Calmer Life: Testing the Effectiveness of a Treatment for Anxiety
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Calmer Life: A Randomized Controlled Trial of a Participant-Centered Treatment for Anxiety in Low-Income, Older Adults|
- Geriatric Anxiety Inventory [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Penn State Worry Questionnaire (PSWQ-A) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Generalized Anxiety Disorder-7 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Patient Health Questionnaire-9 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Insomnia Severity Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Late-Life Functional Disability Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- SF-12 Health Survey [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Client Satisfaction Questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Brief RCOPE [ Time Frame: 3 months ] [ Designated as safety issue: No ]Religious coping
- Health services use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Use of psychotropic medication [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Brief Multidimensional Measure of Religiousness and Spirituality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Satisfaction with Life Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Geriatric Depression Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||August 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
6-12 sessions of CBT in person or over the phone
Other Name: Cognitive Behavior Treatment, Cognitive Behavior Therapy
|Active Comparator: Enhanced Community Care (ECC)||
6 biweekly sessions of ECC over the telephone
Other Name: Enhanced Community Care
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702220
|United States, Texas|
|Houston Center for Quality of Care and Utilization Studies|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Melinda A Stanley, PhD||Baylor College of Medicine|