Reducing CVD Risk in Caregivers: A Brief Behavioral Activation Intervention

NCT ID: NCT01802554

Last Updated: 2016-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2013-02-28

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.

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.

Conditions

Depressive Symptoms; Inflammation

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Pleasant Events Program (PEP)

Intervention Type: BEHAVIORAL

Behavioral Activation Therapy

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.

Group Type: ACTIVE_COMPARATOR

Information Support (IS)

Intervention Type: BEHAVIORAL

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

Interventions

Pleasant Events Program (PEP)

Behavioral Activation Therapy

Intervention Type: BEHAVIORAL

Information Support (IS)

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Brent Mausbach

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brent Mausbach, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California San Diego

La Jolla, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22888824 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22486550 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22224706 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22149759 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21600868 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21429282 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21312008 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21292054 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21130981 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23290198 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23916631 (View on PubMed)

Other Identifiers

R01AG031090

Identifier Type: NIH

Identifier Source: org_study_id

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