search
Back to results

Calmer Life: Testing the Effectiveness of a Treatment for Anxiety

Primary Purpose

Generalized Anxiety Disorder, Anxiety Disorder NOS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT
ECC
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Generalized Anxiety Disorder, Geriatric

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 50 and older
  • Principal or Co-principal diagnosis of GAD or ADNOS
  • Must speak English
  • Must have a health care or social service provider and provide written authorization to research team to communicate with their health-care or social service provider
  • Must live, work, worship, attend community functions, and/or receive health care in target geographic areas

Exclusion Criteria:

  • Active suicidal intent
  • Current psychosis
  • Mania or substance abuse within the last month
  • Cognitive impairment according to a Mini Cog screener score of 3 or lower

Sites / Locations

  • Houston Center for Quality of Care and Utilization Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT

Enhanced Community Care (ECC)

Arm Description

Outcomes

Primary Outcome Measures

Geriatric Anxiety Inventory
Penn State Worry Questionnaire (PSWQ-A)
Generalized Anxiety Disorder-7

Secondary Outcome Measures

Patient Health Questionnaire-9
Insomnia Severity Index
Late-Life Functional Disability Index
SF-12 Health Survey
Client Satisfaction Questionnaire
Brief RCOPE
Religious coping
Health services use
Use of psychotropic medication
Brief Multidimensional Measure of Religiousness and Spirituality
Satisfaction with Life Scale
Geriatric Depression Scale

Full Information

First Posted
October 4, 2012
Last Updated
January 11, 2016
Sponsor
Baylor College of Medicine
Collaborators
Retirement Research Foundation, Archstone Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT01702220
Brief Title
Calmer Life: Testing the Effectiveness of a Treatment for Anxiety
Official Title
Calmer Life: A Randomized Controlled Trial of a Participant-Centered Treatment for Anxiety in Low-Income, Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Retirement Research Foundation, Archstone Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall goals of the proposed research study are to: (1) examine quantitative outcomes in a well-conducted randomized clinical trial of Calmer Life, relative to Enhanced Community Care, an information and referral intervention that represents care in a real-world community-service environment, and (2) evaluate implementation feasibility, which includes training community providers; examining program reach, engagement, acceptability, and barriers-facilitators; and preparing practical tools for replicating the program.
Detailed Description
Cognitive behavioral treatment (CBT) produces positive outcomes for late-life worry/GAD in academic and primary care settings, but minorities are significantly underrepresented in clinical trials, and standard CBT poorly addresses the needs of low-income minority older adults in underserved communities. More attention needs to be given to service delivery of anxiety treatments for underserved older adults. Calmer Life (CL) is a culturally tailored, participant-centered research study that offers a skills-based intervention for late-life anxiety and includes other elements of care to meet the needs of underserved, minority older adults, including the option to integrate religion/spirituality (R/S), flexible delivery modes, and modular treatment format. Participants will be randomly assigned to CL or Enhanced Community Care(ECC). CL and ECC will be provided by behavioral health clinicians recruited from partner organizations, psychology trainees, and other research staff over 3 months. Assessments will occur at baseline and 3 months. Participants in the CL condition can choose up to 12 individual skill sessions, and will be recommended to complete a minimum of 6 sessions. If participants desire to incorporate R/S, an R/S assessment occurs during session 2 to help the provider understand the participant's beliefs and practices. R/S can be integrated into any of the skills learned during the intervention (e.g., deep breathing, self-statements, sleep management) or omitted entirely. Participants in the ECC condition will receive brief biweekly check in calls to provide information about community resources (including mental health), offer emotional support, and assess symptom severity and need for crisis intervention. Emergency procedures will be followed in crisis situations. After 3 months of ECC is completed, participants in the ECC group will be offered the CL intervention. Outcome measures will be administered for participants in both groups at baseline, 1 month, and 3 months. Participants in ECC will complete measures at 6 months after completion of CL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Anxiety Disorder NOS
Keywords
Generalized Anxiety Disorder, Geriatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT
Arm Type
Experimental
Arm Title
Enhanced Community Care (ECC)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
CBT
Other Intervention Name(s)
Cognitive Behavior Treatment, Cognitive Behavior Therapy
Intervention Description
6-12 sessions of CBT in person or over the phone
Intervention Type
Other
Intervention Name(s)
ECC
Other Intervention Name(s)
Enhanced Community Care
Intervention Description
6 biweekly sessions of ECC over the telephone
Primary Outcome Measure Information:
Title
Geriatric Anxiety Inventory
Time Frame
3 months
Title
Penn State Worry Questionnaire (PSWQ-A)
Time Frame
3 months
Title
Generalized Anxiety Disorder-7
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire-9
Time Frame
3 months
Title
Insomnia Severity Index
Time Frame
3 months
Title
Late-Life Functional Disability Index
Time Frame
3 months
Title
SF-12 Health Survey
Time Frame
3 months
Title
Client Satisfaction Questionnaire
Time Frame
3 months
Title
Brief RCOPE
Description
Religious coping
Time Frame
3 months
Title
Health services use
Time Frame
3 months
Title
Use of psychotropic medication
Time Frame
3 months
Title
Brief Multidimensional Measure of Religiousness and Spirituality
Time Frame
3 months
Title
Satisfaction with Life Scale
Time Frame
3 months
Title
Geriatric Depression Scale
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 50 and older Principal or Co-principal diagnosis of GAD or ADNOS Must speak English Must have a health care or social service provider and provide written authorization to research team to communicate with their health-care or social service provider Must live, work, worship, attend community functions, and/or receive health care in target geographic areas Exclusion Criteria: Active suicidal intent Current psychosis Mania or substance abuse within the last month Cognitive impairment according to a Mini Cog screener score of 3 or lower
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melinda A Stanley, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Center for Quality of Care and Utilization Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27426212
Citation
Stanley MA, Wilson N, Shrestha S, Amspoker AB, Armento M, Cummings JP, Evans-Hudnall G, Wagener P, Kunik ME. Calmer Life: A Culturally Tailored Intervention for Anxiety in Underserved Older Adults. Am J Geriatr Psychiatry. 2016 Aug;24(8):648-658. doi: 10.1016/j.jagp.2016.03.008. Epub 2016 Mar 29.
Results Reference
derived

Learn more about this trial

Calmer Life: Testing the Effectiveness of a Treatment for Anxiety

We'll reach out to this number within 24 hrs