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Completed

NCT Number: NCT01702220

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houston Center for Quality of Care and Utilization Studies

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT

Behavioral

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

Other names: Cognitive Behavior Treatment, Cognitive Behavior Therapy

ECC

Other

6 biweekly sessions of ECC over the telephone

Other names: Enhanced Community Care

Primary outcomes

  1. Geriatric Anxiety Inventory

    Time frame: 3 months

  2. Penn State Worry Questionnaire (PSWQ-A)

    Time frame: 3 months

  3. Generalized Anxiety Disorder-7

    Time frame: 3 months

Secondary outcomes

  1. Patient Health Questionnaire-9

    Time frame: 3 months

  2. Insomnia Severity Index

    Time frame: 3 months

  3. Late-Life Functional Disability Index

    Time frame: 3 months

  4. SF-12 Health Survey

    Time frame: 3 months

  5. Client Satisfaction Questionnaire

    Time frame: 3 months

  6. Brief RCOPE

    Time frame: 3 months

    Religious coping

  7. Health services use

    Time frame: 3 months

  8. Use of psychotropic medication

    Time frame: 3 months

  9. Brief Multidimensional Measure of Religiousness and Spirituality

    Time frame: 3 months

  10. Satisfaction with Life Scale

    Time frame: 3 months

  11. Geriatric Depression Scale

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Archstone Foundation
  • Retirement Research Foundation

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 8, 2012
Registry last updated
Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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