Clinical trial NCT02391363: Calmer Life: Treating Worry Among Older Adults In Underserved, Low-income, Minority Communities
Official title: Calmer Life: Treating Worry Among Older Adults In Underserved, Low-income, Minority Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: anxiety
worry
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-03-18
Enrollment: 247
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 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.

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

Primary outcomes:
measure: Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months
timeFrame: Baseline, 6 months
measure: Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months
timeFrame: Baseline, 9 months
measure: Generalized Anxiety Disorder-7 (GAD-7) at 6 Months
timeFrame: Baseline, 6 months
measure: Generalized Anxiety Disorder-7 (GAD-7) at 9 Months
timeFrame: Baseline, 9 months
Secondary outcomes:
measure: Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months
timeFrame: Baseline, 6 months
measure: Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months
timeFrame: Baseline, 9 months
measure: Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months
timeFrame: Baseline, 6 months
measure: Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months
timeFrame: Baseline, 9 months
measure: Geriatric Depression Scale Short Form (GDS) at 6 Months
timeFrame: Baseline, 6 months
measure: Geriatric Depression Scale Short Form (GDS) at 9 Months
timeFrame: Baseline, 9 months
measure: Insomnia Severity Index (ISI) at 6 Months
timeFrame: Baseline, 6 months
measure: Insomnia Severity Index (ISI) at 9 Months
timeFrame: Baseline, 9 months
measure: Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months
timeFrame: Baseline, 6 months
measure: Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months
timeFrame: Baseline, 9 months
measure: Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months
timeFrame: Baseline, 6 months
measure: Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation
timeFrame: Baseline, 9 months
measure: Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months
timeFrame: Baseline, 6 months
measure: Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS)
timeFrame: Baseline, 9 months
measure: Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months
timeFrame: Baseline, 6 months
measure: Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months
timeFrame: Baseline, 9 months
measure: PTSD Checklist-5 (PCL-5) Total at 6 Months
timeFrame: Baseline, 6 months
measure: PTSD Checklist-5 (PCL-5) Total at 9 Months
timeFrame: Baseline, 9 months
measure: Health Service Use at 6 Months
timeFrame: Baseline, 6 months
measure: Health Service Use at 9 Months
timeFrame: Baseline, 9 months
measure: Hospital Admissions at 6 Months
timeFrame: Baseline, 6 months
measure: Hospital Admissions at 9 Months
timeFrame: Baseline, 9 months
measure: Social Service or Resource Use at 6 Months
timeFrame: Baseline, 6 months
measure: Social Service or Resource Use at 9 Months
timeFrame: Baseline, 9 months
measure: Psychological Service Use at 6 Months
timeFrame: Baseline, 6 months
measure: Psychological Service Use at 9 Months
timeFrame: Baseline, 9 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: VA HSR&D Center for Innovations in Quality, Effectiveness & Safety (IQuESt)
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Melinda A Stanley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.