Clinical trial NCT01702220: 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
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Anxiety Disorder NOS
Keywords: Generalized Anxiety Disorder
Geriatric
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Retirement Research Foundation
name: Archstone Foundation
First posted: 2012-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Geriatric Anxiety Inventory
timeFrame: 3 months
measure: Penn State Worry Questionnaire (PSWQ-A)
timeFrame: 3 months
measure: Generalized Anxiety Disorder-7
timeFrame: 3 months
Secondary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: 3 months
measure: Insomnia Severity Index
timeFrame: 3 months
measure: Late-Life Functional Disability Index
timeFrame: 3 months
measure: SF-12 Health Survey
timeFrame: 3 months
measure: Client Satisfaction Questionnaire
timeFrame: 3 months
measure: Brief RCOPE
timeFrame: 3 months
measure: Health services use
timeFrame: 3 months
measure: Use of psychotropic medication
timeFrame: 3 months
measure: Brief Multidimensional Measure of Religiousness and Spirituality
timeFrame: 3 months
measure: Satisfaction with Life Scale
timeFrame: 3 months
measure: Geriatric Depression Scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Center for Quality of Care and Utilization Studies
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Melinda A Stanley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.