AnxietyWorrynervousnessOlder Adult

Outcome Measures

Primary Outcomes (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

Study Arms (1)

Calmer Life

EXPERIMENTAL

Skills-based intervention to reduce anxiety and worry in adults age 50+.

Behavioral: Calmer Life

Interventions

Calmer LifeBEHAVIORAL

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.

Calmer Life

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Active suicidal intent;
  • Current psychosis or bipolar disorder;
  • Substance abuse within the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 22416908BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Melinda A. Stanley, PhD

    Michael E. DeBakey VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 1, 2009

First Posted

July 3, 2009

Study Start

April 1, 2009

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations