Reducing CVD Risk in Caregivers: A Brief Behavioral Activation Intervention
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|ClinicalTrials.gov Identifier: NCT01802554|
Recruitment Status : Completed
First Posted : March 1, 2013
Results First Posted : April 3, 2014
Last Update Posted : June 13, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Depressive Symptoms Inflammation||Behavioral: Pleasant Events Program (PEP) Behavioral: Information Support (IS)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Reducing CVD Risk in Caregivers: A Brief Behavioral Activation Intervention|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
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 Information-Support (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. Each IS session allowed caregivers to select issue(s) from the resource manual to discuss. The therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided.
Behavioral: Information Support (IS)
Information-Support (IS) condition consisted of supportive psychotherapy and informational brochures.
- Brief Center for Epidemiologic Studies Depression Scale (CESD) [ Time Frame: Change from Baseline CESD at 8-weeks ]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 ]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 ]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.
- Positive and Negative Affect Schedule [ Time Frame: Change from Baseline Positive Affect at 8-weeks ]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 ]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.
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|Ages Eligible for Study:||55 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802554
|United States, California|
|University of California San Diego|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Brent Mausbach, PhD||University of California, San Diego|
|Responsible Party:||Brent Mausbach, Associate Professor, University of California, San Diego|
|Other Study ID Numbers:||
R01AG031090 ( U.S. NIH Grant/Contract )
|First Posted:||March 1, 2013 Key Record Dates|
|Results First Posted:||April 3, 2014|
|Last Update Posted:||June 13, 2016|
|Last Verified:||May 2016|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|