Skip to content

Calmer Life: Testing the Effectiveness of a Treatment for Anxiety

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01702220
Enrollment
60
Registered
2012-10-08
Start date
2012-10-31
Completion date
2015-08-31
Last updated
2016-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder, Anxiety Disorder NOS

Keywords

Generalized Anxiety Disorder, Geriatric

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.

Interventions

BEHAVIORALCBT

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

OTHERECC

6 biweekly sessions of ECC over the telephone

Sponsors

Retirement Research Foundation
CollaboratorOTHER
Archstone Foundation
CollaboratorOTHER
Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Geriatric Anxiety Inventory3 months
Penn State Worry Questionnaire (PSWQ-A)3 months
Generalized Anxiety Disorder-73 months

Secondary

MeasureTime frameDescription
Patient Health Questionnaire-93 months
Insomnia Severity Index3 months
Late-Life Functional Disability Index3 months
SF-12 Health Survey3 months
Health services use3 months
Brief Multidimensional Measure of Religiousness and Spirituality3 months
Satisfaction with Life Scale3 months
Geriatric Depression Scale3 months
Client Satisfaction Questionnaire3 months
Use of psychotropic medication3 months
Brief RCOPE3 monthsReligious coping

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026