Reducing CVD Risk in Caregivers: A Brief Behavioral Activation Intervention

NCT01802554 | Completed Results DMC

• 1 other identifier: R01AG031090
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depressive Symptoms; Inflammation

Keywords

Behavioral Activation; Caregiver; Dementia; Cardiovascular Disease; Alzheimer's Disease; Coagulation

Outcome Measures

Primary Outcomes (3)

• Brief Center for Epidemiologic Studies Depression Scale (CESD)

  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.

  Change from Baseline CESD at 8-weeks

• D-dimer

  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.

  Change from Baseline D-dimer at 8-weeks

• Interleukin-6 (IL-6)

  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.

  Change from Baseline IL-6 at 8-weeks

Secondary Outcomes (2)

• Positive and Negative Affect Schedule

  Change from Baseline Positive Affect at 8-weeks

• Positive and Negative Affect Schedule

  Change from Baseline Negative Affect at 8-weeks

Study Arms (2)

Pleasant Events Program (PEP)

EXPERIMENTAL

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)

Information-Support (IS)

ACTIVE COMPARATOR

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)

Interventions

Pleasant Events Program (PEP) BEHAVIORAL

Behavioral Activation Therapy

Pleasant Events Program (PEP)

Information Support (IS) BEHAVIORAL

Information-Support (IS) condition consisted of supportive psychotherapy and informational brochures.

Information-Support (IS)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

Location

Related Publications (11)

• Chattillion EA, Ceglowski J, Roepke SK, von Kanel R, Losada A, Mills PJ, Romero-Moreno R, Grant I, Patterson TL, Mausbach BT. Pleasant events, activity restriction, and blood pressure in dementia caregivers. Health Psychol. 2013 Jul;32(7):793-801. doi: 10.1037/a0029412. Epub 2012 Aug 13.

  PMID: 22888824 BACKGROUND

• Mausbach BT, Chattillion E, Roepke SK, Ziegler MG, Milic M, von Kanel R, Dimsdale JE, Mills PJ, Patterson TL, Allison MA, Ancoli-Israel S, Grant I. A longitudinal analysis of the relations among stress, depressive symptoms, leisure satisfaction, and endothelial function in caregivers. Health Psychol. 2012 Jul;31(4):433-40. doi: 10.1037/a0027783. Epub 2012 Apr 9.

  PMID: 22486550 BACKGROUND

• Mausbach BT, Roepke SK, Chattillion EA, Harmell AL, Moore R, Romero-Moreno R, Bowie CR, Grant I. Multiple mediators of the relations between caregiving stress and depressive symptoms. Aging Ment Health. 2012;16(1):27-38. doi: 10.1080/13607863.2011.615738.

  PMID: 22224706 BACKGROUND

• Chattillion EA, Mausbach BT, Roepke SK, von Kanel R, Mills PJ, Dimsdale JE, Allison M, Ziegler MG, Patterson TL, Ancoli-Israel S, Grant I. Leisure activities, caregiving demands and catecholamine levels in dementia caregivers. Psychol Health. 2012;27(10):1134-49. doi: 10.1080/08870446.2011.637559. Epub 2011 Dec 12.

  PMID: 22149759 BACKGROUND

• Mausbach BT, Chattillion EA, Moore RC, Roepke SK, Depp CA, Roesch S. Activity restriction and depression in medical patients and their caregivers: a meta-analysis. Clin Psychol Rev. 2011 Aug;31(6):900-8. doi: 10.1016/j.cpr.2011.04.004. Epub 2011 Apr 28.

  PMID: 21600868 BACKGROUND

• Moore RC, Harmell AL, Chattillion E, Ancoli-Israel S, Grant I, Mausbach BT. PEAR model and sleep outcomes in dementia caregivers: influence of activity restriction and pleasant events on sleep disturbances. Int Psychogeriatr. 2011 Nov;23(9):1462-9. doi: 10.1017/S1041610211000512. Epub 2011 Mar 24.

  PMID: 21429282 BACKGROUND

• Harmell AL, Chattillion EA, Roepke SK, Mausbach BT. A review of the psychobiology of dementia caregiving: a focus on resilience factors. Curr Psychiatry Rep. 2011 Jun;13(3):219-24. doi: 10.1007/s11920-011-0187-1.

  PMID: 21312008 BACKGROUND

• Mausbach BT, Roepke SK, Depp CA, Moore R, Patterson TL, Grant I. Integration of the pleasant events and activity restriction models: development and validation of a "PEAR" model of negative outcomes in Alzheimer's caregivers. Behav Ther. 2011 Mar;42(1):78-88. doi: 10.1016/j.beth.2009.11.006. Epub 2010 Oct 15.

  PMID: 21292054 BACKGROUND

• Mausbach BT, Harmell AL, Moore RC, Chattillion EA. Influence of caregiver burden on the association between daily fluctuations in pleasant activities and mood: A daily diary analysis. Behav Res Ther. 2011 Jan;49(1):74-9. doi: 10.1016/j.brat.2010.11.004. Epub 2010 Nov 22.

  PMID: 21130981 BACKGROUND

• Mausbach BT, Chattillion EA, Roepke SK, Patterson TL, Grant I. A comparison of psychosocial outcomes in elderly Alzheimer caregivers and noncaregivers. Am J Geriatr Psychiatry. 2013 Jan;21(1):5-13. doi: 10.1016/j.jagp.2012.10.001. Epub 2013 Jan 2.

  PMID: 23290198 BACKGROUND

• Moore RC, Chattillion EA, Ceglowski J, Ho J, von Kanel R, Mills PJ, Ziegler MG, Patterson TL, Grant I, Mausbach BT. A randomized clinical trial of Behavioral Activation (BA) therapy for improving psychological and physical health in dementia caregivers: results of the Pleasant Events Program (PEP). Behav Res Ther. 2013 Oct;51(10):623-32. doi: 10.1016/j.brat.2013.07.005. Epub 2013 Jul 19.

  PMID: 23916631 RESULT

MeSH Terms

Conditions

Depression; Inflammation; Dementia; Cardiovascular Diseases; Alzheimer Disease; Thrombosis

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Embolism and Thrombosis; Vascular Diseases

Results Point of Contact

• Title: Brent T Mausbach, PhD
• Organization: University of California San Diego

BMausbach@ucsd.edu

858-822-7529

Study Officials

• Brent Mausbach, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: March 1, 2013
• Study Start: April 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: June 13, 2016
• Results First Posted: April 3, 2014

Record last verified: 2016-05

Locations

US (1)