Calmer Life: Testing the Effectiveness of a Treatment for Anxiety

Generalized Anxiety Disorder Clinical Trial

Official title:

Calmer Life: A Randomized Controlled Trial of a Participant-Centered Treatment for Anxiety in Low-Income, Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01702220
• Other study ID #: H30928
• Status: Completed
• Phase: N/A
• First received: October 4, 2012
• Last updated: January 11, 2016
• Start date: October 2012
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorder NOS
• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder

Intervention

Behavioral:
• CBT
6-12 sessions of CBT in person or over the phone

Other:
• ECC
6 biweekly sessions of ECC over the telephone

Locations

Country	Name	City	State
United States	Houston Center for Quality of Care and Utilization Studies	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Baylor College of Medicine	Archstone Foundation, Retirement Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geriatric Anxiety Inventory		3 months	No
Primary	Penn State Worry Questionnaire (PSWQ-A)		3 months	No
Primary	Generalized Anxiety Disorder-7		3 months	No
Secondary	Patient Health Questionnaire-9		3 months	No
Secondary	Insomnia Severity Index		3 months	No
Secondary	Late-Life Functional Disability Index		3 months	No
Secondary	SF-12 Health Survey		3 months	No
Secondary	Client Satisfaction Questionnaire		3 months	No
Secondary	Brief RCOPE	Religious coping	3 months	No
Secondary	Health services use		3 months	No
Secondary	Use of psychotropic medication		3 months	No
Secondary	Brief Multidimensional Measure of Religiousness and Spirituality		3 months	No
Secondary	Satisfaction with Life Scale		3 months	No
Secondary	Geriatric Depression Scale		3 months	No