Department of Psychiatry, Wythenshawe Hospital, Manchester
Department of Psychiatry, Manchester Royal Infirmary, Manchester
Department of Psychiatry, Wythenshawe Hospital, Manchester
Department of Medical Statistics, Wythenshawe Hospital, Manchester
Department of Psychiatry, Wythenshawe Hospital, Manchester, UK
Correspondence: Professor Alistair Burns, Department of Psychiatry, 2nd Floor, Education and Research Centre, Wythenshawe Hospital, Southmoor Road, Manchester M23 9LT, UK. Tel: +44 (0)161 291 5887; fax: +44 (0)161 291 5882; e-mail: Alistair.Burns{at}manchester.ac.uk
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ABSTRACT |
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Aims The aim was to assess, in a randomised controlled trial, whether psychotherapeutic intervention could benefit cognitive function, affective symptoms and global well-being.
Method Individuals were randomised to receive six sessions of psychodynamic interpersonal therapy or treatment as usual; cognitive function, activities of daily living, a global measure of change, and carer stress and coping were assessed prior to and after the intervention.
Results No improvement was found on the majority of outcome measures. There was a suggestion that therapy had improved the carers' reactions to some of the symptoms.
Conclusions There is no evidence to support the widespread introduction of brief psychotherapeutic approaches for those with Alzheimer's disease. However, the technique was acceptable and helpful individually.
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INTRODUCTION |
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The aim of this study was to assess, in a randomised controlled trial, whether a psychotherapeutic approach directed towards individuals with Alzheimer's disease could benefit cognitive function, affective symptoms and global well-being.
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METHOD |
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Following consent, individuals were allocated to one of two groups - treatment or control - using computer-generated random numbers organised independently by the Department of Medical Statistics in South Manchester. Those allocated to the control group could elect to have the therapeutic sessions after the study. All assessments and therapeutic interventions were conducted in the individuals' own homes. Those taking anticholinesterase drugs for the treatment of Alzheimer's disease or other psychotropic medication (such as antidepressants) had to be clinically stable on these medications for at least 2 months prior to study entry.
Therapeutic interventions
Those in the treatment group received six sessions of psychodynamic
interpersonal therapy with an experienced psychotherapist. Those in the
control group received standard care, which consisted of general advice
regarding the diagnosis and treatment of dementia, with out-patient
review.
Psychodynamic interpersonal therapy
Psychodynamic interpersonal therapy was formerly known as the
conversational model of psychotherapy
(Hobson, 1985) and has been
used to treat a wide variety of disorders including depression
(Shapiro & Firth, 1987;
Shapiro et al, 1993), somatisation
(Guthrie et al, 1991;
Hamilton et al, 2000)
and self-harm (Guthrie et al,
2001). The principal aim of the therapy (in its brief format) is
the identification of interpersonal conflicts or difficulties, which are
causing or helping to maintain emotional distress. Client and therapist work
together to find and test solutions to these problems, and both intrapsychic
and practical changes are encouraged.
Adaptation of the technique
The therapy was adapted for people with Alzheimer's disease. Full details
are available elsewhere (Brierley et
al, 2003). The main adaptations included delivery in the
individual's home and involving the carer in the treatment. Four specific
psychological areas were targeted. Autobiographical narrative was used to
strengthen self-worth. Important past conflicts, which resonated with current
difficulties, were explored and resolved. The illness itself was discussed and
emphasis placed on improving social and interpersonal relationships including,
but not emphasising, the role of the partner. In addition to the individual
therapy, the therapist spent 10 min each session with the carer, listening to
the carer's needs and informing the carer of therapeutic progress.
Implementation of the technique
Psychotherapy sessions lasted 50 min. The psychotherapy has been summarised
in a manual (Shapiro & Firth,
1987) and treatment fidelity was ensured by regular supervision
using audiotapes. One session from each individual therapy was rated for
adherence to the model using the Sheffield Psychotherapy Rating Scale
(Shapiro & Startup, 1993).
This scale allows sessions to be rated according to three main subscales: one
for psychodynamic interpersonal therapy; one for cognitive-behavioural
therapy; and one for generic aspects of psychotherapy. The intervention showed
high scores on the psychodynamic interpersonal therapy and generic sub-scales
and low scores on the cognitive-behavioural therapy scale, confirming
adherence to the model.
Assessments of patients
The following assessments were carried out before the start of the therapy,
at the end of the therapy (6 weeks after recruitment) and at 3 months
follow-up.
Cornell Scale for Depression in Dementia
This is a 19-item scale assessing depressive symptoms in people with
dementia (Alexopoulos et al,
1988). It is rated on a three-point scale of absent, mild or
intermittent, and severe. A score of 8 or above is indicative of significant
depressive symptoms.
Mini-Mental State Examination
This is a 30-item measure of cognitive function, with a maximum score of 30
points (Folstein et al,
1975). It normally takes 5-10 min to complete.
Revised Memory and Behavior Problems Checklist
This is a 24-item questionnaire rating both the frequency of behavioural
problems in those with dementia and the intensity of the reactions in their
carers (Teri et al,
1992). Frequency and reaction are both rated on a six-point
scale.
Bristol Activities of Daily Living Scale
This is a 20-item questionnaire, rated by the carer in 10-15 min
(Bucks et al, 1996).
Twenty areas of daily activities are each rated on a five-point scale from no
problem to severe problems.
Assessments of carers
General Health Questionnaire
This is a 12-item self-report questionnaire to assess psychological
distress and psychiatric morbidity
(Goldberg & Williams,
1985). It is completed in 5 min or less and each item is rated on
a four-point scale.
Beck Depression Inventory
This is a 21-item self-report questionnaire to assess depression in the
respondent (Beck et al,
1961). It normally takes 10-20 min to complete. Each item is
scored from 0 to 3 and a total score is derived. A total score of 12 or more
suggests the presence of depression.
Ways of Coping Checklist
This is a 42-item self-report questionnaire to assess the carer's coping
strategies (Vitaliano et al,
1985). It normally takes 15-20 min to complete and is rated on a
four-point scale, from not applicable to very much used.
Global assessment
Clinician's Interview-Based Global Impression of Change
This is a seven-point scale used by the researcher and an external
supervisor to detect change in the patients at 6-week and 3-month follow-up
(Guy, 1976). The scale goes
from very much improved to very much worse. The rating was completed following
a discussion between the research assistant (F.M.-F.) and the senior clinician
(A.B.), who was masked to group membership (treatment or control).
The 20 individuals who took part in the treatment arm of the study completed a satisfaction survey. Four statements were presented and the patients were asked to reply.
Statistical analysis, randomisation and calculation of sample size
All analyses used the intention-to-treat principle. The effect of
intervention was assessed by comparing changes in mean scores over time on
continuous variables using analyses of covariance, with baseline scores and
age as covariants. Some scores required a natural logarithmic transformation
prior to analysis to produce a satisfactory approximation to a normal
distribution. For these scores, geometric means (detransformed log means) are
presented rather than simple arithmetic means. Chi-squared tests, where
appropriate, were performed on categorical measures.
There are no current data upon which to base a power calculation. In our previous study (Marriott et al, 2000), group sizes of 14 were sufficient to detect a statistically significant difference. Based on these data, we allowed for a withdrawal rate of 20%, and chose to recruit 20 individuals in each group. Part of the rationale for this pilot study was to obtain some normative data on which to calculate a sample size for a definitive study.
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RESULTS |
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Table 1 describes the study groups and main results from the assessments. There were 20 people recruited to each group. Most commonly it was the spouse who cared for the patient; 25% of the treatment group and 15% of the control group were on antidepressants, and approximately two-thirds of each group were on one of the anticholinesterase drugs for Alzheimer's disease. All participants completed the study and follow-up.
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There were no significant differences over the course of the study in the outcome measures for the patients, including ratings on the Cornell Scale, Mini-Mental State Examination and Activities of Daily Living Scale, or in the global rating for the outcome measures for the carers. There were no changes over the course of the study in the General Health Questionnaire or Beck Depression Inventory. There was a trend towards a slight improvement in the carer's reaction to behavioural problems. Section 2 of the Ways of Coping Checklist showed a significant decline (P <0.05); this section rates the carer's interaction with other people as an aid to coping.
There was no difference in the ratings when the patients were divided into two groups by Mini-Mental State Examination score (above or below 24). However, there was some evidence that carers of those with less cognitive impairment (score above 24) benefited more from the treatment in that they blamed themselves less for the problems (section 3 of the Ways of Coping Checklist at 3 months, mean value 0.14 compared with 0.35, P=0.031).
Qualitative assessments
Every participant agreed with the statement I was able to discuss my
difficulties with my counsellor and became more clear about what they
are. Eighty-three per cent agreed with the following three statements:
I find doing things I can do and not thinking too much about what I
cannot do, helps me feel less frustrated; Although it sometimes
felt painful talking about my past, it felt good to get things off my chest,
and I felt calm; and I have been able to talk about some things
that have been difficult to talk to anyone else about.
Some of the positive comments from patients included:
Comments from the carers included:
The 20 participants who received therapy were visited between 6 and 12 months after recruitment. A semi-structured open-ended interview was carried out. Five of the patients had some recollection of the sessions, and all five confirmed that they had found it helpful.
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DISCUSSION |
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The therapist was clearly a major source of support for the carers and the patients.
Rationale for the trial
We chose to target an area that has received relatively little attention in
Alzheimer's disease. Traditional therapies have tended to be pharmacological
in nature, targeting either cognitive or non-cognitive symptoms
(Tariot, 1999).
Non-pharmacological interventions, aside from some behavioural techniques
(Allen-Burge et al,
1999), have concentrated on carers, and psychological approaches
are of proven benefit in reducing carer strain
(Marriott et al,
2000). As far as we are aware, this is the first randomised
controlled trial of a psychotherapeutic intervention in people with
Alzheimer's disease using standardised outcome measures. The psychotherapeutic
approach was determined following a pilot study and adapted to the individual
needs of the participants, as the model dictates. The joint sessions with the
participants and carers merely helped the therapist to focus on those symptoms
that were considered important and distressing.
Reasons for non-response
The finding that the intervention had no effect on measures that reflect
the core features of the illness (cognitive function, activities of daily
living) is not surprising. Only six sessions were provided which, in
psychotherapeutic terms, is a low-dose treatment, and this may partly explain
the lack of effect. In addition, a longer study would be needed to assess the
more likely benefits in terms of stabilisation of disease. The beneficial
effect on carers is indicated by the scores on the Ways of Coping Checklist,
which showed that the therapy helped carers by providing someone to talk to
and, for those caring for people with mild dementia, diminished the carers'
sense of self-blame. There was minimal involvement of the carers in the
therapy. A beneficial effect on patients themselves can be inferred from the
improvement in the global rating of well-being.
It is not surprising that the involvement of the therapist appeared to have a positive impact and is in accordance with other experience in the field. What is important is that the therapy can be adapted for use in people with cognitive impairment.
The trend towards improvements in both carer and patient outcomes attests to the potential benefit of non-pharmacological interventions in this group. Future studies in this area should concentrate specifically on approaches that combine outcomes of carers and those in their care. The interdependency of the aspirations and outcomes of people with Alzheimer's disease and their carers is emphasised by this project and will influence future studies in this area.
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Clinical Implications and Limitations |
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LIMITATIONS
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ACKNOWLEDGMENTS |
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Received for publication June 15, 2004. Revision received October 25, 2004. Accepted for publication November 5, 2004.
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