INTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY

Int J Geriatr Psychiatry 2009; 24: 489499.

Published online 23 October 2008 in Wiley InterScience
(www.interscience.wiley.com) DOI: 10.1002/gps.2142

Effectiveness of a psychoeducational intervention program

in the reduction of caregiver burden in alzheimers disease
patients caregivers
Manuel Martn-Carrasco 1*, Manuel Franco Martn 2, Carmelo Pelegrn Valero 3,
Pedro Roy Millan 4, Celso Iglesias Garca 5, Salvador Ros Montalban 6,
Ana Luisa Gobartt Vazquez 7, Sonia Pons Piris 8 and Montserrat Balana Vilanova 7
1
Instituto de Investigaciones Psiquiatricas, Clnica Psiquiatrica Padre Menni. Pamplona, Spain
2
Complejo Hospitalario de Zamora, Zamora, Spain
3
Hospital Miguel Servet, Zaragoza, Spain
4
Clnica la Merce, Barcelona, Spain
5
CSM Fundacion Adaro, Asturias, Spain
6
Hospital del Mar, Barcelona, Spain
7
Medical Department, Novartis Farmaceutica, SA, Barcelona, Spain
8
Medical Department, Esteve, Barcelona, Spain

SUMMARY
Objectives Caregivers of patients with Alzheimers disease (AD) experience physical and psychological stress due to the
caring experience. This study evaluated the benefits of a Psychoeducational Intervention Program (PIP) on caregiver burden
in southern Europe.
Methods A multicentre, prospective, randomised study was conducted. One hundred and fifteen caregivers of patients with
clinical diagnosis of AD (DSM-IV-TR criteria, mini-mental score 1026) and functional impairment (Lawton and Brody
Scale and Katz Index) were recruited. Caregivers were randomised to receive either PIP (IG: intervention group, n 60) or
standard care (CG: control group, n 55). PIP consisted of eight individual sessions over 4 months for teaching strategies for
confronting problems of AD patient care. Caregivers stress, quality of life and perceived health were measured using
validated scales (Zarit, SF-36, GHQ-28, respectively) at baseline and after 4 and 10-months follow-up.
Results Mean change in caregiver burden (Zarit baselineZarit final scores) was statistically significant ( p 0.0083)
showing an improvement in the IG (
8.09 points) and a worsening in the CG (2.08 points). The IG showed significant
improvements in all the well-being perception areas measured by the SF-36 and a significantly lower score in the GHQ-28
( p 0.0004). 97.7% of caregivers and 88.6% of therapists considered PIP useful/very useful at 4 months (the end of PIP)
whereas at 10 months the estimates were 93.2% and 86.3%, respectively.
Conclusions Psychosocial training of caregivers can minimise caregiver distress and help them to develop problem-
solving strategies. A PIP improves quality of life and the perceived health of caregivers of patients with AD. Copyright #
2008 John Wiley & Sons, Ltd.

key words caregiver; burden; Alzheimers disease; psychoeducational program; southern Europe; dementia

INTRODUCTION nitive and functional deficits, psychiatric symptoms

Alzheimers Disease (AD) is a progressive neurode-
generative disorder, characterised clinically by cog-
*Correspondence to: Dr M. Martn-Carrasco, Clinica Psiquiatrica
Padre Menni, C/Joaquin Beunza, 45, 31014 Pamplona, Espana.
E-mail: mmartin@clinicapadremenni.org
Copyright # 2008 John Wiley & Sons, Ltd.
and behavioural disturbances. In the European Union,
it is estimated that 5.1 million people live with
dementia, close to half a million of them in Spain (Berr
et al., 2005). Over the next 50 years, this figure could
rise to 11.9 million.
Care and supervision increase in AD as the disease
progresses. The increasing dependence of sufferers
Received 5 February 2008
Accepted 3 September 2008
490 m. martn-carrasco
requires a significant effort from those closest to them,
since more than 70% of people with dementia live at
home, and virtually 75% of the necessary care is
provided by family and friends. It has been estimated
that the main carer of an AD patient can dedicate
around 70 hours per week to the task of caring (Boada
et al., 1999; Langa et al., 2001; Harrow et al., 2004).
Obviously, the efforts undertaken by the family carers
mean a substantial saving for the social and healthcare
services, but carers get in exchange a series of negative
consequences, collectively referred to as caregiver
burden (Donaldson and Burns, 1999).
The task of caring for a patient with AD affects
different aspects of the well-being of the carer
(physical and mental health, social and work
functioning, and finances). In addition, caregiver
burden also affects the patient, since carers with high
levels of burden are more likely to place the patients in
residential homes than less affected carers. Similarly,
patients whose carers experience less burden tend to
present a lower incidence of psychiatric symptoms,
such as delirium, depression and behavioural changes
(Dunkin and Anderson-Hanley, 1998; Torti et al.,
2004).
Thus, dealing with caregiver burden has become an
increasingly important aspect of therapeutic interven-
tion in AD. A whole series of interventions aimed at
reducing or preventing burden in dementia patient
caregivers have been developed. To date, the main
interventions have been: (a) formal support through
community services (e.g. day centres, etc.); (b) psycho-
educational programs; (c) mutual support groups;
(d) counselling; and (e) a combination of some of the
above. Unfortunately, scientific evidence to support
their efficacy remains limited, due mainly to the lack
of studies or because of limitations in their method-
ology (Cooke et al., 2001; Sorensen et al., 2002;
Brodaty et al., 2003; Selwood et al., 2007). However,
it is agreed that strictly informative interventions
and support groups have limited efficacy for
reducing caregiver burden, although they are regarded
important aids. Interventions focusing solely on
managing behavioural disorders have also been
unsuccessful.
The psychosocial interventions which have
received the greatest support are based on psycho-
educational models that cover a number of different
areas: information about the disease, organisation of
care, practical advice, skills training for the handling
of the behavioural problems of the patient, decision-
making, emotional repercussions on the caregiver, and
advice about self-care (Brodaty et al., 1997; Burns
et al., 2003; Teri et al., 2003; Mittelman et al., 2004).
Copyright # 2008 John Wiley & Sons, Ltd.
ET AL.
However, it must be stressed that the most successful
models of intervention are based on prolonged con-
tinuous support of the caregiveri.e. for years
while the majority of intervention techniques assessed
to date are of fixed duration and limited to a certain
number of sessions.
On the other hand, there is a lack of empirical
evidence to support the validity of those programs and
further studies with more scientific methodological
rigour are required (Gonzalez-Salvador et al., 1999;
Bedard et al., 2000; Gallagher-Thompson et al.,
2000). Standardisation of pharmacological treatment
with anti-dementia drugs (i.e. acetylcholinesterase
inhibitors, AChEIs) may be an important confounding
factor in former studies, since it has been suggested
that treatment with AChEIs may improve caregiver
burden, probably as a result of the improvement in the
psychiatric and behavioural disorders in the patients
(Fillit et al., 2000; Marin et al., 2003; Cummings
et al., 2004). Since there is a paucity of studies carried
out in southern Europe, and those that have been done
(Martin-Carrasco et al., 2002; Crespo et al., 2005;
Serrano-Aguilar et al., 2006; Gort et al., 2007) were
mainly epidemiological and did not evaluate inter-
ventions, it was decided to carry out this study with the
objective of evaluating the effectiveness of a
psychoeducational psychosocial intervention program
in the reduction of burden in caregivers of patients
with AD.
METHODS
Design
A multicentre, prospective, randomised study was
conducted in 11 hospital and non-hospital psychiatric
outpatient clinics across Spain. The primary objective
was to evaluate the efficacy of a structured psycho-
educational-type psychosocial intervention program
on caregiver burden in AD patients caregivers. The
study was approved by an Independent Ethics
Committee and its performance notified to the Spanish
Agency of Drugs and Sanitary products. Both patients
and caregivers were informed about the study and
respective signed consent was obtained.
Participants
Male and female unpaid caregivers, living in the
community, aged 18 or over, who lived with the
patient and dedicated a minimum of 4 hours a day to
directly caring for that patient were included.
Additionally, the caregivers had to present a baseline
Int J Geriatr Psychiatry 2009; 24: 489499.
DOI: 10.1002/gps
 psychoeducational intervention for reduction of caregiver burden in ad
score above 22 on the Zarit Scale (Zarit et al., 1980).
The patient had to be diagnosed with dementia due to
Alzheimers disease according to the DSM IV-TR
criteria (APA, 2000), have a Mini-Mental State
Examination (MMSE) (Lobo et al., 1999) score of
1026, with at least two instrumental activities
affectedas assessed with the Lawton and Brody
Scale (Lawton and Brody, 1969)or one basic
activity of daily livingassessed with the Katz Index
(Katz et al., 1963)and had to have been on
treatment with rivastigmine at a dose  6 mg/day for
a period of over 6 months. Caregivers who did not
have time to attend the sessions and those who were
receiving, or had received, any form of psychosocial
intervention specifically directed at alleviating the
burden in the previous year were excluded.
Intervention
Each study site had a principal investigatora
psychiatristand a therapist (clinical psychologist,
nurse or social worker). Each investigator had to
consecutively select and include 14 subjects from
among the caregivers of patients with AD in their care,
who were then referred to the therapist. The
randomised assignment was preformed by centre
and in blocks of four to the control group (CG) or to
the intervention group (IG). The CG of caregivers
received standard care (SC), consisting of: general
information about how AD progresses, individualised
information about the patient, both in person and over
the telephone on demand, information leaflets about
AD and information about resources directed at
caregivers available in their community. The IG
received the SC plus a Psychoeducational Intervention
Program (PIP), which consisted of eight individual 90-
min sessions, at 12-week intervals over 4 months. At
the sessions, information was provided about the
disease, but mainly, the caregivers were taught to
control tension and stress deriving from the caregiving
and also strategies for handling patients behavioural
problems and increasing their satisfaction with life.
Therefore, the program was not purely informative,
but incorporated elements of cognitive-behavioural
guidance, such as training in the control of activation,
cognitive restructuring techniques, problem solving
and increasing rewarding activities.
Specifically, the PIP was run as a skills training-
educational activity, which involved regularly and
periodically attending a course and included the
following objectives: (a) to help the caregiver control
tension and stress deriving from caregiving; (b) to
teach the caregiver different strategies for handling
Copyright # 2008 John Wiley & Sons, Ltd.
491
their relatives behavioural problems; and (c) to
increase their satisfaction with life. The PIP used was
based on the Palo Alto model, (Gallagher-Thompson
et al., 2000, 2003) and was adapted to our environment
by Instituto INGEMA (Etxebarria Arritxabal, 2005).
Investigators and therapists received a 10-hour
training course on how to run the PIP. The principal
investigator assessed the caregiver at each visit by
performing the self-rating scales (Zarit Scale, GHQ-
28 and SF-36) and recording resource consumption.
Evaluations
Three visits took place: a baseline visit (V1), a second
visit (V2) 4 months afterwards once the PIP had
finishedand a final visit (V3) 10 months after the
start of the study, (6 months after the end of the PIP).
At V1, the selection criteria were assessed, written
informed consent was obtained from the caregiver and
the patient, socio-demographic information was
collected from the caregiver and the patient, as well
as the primary and secondary endpoints (see below).
Patients clinical data were also recorded (MMSE,
Katz Index and Lawton and Brody Scale). At Visit
2 and Visit 3 measurements were done for the primary
and secondary endpoints and, in the IG, the caregiver
and the therapist made a subjective evaluation of the
usefulness of the PIP according to a five-point Likert
scale.
Completion of the PIP was assessed according to
attendance at the education/training sessions and was
considered satisfactory if it was above 70%, which
corresponded to a minimum of 6 of the 8 programmed
sessions.
Primary and secondary endpoints
The primary endpoint was the difference from
baseline in the level of caregiver burden before and
after the intervention, assessed using a Spanish
validated version of the Zarit Caregiver Burden
Interview. Secondary endpoints were Spanish vali-
dated versions of caregiver quality of life (SF-36
Health Survey Questionnaire; Alonso et al., 1995) and
caregiver mental health status (GHQ-28 General
Health Questionnaire; Lobo et al., 1986); the record
of the use of healthcare and social resources by the
caregiver and the patient; the analysis of the standard
care received by the caregiver, and, in the IG, the
evaluation of the PIP by the caregiver and therapist.
The Zarit Scale (Zarit et al., 1980) is a self-rating
scale with good reliability and validity (Martin
Carrasco et al., 1996; Gort et al., 2007), which has
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492 m. martn-carrasco
a range of scores from 22110, categorised into three
levels: absence of burden (2246 points), mild burden
(4755) and severe burden (56110). The SF-36 is a
self-rating scale with good estimates for reliability and
validity (Pukrop et al., 2003) which contains 36 items
grouped into eight sub-scales: physical functioning,
social functioning, role limitations due to physical
problems, role limitations due to emotional problems,
mental health, vitality, physical pain, and perception
of general health (Ware and Sherbourne, 1992). The
scores range from 0100; the higher the score, the
better the quality of life. The GHQ-28 (Goldberg and
Hillier, 1979) is considered as the gold standard of
questionnaires for the screening of psychiatric
disorders in the general population and in non-
psychiatric patients (de la Revilla et al., 2004). It
assesses four domains (Physical state, Mood, Activity,
Psychological state) and a cut-off score equal or larger
than 6 has been proposed for the detection of
psychiatric disorders. Resource consumption was
analysed by means of a semi-structured interview
which evaluated the description of external medical
care, both for patients and caregivers, taking into
account the number of events, the type of medical care
(primary care, specialist, social worker, others) and
the average time involved in each. A specifically
designed questionnaire was used to analyse the
components of the standard care received by the
caregiver.
STATISTICAL ANALYSIS
Sample size calculation
The PIP had to reflect a reduction in caregiver burden
on the Zarit Scale assuming a minimum mean
difference (effect) of 0.4 (Sorensen et al., 2002),
and a baseline score of 55 (SD 15) (Alonso et al.,
2004). Using these parameters, the required sample
size was of 100 caregivers per intervention group for
detecting differences of 6 points on the Zarit Scale
between the final values for the two groups (power of
85% and significance level of 0.05).
Statistical Analysis
For descriptive analysis, means, standard deviation,
maximum and minimum were used for the continuous
variables, and percentages and 95% Confidence
Intervals (95%CI) for the categorical variables. For
primary endpoint analysis, the difference for evaluable
caregivers between baseline and final scores for the
Zarit Scale was obtained for each study group. The
Copyright # 2008 John Wiley & Sons, Ltd.
ET AL.
comparison of their means was performed using an
ANOVA test. Additionally a comparison of raw means
among groups at each visit was performed using the
Wilcoxon test.
For secondary endpoint analyses the mean values
obtained for evaluable caregivers in the Zarit Scale,
SF-36 and GHQ-28 scores at each visit were compared
between the IG and the CG using the Wilcoxon test.
The percentages of patients with high probability of
presenting psychiatric disorders (GHQ > 5) in the IG
and the CG were compared using the Chi-square test.
RESULTS
Population
A total of 115 caregivers were recruited, 104 (90.4%)
of them completed the study. Of these, 11 (9.6%) did
not finish it: three (27.3%) due to voluntary with-
drawal; five (45.5%) due to lack of attendance; one
(9.1%) at the requirement of the investigator; and two
(18.2%) for other reasons. At baseline, there were no
statistically significant differences in the sociodemo-
graphic and clinical data between the intervention and
the control group (Table 1). 91.7% of the caregivers
attending all the PIP sessions.
Primary endpoint
Regarding the Zarit scale, the mean score reduction in
the intervention group was significantly larger than in
control group (ANOVA test, p 0.0083; Table 2 and
Figure 1). Additionally, at Visits 2 and 3, the
caregivers randomised to PIP had lower scores on
the Zarit Scale than those in the control group,
although these differences did not achieve statistical
significance (see Table 2). Nevertheless, a trend
towards a burden reduction and burden increase in
caregivers with and without PIP, respectively was
suggested by the fact that at the end of the study the
mean score on the Zarit Scale in the IC put them in the
category of mild burden, whereas those in the CG
continued at the level of severe burden.
Secondary endpoints
Regarding the SF-36 questionnaire, at the end of the
study, the IG had achieved mean scores significantly
higher than the CG in all the dimensions ( p < 0.05) but
mental health (see Table 3). Concerning the GHQ-28,
at Visit 2 the mean scores were lower in the IG than in
the CG, both for the total score and for the different
dimensions, with statistically significant differences
Int J Geriatr Psychiatry 2009; 24: 489499.
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 psychoeducational intervention for reduction of caregiver burden in ad 493

Table 1. Sociodemographic and baseline clinical data. Patients and caregivers

PATIENTS CAREGIVERS

WITH PIP WITHOUT PIP WITH PIP WITHOUT PIP

N 55 60 55 60
Gender, n (%)
Male 20 (36.4) 22 (36.7) 15 (27.3) 21 (35.0)
Female 35 (63.6) 38 (63.3) 40 (72.7) 39 (65.0)
Age (years)
Mean, (SD) 78.0(6.3) 76.7(6.1) 55(13.3) 61.6(13.8)
Usual medication for AD, n (%)
Rivastigmine 55(96.5) 60(89.6)
MMSE
Mean, (SD) 18.9(4.6) 18.6(5.03)
Lawton and Brody
Mean, (SD) 2.6(1.7) 2.18(1.6)
Katz Index, n (%) I D I D I D I D
Bathing 18 (30.0) 6 (10.0) 15 (27.3) 4 (7.3) 16 (26.7) 16 (26.7) 16 (29.1) 9 (16.4)
Dressing 29 (48.3) 2 (3.3) 20 (36.4) 1 (1.8) 24 (40.0) 4 (6.7) 16 (29.1) 3 (5.5)
Toileting 33 (55.0) 2 (3.3) 29 (52.7) 3 (5.5) 40 (66.7) 5 (8.3) 34 (61.8) 4 (7.3)
Transferring 34 (56.7) 1 (1.7) 32 (58.2) 1 (1.8) 48 (80.0) 1 (1.7) 44 (80.0) 3 (5.5)
Continence 28 (46.7) 0 26 (47.3) 0 39 (65.0) 1 (1.7) 31 (56.4) 1 (1.8)
Feeding 32 (53.3) 0 28 (50.9) 1 (1.8) 43 (71.7) 0 36 (65.5) 1 (1.8)
Marital status, n (%)
Single 7 (12.7) 9 (15)
Married 44 (80) 49 (81.7)
Separated, divorced 2 (3.6) 1 (1.7)
Widow/er 2 (3.6) 1 (1.7)
Work situation, n (%)
Working 11 (20) 18 (30)
Unemployed 3 (5.5) 4 (6.7)
Housewife 19 (34.5) 13 (21.7)
Retired 21 (38.2) 24 (40)
Disabled 1 (1.8) 1 (1.7)
Relationship to patient, n (%)
Spouse (partner) 29 (52.7) 34 (56.7)
Son/daughter 18 (32.7) 23 (38.3)
Son/daughter-in-law 2 (3.6) 1 (1.7)
Brother/sister 3 (5.5) 1 (1.7)
Other relative 1 (1.8) 1 (1.7)
Not related 2 (3.6) 0
Time since diagnosis (years)
Mean, (SD) 3.3(1.7) 2.9(2.03)
Time providing care (years)
Mean, (SD) 2.9(2.03) 3.2(2.6)
Hours dedicated/day
Mean, (SD) 12.6(7.6) 11.5(7.4)
Paid support worker, n (%)
No 48 (87.3) 48 (80.0)
Yes 7 (12.7) 12 (20.0)
Type of professional contracted, n (%)
Nurse 1 (14.3) 0 (0)
Auxiliary nurse 0 (0) 2 (16.7)
Home help 1 (14.3) 1 (1.7)
Others 5 (71.4) 1 (1.7)
Daily hours of worker contracted
< 1 h/day 0 (14.3) 2 (25.0)
13 h/day 0 (14.3) 1 (16.7)
48 h/day 3 (57.1) 5 (50.0)
920 h/day 0 (14.3) 0 (8.3)
Zarit
N 50 53
(Continues)

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494 m. martn-carrasco ET AL.

Table 1. (Continued)
PATIENTS CAREGIVERS

WITH PIP WITHOUT PIP WITH PIP WITHOUT PIP

Mean, (SD) 58.64(15.8) 61.42(15.83)

SF-36
N 53 57
Mean, (SD) 74.15(22.4) 77.75(23.56)
GHQ-28
N 54 58
Mean, (SD) 6.54(5.66) 8.57(7.51)
Use of resources
No, n (%) 24 (43.6) 29 (48.3) 39 (70.9) 41 (68.3)
Yes, n (%) 31 (56.4) 31 (51.7) 16 (29.1) 19 (31.7)

D Dependent; I Independent.

Table 2. Mean score of Zarit Scale. Evaluable caregivers

Zarit Scale Score CAREGIVER WITH PIP CAREGIVER WITHOUT PIP p-value
Wilcoxon ANOVA
N Mean SD N Mean SD

V1 44 62.0 14.9 38 58.4 15.9 0.3027

V2 44 56.6 16.4 37 58.3 16.7 0.5968
V3 44 54.0 15.9 38 60.5 16.6 0.0778
Change in score
Zarit (final) Zarit (baseline) 44
8.1 17.3 38 2.1 16.5 0.0083

V1 Baseline visit; V2 visit at 4 months; V3 final visit.

for the total scores and the Activity dimension
( p < 0.05). These differences were carried out to
Visit 3, where significantly lower scores were
observed in the IG than in the CG, both for the total
score and for each of the different dimensions of the
questionnaire ( p < 0.05) (Table 3 and Figure 2). Also
noted was a lower percentage of subjects with
Figure 1. Mean changes in Zarit score from baseline at end of
study.
psychiatric disorders (GHQ  5) in the IG than in
the CG at the end of the study period in all the
questionnaire dimensions, these differences reaching
statistical significance in the dimension of physical
health (2.3% and 18.4% for IG and CG, respectively;
Fishers exact test, p 0.0167; Odds Ratio (OR): 0.10,
CI: 0.010.88).
Regarding the use of resources, both in patients and
caregivers, the number of specialist and primary care
visits decreased in the IC group, whereas in the CG the
number of specialist visits decreased while there were
more primary care visits. The average time employed
in medical care for both patients and caregivers
gradually decreased in both groups over time. There
were no admissions to hospital (see Table 4). The
subjective evaluation of the usefulness of the PIP by
caregivers and therapists was generally positive,
considering the majority of the caregivers that
program was useful or very useful once the PIP
had finished (97.7%), and 6 months later (93.2%),
while 88.6% of the therapists considered it to be
useful or very useful once the PIP had finished and
86.3%, 6 months later.

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 psychoeducational intervention for reduction of caregiver burden in ad 495

Table 3. Mean scores of SF-36 and GHQ-28 health questionnaires. Evaluable caregivers

Score CAREGIVER WITH CAREGIVER WITH- p-(value) Wilcoxon t-test

PIP (n 44) OUT PIP (n 38)

Mean SD Mean SD

Quality of Life Questionnaire: SF-36

Physical Functioning at V1 74.3 25.5 71.7 21.4 0.3296
Physical Functioning at V3 80.1 20.7 68.8 25.6 0.0310
Physical Role at V1 61.4 44.6 53.9 44.5 0.3812
Physical Role at V3 84.7 34.6 56.8 47.0 0.0074
Bodily Pain at V1 63.0 25.9 61.4 26.2 0.9037
Bodily Pain at V3 74.0 18.7 61.7 26.9 0.0157
General Health at V1 48.4 18.5 44.6 19.2 0.4009
General Health at V3 53.4 18.0 40.1 15.7 0.0011
Vitality at V1 47.4 21.6 42.8 16.1 0.2925
Vitality at V3 53.8 15.9 38.9 17.9 0.0002
Social Functioning at V1 63.4 28.5 70.8 27.0 0.2175
Social Functioning at V3 71.0 23.4 58.9 27.7 0.0488
Emotional Role at V1 57.6 45.7 63.2 39.4 0.6596
Emotional Role at V3 73.5 41.0 47.4 48.2 0.0160
Mental Health at V1 60.2 9.5 60.8 8.1 0.7880
Mental Health at V3 63.0 9.2 60.9 8.3 0.3197
Psychiatric Health Questionnaire: GHQ-28
Total
V1 8.8 7.5 6.8 5.5 0.4080
V2 4.7 7.2 6.3 6.6 0.0340
V3 2.2 4.0 7.8 7.6 0.0004
Physical State (Dimension A)
V1 2.6 2.3 2.0 2.0 0.2893
V2 1.4 2.1 1.6 1.9 0.3588
V3 0.5 1.1 2.4 2.4 0.0001
Mood (Dimension B)
V1 3.0 2.5 2.5 2.1 0.4116
V2 1.5 2.3 2.2 2.4 0.1275
V3 1.0 1.7 2.4 2.4 0.0060
Activity (Dimension C)
V1 2.5 2.3 1.7 1.6 0.2453
V2 1.2 2.0 2.1 2.2 0.0211
V3 0.6 1.3 2.2 2.2 <0.0001
Psychological State (Dimension D)
V1 0.8 1.4 0.6 1.2 0.6762
V2 0.7 1.5 0.5 1.2 0.9900
V3 0.2 0.7 0.7 1.4 0.0270

V1 Baseline visit; V2 visit at 4 months; V3 final visit.

DISCUSSION the study sample correlate well with those found in

Our results support the efficacy of a psychoeduca-
tional intervention program in reducing the levels of
burden experienced by AD patient caregivers. The
results also support that the reduction in burden seems
to improve the quality of life in relation to health and
rates of psychiatric morbidity in this population. All of
them are negative aspects that have been typically
associated with burden in previous studies (Martin-
Carrasco et al., 1996; Ory et al., 1999; Martire and
Hall, 2002). The sociodemographic characteristics of
other studies in this field in Spain (Ministry of Work
and Social Affairs, 2005). That fact combined with the
multicentric nature of the study, allows us to suppose
that our results may be generally applicable to the
population of caregivers of patients with dementia in
Spain.
Our study has also established that the positive
effects of the intervention continue to last beyond the
duration of the program, at least for a further 6 months.
This is an important issue to assess the efficacy of this
type of interventions, because of caregiving typically

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496 m. martn-carrasco ET AL.

carries on for several years. It would seem probable

Figure 2. Evolution of psychiatric health. Mean GHQ-28 score in
the intervention and control groups (total score). p 0.0340 at visit
2; Wilcoxon test; p 0.0004 at FINAL visit, Wilcoxon test.
that a complex intervention with a psychoeducational
program could lead to a series of changes in the way
the caregiver tackles the problems associated with
caregiving, making it easier to cope with its intense
demands.
Our results agree with those obtained in similar
studies (Ostwald et al., 1999; Marriott et al., 2000;
Hepburn et al., 2001; Gitlin et al., 2003), although
differences in methodology, and especially differences
in the intervention programs, do not allow for a direct
comparison of results (Lopez and Crespo, 2007). In
addition, other researchers have reported negative
(Brodaty et al., 1994) or inconclusive results
(Quayhagen et al., 2000).

Table 4. Description of the use of resources. Evaluable patients and carergivers

Patients

Description of the care V1 V2

WITHOUT PIP With PIP Without PIP With PIP

Number of visits n, % N % N % N % N %
0 16 42.1 22 50.0 25 65.8 29 65.9
1 18 47.4 13 29.5 9 23.7 10 22.7
2 2 5.3 6 13.6 4 10.5 3 6.8
3 or > 2 5.2 3 6.8 0 0 0 0
Total 38 100.0 44 100.0 38 100.0 44 100.0
Type of medical care n, % N % N % N % N %
Primary Care 16 50 16 45.7 11 64.7 10 37
Specialist 16 50 18 51.4 6 35.3 8 29.6
Social Worker 0 0 0 0 0 0 1 3.7
Others 0 0 1 2.9 0 0 8 29.6
TOTAL 32 100 35 100.0 17 100.0 27 100.0
Time spent on medical care (minutes)
Mean, (SD) 44.6 (36.7) 64.43 (147.6) 21.8 (11.0) 28.5 (25.5)
Caregiver

Description of the care V1 V2

Without PIP With PIP Without PIP With PIP

Number of visits n, % N % N % N % N %
0 27 71.1 29 65.9 29 76.3 34 77.3
1 6 15.8 11 25 8 21.1 8 18.2
2 2 5.3 2 4.5 1 2.6 2 4.5
3 or > 3 7.8 2 4.5 0 0 0 0
Total 38 100 44 100 38 100 44 100
Type of medical care n, % N % N % N % N %
Primary Care 14 58.3 16 76.2 9 90 8 66.7
Specialist 8 33.3 5 23.8 1 10 2 16.7
Social Worker 0 0 0 0 0 0 1 8.3
Others 2 8.3 0 0 0 0 1 8.3
Total 24 100 21 100 10 100 12 100
Time spent on medical care (minutes) N % N % N % N %
Mean, (SD) 54.6 (48.3) 32.1 (37.8) 14.5 (10.1) 24.6 (19.6)
V1 baseline visit; V2 visit at 4 months.

Copyright # 2008 John Wiley & Sons, Ltd. Int J Geriatr Psychiatry 2009; 24: 489499.
DOI: 10.1002/gps
 psychoeducational intervention for reduction of caregiver burden in ad
A feature of this study worth highlighting is that it
was carried out in mental health centres by an
interdisciplinary mental health team (psychiatrists,
nurses, psychologists and social workers). We believe
that this study reinforces the importance of the
involvement of mental health services in the provision
of care for dementia, in accordance with the
indications of the Spanish Dementia Consensus
(Spanish Society of Psychiatry and Spanish Society
of Psychogeriatry, 2005) and other european Guide-
lines (Waldemar et al., 2007). This study also supports
the inclusion of psychoeducational programs as part of
standard care for relatives of patients with AD and
probably also with other types of dementia.
The main limitation of the study was the difficulty
in recruiting the total sample estimated at the
beginning of the trial. The final sample size was
approximately 50% of the theoretically estimated. As
a result, the post-hoc power calculation was of 75%,
compared with the power of 85% initially estimated in
the protocol. Despite that drawback our study has been
able to show statistically significant differences for the
primary endpoint of the study and for the majority of
the secondary endpoints.
KEY POINTS
 A multicentre, prospective, randomised study
evaluated the benefits of a Psychoeducational
Intervention Program (PIP) on burden of 115
AD patients caregivers.
 The PIP consisted of eight individual 90-min
sessions, at 12-week intervals over 4 months
and was not purely informative, but incorporated
elements of cognitive-behavioural guidance.
 The results support the efficacy of a psycho-
educational intervention program in reducing
the levels of burden, improving the quality of life
in relation to health and rates of psychiatric
morbidity in this population.
CONFLICT OF INTEREST
Dr Martin-Carrasco acting as a consultant, receiving
grants, or being hired as a speaker by the following
companies: Novartis, Pfizer, Lilly, Janssen-Cilag,
Wyeth, Andromaco, Lundbeck, GSK, Sanofi-Aventis
and Bristol-Myers Squibb. Dr Franco acting as a
consultant, receiving grants, or being hired as a
speaker by the following companies: Novartis,
Copyright # 2008 John Wiley & Sons, Ltd.
497
Bristol-Myers, Pfizer. He has also acted as a consultant
and has received grants from the Intras Foundation,
European Union. Dr Pelegrin has no potential conflict
of interest relevant to this manuscript. Dr Roy being
hired as a speaker for Lundbeck, Farma-Lepori, and
receiving grants from Eisai. Dr Igliesias acting as a
consultant, received grants, or being hired as a speaker
by the following companies: Wyeth, Boeringuer
Ingelheim, Lilly, Bristol Myers Squibb. He has also
acted as a consultant and has received grants from the
Fundacion Benito Jeronimo Feijoo. Dr Ros acting as a
consultant, receiving grants, or being hired as a
speaker by Janssen-Cilag, Lilly, Esteve, Boehringer,
AstraZeneca, Almirall, Lundbeck, Glaxo Smith Kline,
Organon, Whyeth, Pfizer, Bristol Myers Squibb,
Otsuka, Novartis, Servier. He has also acted as
consultant and has received grants from the Institut d
Investigacions Mediques, IMIM. Dr Pons being an
employee for Esteve. Dr Gobartt and Mrs Balana
being employees for Novartis Farmaceutica, S.A. No
other potential conflicts of interest relevant to this
article were reported.
ACKNOWLEDGEMENTS
This study was supported by an unrestricted grant
from Novartis (Spain) and Esteve.
We thank the following investigators for their
participation in the study: Jesus Ruiz (Clnica La
Merce-Barcelona); Pilar Otermin (Hospital General
de Granollers); Joaqun Pujol (Hospital Clnic-Barce-
lona); Francisco Caro, Alfonso Perez (Hospital
Miguel Server-Zaragoza); Marcos Huerta (CSM Fun-
dacion Adaro-Asturias); Luis Aguera (CMS Argan-
zuela-Madrid); M Jesus Martn (Clnica
Mediterranea de Neurociencias-Alicante). We also
thank Marta Mas (Trial Form Support) and Javier
Ballesteros (Instituto de Investigaciones Psiquiatricas)
for assistance with manuscript preparation and data
analysis.
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