The International Journal of Psychosocial Rehabilitation

Discontinuation of an Integrated Treatment for Schizophrenia Disorders: One-Year Outcome



Isabel Montero, PhD
Senior Lecturer of Psychiatry
University of Valencia, Spain

Ana Asencio, PhD
Clinical Psychiatrist
Gandia Hospital, Valencia, Spain

Marta Talavera
Fellow Researcher
University of Valencia, Spain 



Citation:
Montero I., Asencio A., & Talavera M.
(2007). Discontinuation of an integrated treatment for schizophrenia disorders:
 one-year outcome. 
  International Journal of Psychosocial Rehabilitation. 11 (2),  53-60

 
Corresponding author:
Isabel Montero
Department of Psychiatry.
University of Valencia
Avda Blasco Ibáñez, 15
46010 Valencia
Spain
Isabel.Montero@uv.es


Acknowledgements:
This study was financed with a grant from the Conselleria de Sanitat ( number:PI7-1/06-44) and  was approved by the Research Ethical Committee of the University of Valencia.
We guarantee that the authors have participated in all the study’s steps, included design, planning, analysis, interpretation, writing and approval of the manuscript.
We would also like to thank Julia Domínguez, Maria Sales and Cristina Simeón for their dedication and the quality of therapy treatment conducted and Pablo Cervera for his support during the final stages of this study.
 

Abstract
Introduction: 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. Objective: To study the impact of discontinuing an integrated treatment conducted in a non-experimental setting. Method:  In order to show that the person who have schizophrenia condition has improved or worsened, clinical, social and family evaluations were conducted at three points in time: at the start of the intervention, on post-treatment  and after one year. The intervention was applied to people with less than five years on schizophrenic disorder (DSM IV) and their families. Results: On post-treatment both psychotic symptoms and degree of discapacity and family stress level changed favorably with differing averages as compared to the start of 1,50 (p=0.006), 1,07 (p=0.046) and 1,43 (p= 0.000) respectively. A year after the intervention ended, all the main results had worsened, although none of the outcomes reached the mean scores of the starting point. Discussion: Unfortunately the lack of continuity  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 as interrupting anti-psychotic medication, substance misuse and dropping out of the out-clinic regime. Conclusions: Until Institutional commitment adopted and implemented mental health policies capable of creating organizational and financial initiatives, it would be recommended to include reminder sessions as well as the organisation of support groups within the study design itself.

Key Words: Integrated Treatment, Family Intervention, Recovery, Schizophrenia  


Introduction
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)

<>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.


 
References

Chisholm D and the Who-Choice Group. Selección de intervenciones psiquiátricas económicamente rentables: resultados del programa Choice de la Organización Mundial de la Salud. World Psychiatry 2005 ( Spans Edit) 3,1: 37-44

Falloon IRH. Family interventions for mental disorders: efficacy and effectiveness. World Psychiatry 2004, 2:20-8

Falloon IRH, Montero I, Sungur M and the OTP Collaborative Group.  Implementation of evidence-based treatment for Schizophrenic Disorders: two-years outcome of an international field trial of optimal treatment. World Psychiatry, 2004, 3, 2:104-109

Goldman H, Ganju V, Drake R, Gorman P, Hogan M, Hayed P, Morgan O.  Policy implications for implementing evidence-based practice. Psychiatric Services 2001, 52, 12: 1591-97

Kopelowicz A, Liberman RP. Integration of care: integrating treatment with rehabilitation for persons with major mental illness. Psychiatric  Services  2003, 54 (11): 1491-98

Lenroot R, Bustillo JR, Lauriello J,  Keith SJ  Integration of Care: Integrated Treatment of Schizophrenia.  Psychiatric  Services  2003, 54:1499-1507

Mauser KT, Bond GR, Drake RE. Community-Based treatment of Schizophrenia and other severe mental disorders: treatment outcome? Medscape Mental Health, 2001,6, 1:1-31

Montero I, Masanet MJ, Bellver F, Lacruz M.  The long-term outcome of family intervention strategies in schizophrenia. Comprehensive Psychiatry  2006, 47,362-367

Petersen L, Jeppesen P, Thorup A, Abel M, Olenschlaeger J, Ostergaar Ch, Kroup G.  A randomized multi-centre trial of integrated versus standard treatment for patients with a first episode of psychotic illness. BMJ 2005, 331-602 (originally published online; downloaded 3 Feb 2007)

Pharoah FM, Mari JJ, Steiner D.  Family interventions for schizophrenia (Cochrane systematic reviews) In: Cochrane Library, Issue 1, Oxford: Update, software 2003

Sellwood W, Tarrier N, Quinn J, Barrowclough C. The family and the compliance in schizophrenia: the influence of clinical variables, relatives´ knowledge and expressed emotion. Psychological Medicine, 2003, 33, 91-96

Thornicroft G & Susser E. Evidence-based psychotherapeutic interventions in the community care of schizophrenia. British Journal of Psychiatry, 2001, 178,2-4

Torrey W, Drake RE, Dixon L et al. Implementing evidence-based practice for persons with severe mental illness. Psychiatric Services 2001,14.45-50





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