For many clinicians and researchers
schizophrenia is still regarded as a chronic illness with persistent,
recurrent and debilitating symptoms with no expectations of sustained
remission or functional recovery. However both retrospective and
prospective studies reveal that the course of schizophrenia is not a
uniform process, and may be altered by or benefit from integrated and
continuous treatments. An increasing amount of empirical studies
informed that recovery from schizophrenia is possible under two
conditions: at onset, with an integrated approach and rational use of
medication and in those cases of greater severity or with frequent
relapses, using treatments that combine biological, psychological and
social strategies, applied continuously in the form of coordinated
services (Lenrrot et al, 2003).
One of the most significant areas over the past decades for the
treatment of schizophrenic psychosis has been intervention in the
family setting. Almost thirty controlled studies have revealed that
family psycho-educational methods enhance relatives’ capacity to cope
with problems and improve family atmosphere, reduce the risk of relapse
(Pharoah & Steiner, 2003) and hospital readmission, increase
therapeutic compliance and reduce relatives’ burden (Sellwood et al,
2003). The findings in this field generally suggest that
relatives who support a person with schizophrenia with reasonable
expectations for their improvement and with aids focused on achieving
gradual progress may be a critical factor in the long-term outcome
(Falloon I, 2004).
Experience gained in recent years indicates that beneficial effects are
greater in initial episodes and in those cases of most recent onset (
Mauser et al, 2001). Despite initial treatment is usually intensive a
fall in the overall economic cost of care has been observed (Chisholm
et al, 2005).
A study of initial episodes shows that integrated treatment not only
proved to be effective, but was also more beneficial for patients than
standard treatment, with significant clinical implications (Petersen et
al 2007). Following decades of research the time has come to put these
interventions into practice (Torrey, et al 2001). However the transfer
of beneficial effects detected in experimental studies to clinical
practice is a challenge for the mental health services. Not only is
there a need for a sufficient number of appropriately well trained
professionals but also continuity of care delivery. Both aspects are
the foundations on which to base the effectiveness of any
scientifically compared psychosocial intervention (Tornicroft &
Susser, 2001).
To the best of our knowledge there is no information available
regarding the outcomes arising from the discontinuation of an effective
integrated treatment. This is particularly significant when the
majority of programmes and studies published in the literature have
been conducted within the framework of a research project. At the end
of the study the experience gained has not been incorporated into the
routine practice of mental health services.
The implementation of an integrated treatment for people with
schizophrenia and their families was unexpectedly discontinued due to
lack of institutional support. This provided an opportunity to study
the impact on the clinical and social state of the patient and his or
her support group.
Material and Method
It is a simple follow-up study of people with schizophrenia and their
families who received integrated treatment in the clinical practice
setting. The study design makes it possible to show the clinical and
social benefits linked to therapy intervention outside the experimental
setting as well as effects linked to the interruption of the treatment
twelve months later.
The intervention was offered to people diagnosed with schizophrenia
(DSM IV R) attended by the mental health team from a mental health
center in Valencia (Spain). A minimum duration of 2 yrs of intervention
was estimated and was geared towards patients with a history of the
illness of no more than 5 yrs who presented psychotic relapse or a
first episode in the past 12 months. All participants understood what
the procedure involved and gave their informed consent.
No other selection procedure was applied, neither depending on level of
family Expressed Emotion (EE), severity of symptoms or ethnicity,
except for insufficient language skills for following the sessions. The
subjects were able to drop-out in the event of side effects, if it was
considered to be in his/her best interests or if he/she decided not to
continue.
Therapy Intervention
The main objective of the integrated treatment was to reduce
deficiencies and discapacities as much as possible and achieving the
best recovery level. It follows community psychiatric care guidelines,
provides integrated care involving therapy shown to be effective with
scientific evidence, is delivered by a multi-disciplinary team,
guarantees the continuity of treatment, focuses on the person and their
relatives’ needs, offers carers a well defined role and is of a
flexible and ambulatory nature (Table1).
The intervention was conducted by a team of specifically trained
professionals in each of the therapeutic strategies to be implemented,
followed by supervised sessions. The therapeutic sessions, each lasting
one hour, were held in the patient’s home, initially on a weekly basis
and subsequently less frequent.
All patients and their families were informed that the intervention was
to be discontinued and spent the final session reviewing achievements,
constructive changes and work carried out and preparing for treatment
to be continued in a different context. Likewise, the families were put
into contact with the local Family Association. (AFEM)
Assessment
In order to present recovery patterns or otherwise, a series of
clinical, social and family evaluations were carried out as well as use
of resources at three different points in time: at the start of the
intervention , at the end and one year later.
The instruments used are based on those previously employed in the
international multi-centre project with the object of making results
easier to compare.( Falloon et al, 2004)10
Clinical state was appraised using the Mental Functions Impairment
Scale MFIS (Guy W) This measure focuses on evaluating the amount of
daily time that psychotic symptoms are present, independent of the
degree of discapacity and level of distress that psychotic experiences
may produce. The Disability Index, ID (Roser & Kind) was applied to
assess the overall degree of disability and social maladjustment. In
order to assess level of family perceived stress, a semi-structured
scale was used Carer’s Stress Scale (Falloon). Relapses were defined
according to clinical criteria: “significant increase in psychotic
symptoms requiring greater clinical measures for their control” and
readmissions as the “number of hospital admissions associated with
mental disorders”.
The information was extracted by two evaluators independent of the
treatment team with clinical experience and prior training in the
administration and measurement of the different instruments.
Statistical Analysis
Multiple and repeated measurements were used for comparing changes in
the clinical, social and family stress outcomes, at the three
evaluation points (0= pre-treatment, 1= post-treatment, 2= follow-up).
This analysis of these differences was carried out with the Student t
for related samples and variance analysis (Anova) for multiple
comparisons.
Results
A total of 15 patients (10 men and 5 women) and their families took
part in the programme until it was discontinued. Average age was 23.47
(ds 2.85) and except for one patient who was separated, the rest were
single and all lived with their family, with the majority (66.7%)
unemployed. The age of onset of first symptoms was 21 years with a
range of 19 to 28 and the average history of illness was 2 years (range
1 to 4 years) and almost half (46.6%) had previously been hospitalised.
In the initial evaluation all people who have schizophrenia showed
productive psychotic symptoms, with severity and intensity index placed
at 3.13 (ds1.4). Likewise discapacity index was 2.72 (ds 0.79),
indicating a moderate level of discapacity. Stress level reported by
relatives was between moderate and high, reaching average scores of
(2.47 ds 0.74).
As the entrance to the programme was dynamic the number of sessions
differs between cases, ranging from 24 sessions in those who joined the
programme early on, to just six sessions in the last case to join.
One patient decided to drop-out of the intervention after the first
three sessions, stating that no improvement had been noted, leaving a
final sample of 14 cases.
At the point of discontinuation all indices analyzed had improved as
compared to the start. No relapses or worsening of psychosis and only
one hospital admission took place, a decision taken in agreement with
the patient in order to undergo treatment for cocaine-addiction. During
the intervention process no adverse effect was detected that could be
linked to the intervention itself.
A year after discontinuation, all the main results had worsened,
although none of the outcomes reached the mean scores of the starting
point of the 14 patients followed up. Five people (35.7%) relapsed
after discontinuation of the intervention with one requiring hospital
admission. A metabolic syndrome was detected in one case, there was an
increase of substance misuse, 42.8% of the cases dropped out of
anti-psychotic maintenance treatment and 28.5% of the ambulatory
regime. (Table 2)
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Table 2.- Means
and percentages of clinical, discapacity
and family stress scores at three points in time.
>
|
|
Pre-intervent (n=15)
|
Post-intervent
(n=14)
|
Follow-up
(n=14)
|
|
Clinical index ( means,ds)
|
3,13 (1,41)
|
1.57 (1.519
|
2.93 (2,13)
|
|
Discapacity index (means,ds)
|
2,73 (0.79)
|
1,64 (1,49)
|
2,43(1.45)
|
|
Family stress(means,ds)
|
2,47 (6,60)
|
0,93 (1,07)
|
1,57 (1,28)
|
|
Relapses (n, %)
|
---
|
0 (0%)
|
5 (35,7%)
|
|
Hospital admissions (n,%)
|
6 (40,6)
|
1 (6,6)
|
4 (28,6)
|
|
Non-adherence to medication
(n,%)
|
1 (6,60)
|
0 (0)
|
6 (42,8)
|
|
Substance misuse (n,%)
|
2 (13,3)
|
1 (7,14)
|
3 (21,4)
|
Table
3 shows the analysis’ results of changes in clinical status,
discapacity and family stress at the three points in time, where a
clearly negative impact in the three results can be observed. By
comparing the differences in changes between follow-up, that is a year
after discontinuation of the intervention, with those detected at the
start of the treatment scores are similar to those detected at the
start. One exception was family stress level that fell significantly
during the intervention, increased after the end of the intervention,
and subsequently fell again (t=2.065, p= 0.059).
Table
3. Results of the
analysis of the differences in changes brought about at three points of
evaluation
|
|
|
Mean
|
sd
|
CI
95 %
|
t
|
Follow-up
|
|
Clinical
Severity
|
Pret-post
|
1.50
|
1.69
|
(0.52
- 2.48)
|
3.30
|
0.006
|
|
Post-follow
|
-1.38
|
1.86
|
(-2.43)-(-0.28)
|
-2.73
|
0.017
|
|
Pre-follow
|
0.14
|
2.53
|
(-1.32)-(1.61)
|
0.21
|
0.836
|
|
Discapacity
|
Pret-post
|
1.07
|
1.82
|
(0.02
- 2.12)
|
2.21
|
0.046
|
|
Post-follow
|
-0.78
|
1.53
|
(-1.66)-(0.09)
|
0.69
|
0.077
|
|
Pre-follow
|
2.86
|
1.54
|
(-0.64)-(1.17)
|
-1.17
|
0.500
|
|
Family
stress
|
Pret-post
|
1.43
|
1.02
|
(0.84
- 2.01)
|
5.26
|
0.000
|
|
Post-follow
|
-0.64
|
1.45
|
(-1.47)-(0.19)
|
-1.66
|
0.120
|
|
Pre-follow
|
0.79
|
1.42
|
(-0.04)-(1.61)
|
2.06
|
0.059
|
Pre-post=
start - time of discontinuation
Post-follow=
discontinuation - one year later
Pre-follow=
start - one year after discontinuation
No correlation has been observed between the number of sessions and the
therapy response on ending the intervention nor in follow-up, which
could be explained by the small size of the sample along with lower
frequency of the sessions. However, unlike the case of anti-psychotics
and anti-depressants, where both therapeutic responses as well as side
effects are related to dose, the dose-response relationship of
psychosocial interventions is less well known
Discussion
As in all naturalistic studies the greatest shortcoming is being able
to attribute the changes to the effect of the treatment or in this case
to its unexpected discontinuation. However, the inclusion of a control
group would currently pose problems of an ethical nature and the
possibility of including a control group consisting of a waiting list
would imply logistical problems regarding duration of the project.
Concerning the use of equivalent historic cohorts there are too many
uncontrolled variables to be able to establish valid comparisons.
Despite the small number of cases where significant differences were
not detected in some analyses, the results in general point in the same
direction: loss of benefits gained during the integrated treatment as
compared to the year following discontinuation of the programme. The
levels of clinical and social deterioration reached were very similar
to those detected at the start of the intervention.
Family stress shows a tendency to fall rapidly after the first sessions
increasing after discontinuation but with lower scores than before
starting the intervention. It is possible that information received and
the feeling of being supported are capable of reducing stress level
faced with the information received and the feeling of being supported.
But all this appears to indicate that this is a slow process, time must
be allowed for mourning to take place, there is a greater understanding
of the illness and the resources for handling it. As in other
psychotherapy approaches, the most definitive changes take place with
time ( Montero et al, 2006). However, we cannot lay aside the possible
support provided by the Family Association
As the general trend is to not publish negative results so we are
prevented from comparing our data with other similar studies. So, to
estimate the significance that discontinuation has represented both for
the person who have schizophrenia as well as for their families, we
have compared our results with a prior study with integrated treatment
applied continuously over a two-year period (Falloon et al 2004). By
applying the same therapy strategies as well as identical measuring
instruments a more orientate comparison can be made, despite the
different study sample characteristics. In fact, the
majority of cases in the international multi-centre study (OTP) had a
long history of illness, as opposed to our study sample. This factor
could explain the differences in initial scores between both studies.
In the OTP study the mean clinical index was 3.57 (1.57) at the start,
falling to 2.12 (sd 1.46) after two years, whereas in our case this
fell from an average of 3.13 (sd 1.41) to 1.57 (sd 1.51). The
improvement noted by the discapacity index was greater in the OTP
study: from 3.16 (sd 1.32) to 1.94 (sd 1.25) vs 2.73 (sd 0.79) to 1.64
(sd 1.49). On the other hand, reduction of family stress was somewhat
greater in the present study than in the OTP: 2.47 (sd 0.74) to 0.93
(sd 1.07) vs. OTP: 2.29 (sd 1.34) to 1.09 (sd 1.14)
The improvement detected up until the intervention was discontinued,
obtaining in some results greater benefits than in the comparative
study, strengthens the idea that this type of approach is more
effective during the first years of illness. Likewise it reports on the
quality with which the therapy strategies have been applied in this
study, increasing its validity.
Unfortunately the discontinuation of the treatment programme has led
not only to the loss of benefits therefore preventing better levels of
recovery, but it is also possible that it has produced a iatrogenic
effect by increasing risk situations. Such situations include:
interrupting anti-psychotic medication, substance misuse and dropping
out of the mental health services, although the absence of a control
group prevents this outcome from being confirmed.
Unlike other studies that claim further studies with larger samples in
order to validate the results, our recommendation is to include
reminder sessions as well as the organisation of support groups within
the study design itself. Just as antipsychotic medication can have a
prophylactic effect when administered, psychosocial treatments must
also be provided over extended periods of time and be accompanied by
reminder sessions to sustain the therapeutically and rehabilitating
benefits (Kopelowicz & Liberman, 2003).
Conclusions
The importance of combining psychosocial and pharmacological
interventions in the treatment of schizophrenia is currently
acknowledged. The factors that influence recovery are mainly vulnerable
to change by means of treatment, which may often lead to sustained
remission of the symptoms and to normal or almost normal performance
levels.
All patients are entitled to receive the best treatment available. Our
study shows that it is not enough for the evidence to be acknowledged
by professionals and interpreted as relevant and methodologically
reliable. According to Goldman (Goldman et al, 2001) it is also
required from institutional commitment to the adoption and
implementation of mental health policies capable of creating
organizational and financial initiatives.