Calmer Life: Testing the Effectiveness of a Treatment for Anxiety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Generalized Anxiety Disorder Anxiety Disorder NOS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CBT

Group Type EXPERIMENTAL

CBT

Intervention Type BEHAVIORAL

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

Enhanced Community Care (ECC)

Group Type ACTIVE_COMPARATOR

ECC

Intervention Type OTHER

6 biweekly sessions of ECC over the telephone

Interventions

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CBT

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

Intervention Type BEHAVIORAL

ECC

6 biweekly sessions of ECC over the telephone

Intervention Type OTHER

Other Intervention Names

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Cognitive Behavior Treatment, Cognitive Behavior Therapy Enhanced Community Care

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No