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Calmer Life: Treating Worry Among Older Adults In Underserved, Low-income, Minority Communities

Baylor College of Medicine logo

Baylor College of Medicine

Status

Completed

Conditions

Anxiety

Treatments

Behavioral: Information and referral
Behavioral: Cognitive behavior treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02391363
AD-1310-06824

Details and patient eligibility

About

The purpose of this research study is to see how helpful two different interventions offered through the Calmer Life program are in reducing worry and improving mood. The investigators also want to understand how a program like Calmer Life can be offered in underserved communities.

Full description

Background: Recurrent, excessive, uncontrollable worry about multiple topics is common in older adults, but it is not well studied. This significant worry can negatively affect thinking, and it is associated with poorer sleep, more depression, and worse general health. Despite its prevalence, researchers have not studied significant worry enough, particularly in low-income racial and ethnic minority populations. We know these groups are unlikely to have adequate mental health care. We also know that older adults and minorities prefer treatments for worry that do not require medication, and that these kinds of treatments can be effective. Additional tests of treatments that do not involve drugs are needed in low-income racial and ethnic minority populations. Such person-centered research could expand access to appropriate care.

Objectives: The study team plans to compare two approaches, one called Calmer Life (CL) and another called Enhanced Community Care (ECC). CL helps individuals by providing worry-reduction skills and resource counseling for basic needs in a flexible, culturally supportive manner. ECC relies on standard information and resource counseling. The study will answer three questions. First, compared to ECC, is CL more effective at relieving significant worry? Second, which one is more effective at reducing anxiety and depression and improving sleep, ability to do daily activities, and use of medical services? Third, are improvements still present three months after treatment concludes?

Methods: In agreement with our community partners and governed by a council of community leaders, consumers, and providers from low-income minority communities, we will conduct the study. This community-academic partnership, created four years ago, introduced CL to the community. Case managers and community health workers from partner organizations were trained to implement CL. They taught worry-reduction skills and helped participants increase their use of community resources. Content was flexible so that participants could choose which skills to learn and whether or not to include religion or spirituality. They also could learn skills at home, by telephone, or in the community. In a new, larger comparison study, we will enroll 120 women and 30 men who are 50 years of age or older with significant worry. Most (80 percent) will be African American, and 70 percent will have income below poverty. Participants will be assigned by chance to CL or ECC and treated for six months. Brief assessments at enrollment and at six and nine months will rely on participants' reports. Differences will be measured statistically.

Enrollment

247 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • PSWQ greater than 22

Exclusion criteria

  • PHQ score less than 20
  • Active suicidal intent
  • Active psychosis or bipolar disorder
  • Substance abuse
  • Cognitive impairment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

247 participants in 2 patient groups

Calmer Life
Experimental group
Description:
Cognitive behavior treatment for anxiety
Treatment:
Behavioral: Cognitive behavior treatment
Enhanced Community Care
Active Comparator group
Description:
Enhanced information and referral services for mental health and basic needs
Treatment:
Behavioral: Information and referral

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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