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A Three-Country Randomized Controlled Trial of a Psychosocial Intervention for Caregivers Combined With Pharmacological Treatment for Patients With Alzheimer Disease: Effects on Caregiver Depression

https://doi.org/10.1097/JGP.0b013e3181898095Get rights and content

Objective

To evaluate the effectiveness of a combination of cholinesterase inhibitor therapy for patients with Alzheimer disease (AD) and psychosocial intervention, for their spouse caregivers compared with drug treatment alone in three countries simultaneously.

Design

Randomized controlled trial. Structured questionnaires were administered at baseline and at regular follow-up intervals for 24 months by independent raters blind to group assignment.

Setting

Outpatient research clinics in New York City, U.S., Manchester, U.K. and Sydney, Australia.

Participants

Volunteer sample of 158 spouse caregivers of community dwelling patients with AD.

Interventions

Five sessions of individual and family counseling within 3 months of enrollment and continuous availability of ad hoc telephone counseling were provided for half the caregivers. Donepezil was prescribed for all patients.

Main Outcome Measure

Depressive symptoms of spouse caregivers measured at intake and follow-up assessments for 24 months using Beck Depression Inventory (revised).

Results

Depression scores of caregivers who received counseling decreased over time, whereas the depression scores for caregivers who did not receive counseling increased. The benefit of the psychosocial intervention was significant after controlling for site, gender and country was not accounted for by antidepressant use and increased over 2 years even though the individual and family counseling sessions occurred in the first 3 months.

Conclusion

Effective counseling and support interventions can reduce symptoms of depression in caregivers when patients are taking donepezil. Harmonized multinational psychosocial interventions are feasible. Combined drug and supportive care approaches to the management of people with AD should be a priority.

Section snippets

Study Subjects

To be eligible, patients were required to meet National Institute of Neurological and Communicative Disorders and Stroke–AD and Related Disorders Association and Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for probable AD22, 23; have a Global Deterioration Scale (GDS)24 score of 4 to 5, indicating mild to moderate dementia at enrollment; have no contra-indication to donepezil; be stable with other medications; be in good general physical health; be able to

Demographic Characteristics of Subjects, Subject Accrual, and Follow-Up

Demographic details for patient and caregivers are provided in Table 1. Nearly all patients had mild to moderately severe dementia (GDS 4 or 5). (We inadvertently included two patients in the treatment group and one in the control group with GDS 6 ratings and three patients in the control group with GDS 3 ratings.) Subjects did not differ significantly in caregiver gender or age, patient age or severity of patient dementia between countries, or treatment groups.

Table 2 shows the number of

DISCUSSION

In this study, the first to examine the combined effects of a caregiver intervention and pharmacotherapy, we demonstrated that five sessions of counseling based on the NYU model40 reduced depression scores in spouses of persons with AD taking donepezil. This benefit was significant in analyses that controlled statistically for caregiver gender and country and was not accounted for by antidepressant use.

Although the difference in change in depressive symptoms between the two groups was small, it

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    The authors thank the caregivers and patients for their participation, the NYU-ADC counselors in New York, Sean Page and Jane Winter in Manchester, and Angi Lesmina, Karen Berman, and Lynn Seifman in Sydney, Australia.

    This work was supported by an unrestricted grant from Pfizer, Inc. Additional resources were provided by the NYU Alzheimer's Disease Center P30 AG08051.

    ClinicalTrials.gov registration number NCT00467766.

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