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

NCT ID: NCT02391363

Last Updated: 2019-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 247 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-02-28

Brief Summary

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.

Detailed 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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Calmer Life

Cognitive behavior treatment for anxiety

Group Type: EXPERIMENTAL

Cognitive behavior treatment

Intervention Type: BEHAVIORAL

Anxiety management skills with the option to included religious/spiritual beliefs and practices

Enhanced Community Care

Enhanced information and referral services for mental health and basic needs

Group Type: ACTIVE_COMPARATOR

Information and referral

Intervention Type: BEHAVIORAL

Resource counseling and follow-up for mental health and basic needs

Interventions

Cognitive behavior treatment

Anxiety management skills with the option to included religious/spiritual beliefs and practices

Intervention Type: BEHAVIORAL

Information and referral

Resource counseling and follow-up for mental health and basic needs

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Melinda Stanley

Professor and Head, Division of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melinda A Stanley, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

VA HSR&D Center for Innovations in Quality, Effectiveness & Safety (IQuESt)

Houston, Texas, United States

Countries

United States

References

Stanley MA, Wilson NL, Shrestha S, Amspoker AB, Wagener P, Bavineau J, Turner M, Fletcher TL, Freshour J, Kraus-Schuman C, Kunik ME. Community-Based Outreach and Treatment for Underserved Older Adults With Clinically Significant Worry: A Randomized Controlled Trial. Am J Geriatr Psychiatry. 2018 Nov;26(11):1147-1162. doi: 10.1016/j.jagp.2018.07.011. Epub 2018 Aug 7.

Reference Type: DERIVED

PMID: 30224269 (View on PubMed)

Steiner AJ, Boulos N, Wright SM, Mirocha J, Smith K, Lopez E, Gohar SH, Ishak WW. Major Depressive Disorder in Patients With Doctoral Degrees: Patient-reported Depressive Symptom Severity, Functioning, and Quality of Life Before and After Initial Treatment in the STAR*D Study. J Psychiatr Pract. 2017 Sep;23(5):328-341. doi: 10.1097/PRA.0000000000000251.

Reference Type: DERIVED

PMID: 28961662 (View on PubMed)

Shrestha S, Wilson N, Kunik ME, Wagener P, Amspoker AB, Barrera T, Freshour J, Kraus-Schuman C, Bavineau J, Turner M, Stanley MA. Calmer Life: A Hybrid Effectiveness-implementation Trial for Late-life Anxiety Conducted in Low-income, Mental Health-Underserved Communities. J Psychiatr Pract. 2017 May;23(3):180-190. doi: 10.1097/PRA.0000000000000234.

Reference Type: DERIVED

PMID: 28492456 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AD-1310-06824

Identifier Type: -

Identifier Source: org_study_id