Reducing CVD Risk in Caregivers: A Brief Behavioral Activation Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brent Mausbach, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01802554
First received: February 20, 2013
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

Cardiovascular disease and depression are some of the most costly illnesses to society, and caring for a loved-one with Alzheimer's disease has been associated with increased risk for both depression and cardiovascular disease. Indeed, depressive symptoms have been linked with elevated plasma concentrations of D-dimer and Interleukin-6 (IL-6), both of which are associated with increased risk for cardiovascular disease (CVD). The present research tests a brief behavioral intervention for reducing both depressive symptoms and CVD biomarkers in Alzheimer caregivers. We hypothesize that caregivers receiving a brief Behavioral Activation (BA) therapy will show greater reductions in depressive symptoms and in CVD biomarkers relative to those randomized to a time-equivalent Information and Support (IS) therapy.


Condition Intervention
Depressive Symptoms
Inflammation
Behavioral: Pleasant Events Program (PEP)
Behavioral: Information Support (IS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing CVD Risk in Caregivers: A Brief Behavioral Activation Intervention

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Brief Center for Epidemiologic Studies Depression Scale (CESD) [ Time Frame: Change from Baseline CESD at 8-weeks ] [ Designated as safety issue: No ]
    The Brief CESD is a measure of depressive symptoms. The scale's minimum score is 0 and maximum score is 30. Lower scores represent fewer depressive symptoms and thus better outcomes.

  • D-dimer [ Time Frame: Change from Baseline D-dimer at 8-weeks ] [ Designated as safety issue: No ]
    D-dimer is an indicator of fibrin formation and its subsequent lysis and is a useful biomarker representing overall activation of blood coagulation. High concentrations of D-dimer have been linked prospectively to onset of Coronary Heart Disease. Blood was collected by a research nurse in the caregivers' homes through a 22 gauge forearm catheter after a 20 minute rest. Blood for D-dimer was dispensed into polypropylene tubes with 3.8 percent sodium citrate and spun at 1600 g for 10 minutes at room temperature. Obtained plasma was stored at minus 80 degrees Celsius until analyzed. Plasma D-dimer (Asserachrom Stago, Asnieres, France) was determined via high sensitive enzyme-linked immunosorbent assays. Intra- and interassay coefficients of variation were less than 5 percent.

  • Interleukin-6 (IL-6) [ Time Frame: Change from Baseline IL-6 at 8-weeks ] [ Designated as safety issue: No ]
    IL-6 is one of many biomarkers represented in the inflammatory cascade which is initiated during an immune response. Prospectively, increased plasma IL-6 is also associated with future myocardial infarction in healthy men and increasing concentrations of IL-6 have been associated with both nonfatal myocardial infarction and fatal Coronary Heart Disease (CHD) in longitudinal studies of population-based cohorts. Higher concentrations of IL-6 raise CHD risk. Blood was collected by a research nurse in the caregivers' homes through a 22-gauge forearm catheter after a 20 min rest. Blood for IL-6 was dispensed in Ethylenediaminetetraacetic acid (EDTA) tubes and spun at 3000 g for 10 minutes at 4 to 8 degrees Celsius. Obtained plasma was stored at minus 80 degrees Celsius until analyzed. Plasma IL-6 (Meso Scale Discovery, Gaithersburg, MD) was determined via highsensitive enzyme-linked immunosorbent assays. Intra- and interassay coefficients of variation were less than 5 percent.


Secondary Outcome Measures:
  • Positive and Negative Affect Schedule [ Time Frame: Change from Baseline Positive Affect at 8-weeks ] [ Designated as safety issue: No ]
    This scales contains ten items assessing Positive Affect. Items included are adjectives, such as "interested," "strong," and "inspired". Participants rated each adjective based on how they felt over the past few weeks using a 5-point scale with responses ranging from 1 (very slightly to not at all) to 5 (extremely). The scale's minimum score is 10 and maximum score is 50. Higher scores represent better outcomes.

  • Positive and Negative Affect Schedule [ Time Frame: Change from Baseline Negative Affect at 8-weeks ] [ Designated as safety issue: No ]
    This scales contains ten items assessing Negative Affect. Items included are adjectives, such as "distressed," "ashamed," and Participants rated each adjective based on how they felt over the past few weeks using a 5-point scale with responses ranging from 1 (very slightly to not at all) to 5 (extremely). The scale's minimum score is 10 and maximum score is 50. Lower scores represent better outcomes.


Enrollment: 100
Study Start Date: April 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pleasant Events Program (PEP)
The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.
Behavioral: Pleasant Events Program (PEP)
Behavioral Activation Therapy
Active Comparator: Information-Support (IS)
Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided.
Behavioral: Information Support (IS)
Supportive Psychotherapy and informational brochures

Detailed Description:

Due to an aging society, the number of people diagnosed with dementia is expected to increase dramatically over the next two decades, with a concomitant rise in the number of family members providing informal care for their loved ones. The stresses associated with this care have been well-documented in the scientific literature, and are noted to be associated with increased risk for psychological and physical morbidity, particularly cardiovascular disease. Indeed, caregiving is associated with elevations in negative affect (e.g., depressive and anxiety symptoms), which in turn is associated with biological indicators that are thought to predict CVD risk (e.g., markers of coagulation and inflammation). The primary goal of this study is to examine the efficacy of a brief Behavioral Activation (BA) Treatment, called the Pleasant Events Program (PEP), for reducing biological CVD risk indicators in a sample of Alzheimer caregivers. We will enroll 100 dementia caregivers and randomly assign them to receive 4-sessions of PEP or 4-sessions of support + information. Our PEP intervention will be conducted in caregivers' homes and will emphasize the importance of monitoring and increasing activities that help individuals make contact with natural reinforcers in their environments, identifying and reducing negative coping responses, and selection and achievement of behavioral goals for healthier living. Caregivers will be assessed for our biological outcomes at baseline, post-treatment, and 1-year to determine intervention efficacy. Given the brief nature of the PEP intervention, the ease with which it can be applied in real-world settings (e.g., community agencies providing services to caregivers), and lack of difficult skills for interventionists and caregivers to acquire, we believe our PEP intervention will be easily transferred to "real-world" settings. If our PEP intervention is efficacious, it may have a considerable impact on both the physical and mental health of caregivers, and will likely have public health implications.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 55 or older and providing at-home care for a care recipient (CR) with a physician-diagnosis of Alzheimer's disease (AD) or related dementia.

Exclusion Criteria:

  • Receiving beta-blocking medications at enrollment
  • Receiving treatment with Anticoagulant medications
  • Severe hypertension (>200/120 mmHg)
  • Diagnosed with a terminal illness with a life expectancy <6 months
  • Enrolled in another intervention study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802554

Locations
United States, California
University of California San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Brent Mausbach, PhD University of California, San Diego
  More Information

Publications:

Responsible Party: Brent Mausbach, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01802554     History of Changes
Other Study ID Numbers: R01AG031090
Study First Received: February 20, 2013
Results First Received: December 10, 2013
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Behavioral Activation
Caregiver
Dementia
Cardiovascular Disease
Alzheimer's Disease
Coagulation

Additional relevant MeSH terms:
Inflammation
Depression
Pathologic Processes
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 26, 2014