Two Strategies for Family Intervention in Schizophrenia

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Two Strategies for Family Intervention in Schizophrenia: A Randomized Trial in a Mediterranean Environment by Isabel Montero, Ana Asencio, Ildelfonso Hernandez, M a Jose Masanet, Maria Lacruz, Francisco BeUver, Mercedes Iborra, and Isabel Ruiz

Controlled intervention studies carried oat in families of schizophrenia patients have been shown to have a positive impact in relapse prevention, but it remains to be seen whether different forms of family intervention affect outcomes other than relapse and hospital readmission in different ways. This study compared the outcome profile of relevant clinical variables after two different family intervention strategies for schizophrenia patients in public health care in a Spanish sample. We conducted a randomized controlled study comparing (1) a relatives group (RG) and (2) a single-family behavioral family therapy (BFT), both offered as standard treatment in one catchment area in Valencia. All randomized patients were included in the main analysis, and all cases remained in the therapy group to which they were originally assigned regardless of whether they suffered a relapse. The relapse rate at 12 months for the 87 cases studied was not significantly different in the two groups, but the two approaches did affect outcomes other than relapse and rehospitalization (such as social functioning, dose of antipsychotic medication, "delusions" and "thought disorder") in different ways. The BFT approach offered more advantages than the RG approach. The results suggest that these approaches should always be implemented in a clinical environment in a Mediterranean setting. Keywords: Schizophrenia, family intervention, psychoeducation, relatives' group, behavioral family therapy, relapse prevention. Schizophrenia Bulletin, 27(4):661-670,2001. Today there is enough scientific evidence to support the clinical recommendation of including family interventions in the routine care for all schizophrenia patients because of the positive impact on relapse prevention that these interventions can have (Man and Streiner 19%; Penn and Mueser 1996).

Send reprint requests to Prof. I. Montero, Dept. of Medicine, Psychiatric Unit, University of Valencia, Avda. Blasco Ibafiez, 17,46010 Valencia, Spain; e-mail: [email protected].

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To date, most studies have been carried out in English-speaking cultures, and we know very little about how these strategies work in other cultural environments. In a group of Hispanics in the United States, Telles and colleagues (1995) found an increase in psychotic relapse after behavioral family intervention, as compared to a control group, and suggested that an effort should be made to find more ego-syntonic strategies for each population. Some students from China (Xiong et al. 1994; Zhang et al. 1994) show that a relatively simple psychoeducational approach can be implemented in the community and have an important effect on relapse. However, their social, familial, and care structures are so different in comparison with those in Europe that it is not possible to extrapolate their results to our cultural setting either. Mediterranean cultures are known to be particularly centered on the traditional family framework, far more than other Central and Northern European cultures. In addition, some data indicate that different expressed emotion profiles in relatives from schizophrenic patients are to be expected; relatives show greater overinvolvement and face-to-face contact between patients and relatives and lower hostility and criticism (Gutierrez et al. 1988; Are"valo and Vizcarro 1989). Therefore, we would also expect an idiosyncratic response to family intervention. Although most family intervention programs are based on providing family members with more information about the disorder and strategies to improve stress management, the practical approaches of the different programs vary. Few studies have compared different approaches to family intervention, and these did not find any significant difference in the relapse rate (Tarrier et al. 1988; Leff et al. 1990; Zastowny et al. 1992; Schooler et al. 1997). Only McFarlane and colleagues (1995) found the relapse rate for multiple-family intervention to be lower than that for single-family treatment.

Abstract

Schizophrenia Bulletin, Vol. 27, No. 4, 2001

I. Montero et al.

mation to a reasonable degree. To ensure continuity of care, the clinical followup of each patient was conducted as usual in the outpatient clinic of the patient's catchment area, and all patients were prescribed antipsychotic drugs by their psychiatrists. A fixed dose was not necessary, and depot preparations were used in instances of'poor compliance. No patients were attending any kind of specialized social rehabilitation unit

But more specific questions have yet to be answered in order to optimize the use of these family interventions. If we take into account all the complexity of schizophrenia (Leff 1994), in order to provide comprehensive treatment for it we will also have to assess the results in a multidimensional way, taking into account variables other than relapse. The aim of this study was to compare the different profile of outcome of two alternative strategies for psychoeducational intervention in families with schizophrenia patients in a Spanish sample. Our hypothesis was that if we compared two different family strategies already shown to be effective in other cultural settings, we would find that both interventions, carried out within the everyday clinical care in our setting, would be equally effective in reducing relapse and readmission rates but would produce different outcomes in other relevant variables.

Method We conducted a randomized, controlled study comparing two different family strategies, (1) an RG, and (2) singlefamily BFT. The interventions were offered to all types of families as standard therapeutic treatment within the Spanish public health system. The potential cases were all the schizophrenia patients attending the outpatient mental health facilities of one catchment area in Valencia (133,000 inhabitants). The area is one of the most densely populated districts of Valencia but lacks community resources that could benefit schizophrenia patients. To be included in the study, subjects needed (1) to have diagnoses of schizophrenia according to DSM-III-R (American Psychiatric Association 1987); (2) to have had a recent acute psychotic relapse (within the previous 6 months), with or without hospital admission, and be in remission; (3) to be between age 15 and age 45; (4) to have lived with relatives for the previous 3 months; and (5) to be planning to remain in the same household for the 12-month period after being enrolled in the study. Patients with a background of substance abuse were excluded only if they were physically dependent at the time of the study. From June 1992 to February 1997, a total of 87 patients and their relatives were referred to the program consecutively by their psychiatrists. Of these, 41 were assigned at random to an RG and 46 to single-family homebased BFT. Randomization was carried out by an independent institution (Miguel Hernandez University, Alicante) using the Epiinfo method with sealed envelopes containing random numbers. The study was approved by the institutional review committee of the University of Valencia. Treatment did not begin until the patient was clinically stable, with positive psychotic symptoms in remission, and able to follow the sessions and process the infor-

Training and Supervision. Three psychiatrists and one psychiatric nurse, all members of the psychiatric department staff, were trained intensively in BFT for 2 months

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Interventions. In both intervention strategies, patients were always present at two initial educational sessions and then continued to undergo the assigned intervention (BFT or RG), regardless of whether they suffered a relapse. The length of the active intervention was 12 months in both groups, and there was no significant difference between the groups with regard to the amount of clinical contact with the therapist. Both sets of famines were seen on the same schedule: weekly for the first 6 months, every 2 weeks for the next 3 months, and monthly for the last 3 months. BFT. The behavioral intervention framework addressed each family unit, including the patient, and was carried out at home. It encompassed three different modules introduced sequentially and integrated later: patient and family education about schizophrenia, training in communication skills, and teaching and practice of problem-solving techniques designed to help families think of solutions and apply them (Falloon et al. 1984). RG. This program was developed on the basis of research into relatives' expressed emotion (EE) (Leff et al. 1982). It began with two educational sessions about schizophrenia for the patient and relatives, provided individually for each family unit at the health center. The sessions that followed were attended by only the relatives, and they aimed to teach problem-solving skills, reduce criticism and overinvolvement, reduce social contact between patient and relatives, expand social networks, and lower expectations. The participants were invited to take part in the weekly RG that took place at the mental health center. The RG was designed as an open group: new relatives were incorporated as they were referred to the program, always after the educational sessions. The mean number of participants (usually one per patient, occasionally two) in each session was 8—10, and there was always a mixture of relatives who had just joined the group and others who had been attending longer. The sessions lasted approximately 90 minutes and were led by two therapists, providing the opportunity to model good communication and learn managing strategies in the context of calm discussion (Falloon et al. 1984).

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Schizophrenia Bulletin, Vol. 27, No. 4, 2001

by the team leader (I.M.), who was in turn trained by Prof. Falloon. Another researcher was trained in Leff's strategy and trained the rest of the team. The participating staff was selected according to their interest in integrated therapeutic approaches. They took part on a purely voluntary basis and were obliged to fit these activities in with the rest of their clinical duties. Manuals, workbooks, and videotapes were used in training. The therapists met weekly with I.M. for monitoring of progress and supervision.

Assessment A battery of measurements was conducted by a trained and independent researcher. The initial evaluation was conducted blind with regard to the intervention groups to which patients had been assigned. This assessment was repeated for the whole sample 12 months after the baseline assessment Although it was not possible to carry out a double-blind assessment, the project staff had no influence on readmission decisions, assessment of clinical exacerbations, or medication regime, and therefore these are independent outcome measures. Psychotic relapses were identified on the Psychiatric Assessment Scale (PAS, Krawiecka et al. 1977) applying Vaughn and colleagues' criteria (1984, p. 1171): "A total increase of three points on one or more of the three scales was designated a significant exacerbation. If change occurred on only one scale, a two-point increase was also designated as a significant exacerbation." Other relevant endpoints covered the clinical condition/severity of symptoms (PAS), social functioning (Disability Assessment Scale-II [DAS-H], Montero et al. 1988), degree of knowledge about schizophrenia (Knowledge About Schizophrenia Inventory), psychological distress in relatives (General Health Questionnaire-28 Items [GHQ-28]), and EE in the key relative (Camberwell Family Interview). All scales and interviews were used in the Spanish versions, published elsewhere (Lobo et al. 1986; Perez-Fuster et al. 1989; Montero and Ruiz-Perez 1992; Montero et al. 1992, 1998). In addition to these outcome measures, a standardized history and selection of standardized background measures were drawn up. The treating psychiatrist assessed medication compliance using all available sources of information. Compliance was measured globally, and blood levels were not measured routinely. Medication data were recorded by an independent researcher and converted to mean chlorpromazine equivalents (Kane and Marder 1993).

Results The basic characteristics of the patients and their families in the two groups were very similar (tables 1 and 2). However, the BFT group showed a higher, but not significant, proportion of high EE families. Of the 87 cases involved, 26 percent failed to attend any therapeutic session after the baseline assessment, 14 percent dropped out at some point in the program having attended less than 75 percent of the sessions, and 52 (60%) completed the full course of treatment (figure 1). No clinical or sociodemographic differences were found between those who never attended and the dropouts, and none of those assigned to one group migrated to the other. There was no significant difference in the relapse rate of each strategy: 33 percent (15/46) in the BFT and 22 percent (9/41) in the RG (p = 0.26), with a risk difference of 10.66 percent (95% CI: -7.89, 29.21). This difference fell to 6.76 percent (95% CI: -16.03, 29.55) among those who completed the programs. In subjects who suffered a psychotic relapse, the mean time span between entering the program and the relapse being detected was also similar in both groups: 6.7 months (standard deviation [SD] = 3.1) in the BFT and 8 months (SD = 3.5) in the RG (p = 0.37). The rate of hospital readmission for the whole sample was 10.3 percent,

Data Analysis Two different analytical approaches were carried out based on the degree of adherence to the assigned interven-

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tion. On the one hand, data on outcome variables not dependent on adherence to intervention (relapse rate, readmission, severity of clinical condition, and medication) were analyzed on an intention-to-treat basis (i.e., comparisons included all randomized patients, according to the assigned therapy group). On the other hand, the following stage involved analyzing all the data of both intervention groups, including only the patients who completed the full program, consequently providing information on all variables (including, in addition to the previous ones, patients' social functioning, dose of antipsychotic medication, relative's knowledge about the illness, EE status, and psychological distress). The baseline characteristics of the two groups were compared using the following tests as appropriate: chisquare, Student t or Mann-Whitney U tests. Posttreatment relapse and readmission rates were compared by means of the chi-square test and risk differences with 95 percent confidence intervals (CIs). For other outcome measures, changes in proportions, means, or scores from baseline were estimated, and the statistical significance in both intervention groups was established by means of the Wilcoxon paired test or McNemar test when appropriate. Mean differences and their 95 percent CIs were calculated before and after intervention.

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Table 1. Patients' characteristics according to intervention group Characteristics

Total (n = 87)

BFT (n = 46)

Age, yrs; mean (SD)

26.8 (6.3)

27.2 (6.6)

26.4 (5.9)

0.56

Sex, n male/n female

58/29 (2%)

31/15(2.1%)

27/14(1.9%)

0.87

Marital status, % single

88.5

88

90

0.38

Education, % primary school

72

67

78

0.26

Employment, % unemployed

82

80

85

0.54

Age at onset, yrs; mean (SD)

21.3(4.5)

21.4(4.6)

21.1 (4.4)

0.33

Length of illness, yrs; mean (SD)

5.5(4.1)

5.7 (4.5)

5.3 (3.6)

0.61

Previous admission, % other than index admission

30

30

30

0.90

Duration of previous admission, yrs; mean (SD)

38 (34.3)

31.4(27.4)

44.9 (39.9)

0.22

Severity of symptoms, mean PAS score (SD)

6.3 (3.2)

6.6 (3.2)

5.9 (3.2)

0.33

Social adjustment, mean DAS-II score (SD)

3.8(1.0)

3.8(1.1)

3.9 (0.8)

0.65

Medication, n (%) Noncompliance Maintenance dose1 High dose2

7(8) 49(56) 31 (36)

4(9) 26(56) 16(35)

3(7) 23(56) 15(37)

0.32

RG

1

£ 500 mg CPZ equivalent.

2

> 500 mg CPZ equivalent.

Table 2. Family characteristics according to Intervention group Characteristics

Total 1

BFT

RG

Extended household, n (%)

46 (52.8)

26 (56.5)

20 (43.5)

0.47

High EE, n (%)

28(57.1) 34 (76.7)

21 (42.8) 22 (54.5)

0.29

> 35 hours/wk contact, n (%)

49 (56.3) 56 (64.4)

0.39

Psychological distress, mean GHQ-28 items (SD)

8.1 (6.1)

8.4 (6.7)

7.8 (5.3)

0.67

Knowledge, mean KASI score (SD)

14 (3.8)

14.5 (4.0)

13.8(3.3)

0.41

Note.—BFT = behavioral family therapy; EE = expressed emoton; QHQ = General Health Questionnaire; KASI = Knowledge About Schizophrenia Inventory; RG = relatives group; SD = standard deviation. Continuous variables were examined for differences by the Student f test. Proportions were compared by the chi-square test. 1

Three or more relatives.

8.7 percent in the BFT compared to 12.2 percent in the RG (p = 0.59). No difference was recorded in the length of hospital stay of each group (p = 0.74). Table 3 shows the results related to the severity of clinical condition and pharmacological treatment of both groups at the baseline and after treatment The global PAS score suggests favorable development in both groups, but the "delusions" and "thought disorder" scores of those in the BFT group had significantly decreased at posttreatment, whereas those in the RG group had not. Medication compliance over time remained at the same high level in both groups. However, among BFT patients the mean dosage was significantly

lower at posttreatment in comparison with the baseline dosage (from 542.2 to 374.1 milligrams chlorpromazine equivalent), while in RG patients the mean dosage remained stable. The social adjustment adopted as a global DAS-FI measure showed significant improvement in both intervention strategies (figure 2), but BFT produced significant changes in more items than the RG, such as selfcare (p = 0.010), use of leisure time (p = 0.0001), participation in household (p = 0.010), friction in interpersonal relationships (p = 0.010), and interest in getting ajob(p = 0.003).

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Note.—BFT = behavioral famliy therapy; CPZ = chlorpromazine; DAS-II = Disability Assessment Scale-il; PAS = Psychiatric Assessment Scale; RG = relatives group; SD = standard deviation. Ail continuous variables were examined for differences by the Student f test. Proportions were compared by the chi-square test

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Two Strategies for Family Intervention

Figure 1. Losses during the time of Intervention Number of ca**s (%)

1OT

Table 3. Clinical condition and pharmacological treatment In each strategy at baseline and posttreatment (n = 87 [46 BFT, 41 RG]) Group

Baseline1

Posttreatment1

Difference2

p value3

BFT RG

6.6 (3.2) 6.1 (3.3)

5.5 (3.3) 5.4 (3.4)

1.1 0.7

0.032 0.035

Delusions

BFT RG

2.8(1.6) 2.5 (1.6)

2.2(1.7) 2.1 (1.6)

0.6 0.4

0.041 0.113

Hallucinations

BFT RG

2.1 (1.6) 2.1(1.5)

2.0(1.6) 1.7(1.3)

0.1 0.4

0.582 0.107

Thought disorder

BFT RG

1.7(1.1) 1.5(0.8)

1.3(0.8) 1.5(0.9)

0,4

0

0.001 0.861

BFT RG

542.2 (70.5) 589.9 (66.7)

374.1 (51.6) 532.4 (65.9)

168.1 57.4

0.014 0.321

BFT RG

4(9) 3(7)

4(9) 8(19.5)

0.46(0.15-1.40)

Variable Psyctiopathology Total PAS score

Medication Daily CPZ equivalent dosage Nonadherence

Note.—BFT = behavioral family therapy; CPZ = chlorpromazine; RG = relatives group. 1 Mean'(standard deviation) In ail except •Nonadherence' row, where information is in n (%) format. 2 Difference in mean value, baseline, and posttreatment, in all except 'Nonadherence" row, where information is risk difference (confidence interval). 3 Differences before and after intervention in psychopathotogy and medication were evaluated by means of the Wilcoxon matched-pairs signal-ranks test.

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T*n»

EMofMrwttm

I. Montero et al.

Schizophrenia Bulletin, Vol. 27, No. 4, 2001

Figure 2. Changes In social adjustment Items (DAS II)*

RG

BFT

Illllllll IN Mill I Bat-ttBc

* High score Indicates poor adjustment

Table 4. Changes In family characteristics according to Intervention group (n = 52) RG

BFT Variables

Baseline

EE High EE, % £ 6 critical comments, % Hostility, % Emotional overinvolvement > 3, % Positive comments £ 2, % Warmth > 2, % > 35 hours/wk face-to-face contact, %

56.6 23.3 7.0 43.3 43.3 13,0 76.7

Psychological distress, mean (SD) Knowledge about the illness, mean (SD)3

9.50(11.5) 15.54(3.5)

Posttreatment 6.6 0.0 0.0 3.3 67.7 23.0 60.0

P

Baseline

0.0011 0.0231 1.0001 0.0011 0.0451 0.8521 0.0261

63.6 23.8 19.0 52.4 50.0 19.0 54.5

Posttreatment 31.8 9.5 10.0 38.1 36.4 43.0 50.0

P 0.01561 0.2481 0.1331 0.5051 0.4491 0.3731 1.0001

5.83 (5.7)

0.121 2

9.36 (4.9)

8.09(7.1)

0.3092

19.25(2.9)

0.001 2

15.00(3.6)

18.91 (3.2)

0.001 2

Note.—BFT = behavioral family therapy; EE = expressed emotion; RG = relatives group; SD= standard deviation. 1

McNemarTest.

2

f test for paired samples.

3

Wilcoxon matched-pairs signal-ranks test Higher scores mean better knowledge.

managed to increase the percentage of positive comments and significantly reduce the number of patients with more than 35 hours of face-to-face contact per week, unlike the RG. Warmth and hostility also underwent positive changes in both strategies but did not become statistically significant.

The interventions also had a positive effect on the key relatives (table 4). Both types of intervention reduced the family EE level. Highly noteworthy in this respect was the BFT approach, which managed to reduce EE in every case. There was also a reduction in critical comments and emotional overinvolvement. Likewise, the BFT

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iiiiniii MM Mill

Two Strategies for Family Intervention

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Profile Outcomes of the Two Different Family

The degree of knowledge concerning the nature and treatment of the illness also improved considerably in both types of treatment, both overall and in each of the six items in the questionnaire when analyzed separately. On the other hand, and contrary to our forecasts, the reduction in the level of psychological distress in the key relative was not significant, and the mean score in the GHQ of both groups remained at or just above the cutoff point

Discussion Several of our methods deserve comment. Beginning with statistical analysis, the intention-to-treat model took no account of the frequency of attendance. Subjects who attended the sessions infrequently and those who never attended them after being randomized were also evaluated. Consequently, dropouts had a detrimental effect on measures of the effectiveness of intervention, but this method ensures strict compliance with randomization and thus serves to ensure internal validity (Buchkremer et al. 1997). It also brings us closer to real clinical conditions. There was no sample selection based on medication compliance, clinical severity, or family type, as required in comparable studies (Falloon et al. 1984; Tarrier et al. 1988; Leff et al. 1990). This study's sample began with perhaps greater morbidity but that was more "typical" and representative of everyday clinical practice, which may explain some of the modest clinical results. In addition, the fact that our catchment area does not provide any community resources for schizophrenia patients sets our results in the lower limit of its effectiveness and can only be compared with similar studies performed in Englishspeaking countries. Unfortunately, we were not able to evaluate all the resulting data concerning the dropout subgroup, such as social adjustment, EE, or changes in relatives' psychological distress. Hence, such outcome measures were analyzed only for patients who completed the full program. As concerns the generalization of our results, it must be remembered that our findings provide information about the effect of these interventions on those patients who were referred for therapy and were willing to accept it. It was observed when analyzing data in a previous study with the same sample that dropout patients and those who complete the programs have different clinical and family characteristics (Montero et al. 1999), a fact that must be taken into account. Nevertheless, our global sample represents the wide spectrum, both clinically and demographically, of all the schizophrenia patients living with their families and attending the psychiatric outpatient facilities of the catchment area.

Further studies will be needed to investigate the additional and interactive effects of medication and psychosocial treatments because for most patients with

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Approaches. The fact that the differences observed with a CI of 95 percent were not significant supports the hypothesis that both programs are equally effective in preventing psychotic relapses and reducing the number of hospital readmissions. We did, however, find that both therapeutic modalities affected outcomes other than relapse and readmission rate in different ways. The fact that BFT involves the patient working toward his or her personal aims could at least partly explain why BFT participants improved social adjustment more than RG participants did. A reduction in relatives' EE may well be caused by the fact that psychosocial treatment affects patients' psychological functioning, which could in turn reduce EE. Also particularly noteworthy was the reduction in critical comments and emotional overinvolvement, the latter appearing to be die most resistant to change in studies in English-speaking countries. The significant reduction of face-to-face contact in the BFT group could be attributed in part to the much higher percentage of high-contact families at baseline in the BFT group. The likelihood of a significant reduction in the RG program was far lower. However, the absolute magnitude of the observed reduction of high-contact families in the BFT group should be considered. Both approaches encourage compliance with medication, keeping compliance at a high level in comparison with levels reported in the literature. McFarlane and colleagues (1995) mentioned a noncompliance median of about 46 percent, with similar results in other studies (Goldstein et al. 1978; Falloon et al. 1982; Hogarty et al. 1986; Tarrier et al. 1988; Leff et al. 1990; Schooler et al. 1993). However, contrary to the results of these intervention trials, our results indicate that the two formats affect dosage reduction in different ways. It has been suggested that the dosage can safely be lowered when combined with a therapy that effectively reduces stress in the environment. Unfortunately, it was not possible to control for medication, and the patients were given the dosage their physicians considered optimum for their needs. It is possible that by involving all the family members, the BFT approach spreads the family burden and indirectly reduces stress in the environment quickly and effectively. In the RG, on the other hand, it is common for just one member of the family—usually the mother—to attend regularly, while the other members of the family do not benefit from the positive effects of treatment.

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schizophrenia a moderate dose of medication appears to be the best clinical recommendation (Schooler 1995). Contrary to expectations, the RG did not influence relatives' health to a greater extent. This second approach excludes the patient and allows the relative not only to share his or her feelings but also to find support, understanding, and practical advice from the other group members. However, these mechanisms are probably not sufficient to achieve a significant decrease in psychological distress.

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Effectiveness of BFT in a Mediterranean Setting. The current study also tested whether BFT in a home setting worked in a sample of schizophrenia patients in a Mediterranean culture. In our case, and unlike the results reported by Telles and colleagues (1995), BFT was not felt to be stressful and intrusive, and it did not produce adverse effects, despite being based on a model that was developed in English-speaking countries and might have appeared beforehand to be least assimilated to the Mediterranean environment. What is more, the dropout rate in this line of therapy was lower than that of the RG (33% as opposed to 49%), and the reduction in psychotic symptoms was greater than that observed in the RG. It is true that the comparative data provided by Telles refer particularly to an immigrant subgroup of more acculturated patients with a very low cultural level, but we did not observe any differences in the level of education either (data not shown). According to our results, not only does this line of therapy adapt well to our setting, it also offers additional advantages. The difference between this study and studies in English-speaking countries is possibly due to the different family structure and makeup, and we could venture that the BFT model works much better in extended households than in families with just one or two members. Up to 53 percent of the cases in this study involved more than one sibling in addition to both parents. The results of this study support the feasibility of using these treatments effectively in a "front-line" everyday clinical setting, where they are most likely to be needed, and refutes the assumption that such positive findings are the result of using exceptionally good resources. Our study suggests the existence of further advantages depending on the approach adopted, regardless of the family's degree of commitment with the treatment program. Consequently, we believe that more indepth research is required before deciding to apply any given therapy model and allocating resources, all of which will depend on the setting in which the model is to be applied.

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Acknowledgments This research was supported by a grant from the Spanish Sanitary Research Fund (Fondo de Investigaciones Sanitarias). We are most grateful to Prof. Julian Leff and Prof. Ian Falloon for their always-helpful suggestions and encouragement.

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I. Montero et al.

The Authors Isabel Montero, M.D., Ph.D., is Senior Lecuturer, Department of Psychiatry, Valencia University School of Medicine, Valencia, Spain. Ana Asencio, Ph.D., is Senior Research Associate, University of Valencia, Valencia, Spain. Ildefonso Hernindez, Ph.D., is Professor of Clinical Epidemiology, Department of Preventive

Medicine, Miguel Hernandez University, Elche-Alicante, Spain. M* Jos6 Masanet, Ph.D., is Senior Registrar; Francisco Bellver, M.D., is Registrar; Maria LaCruz, M.D., is Registrar; and Mercedes Iborra is Psychiatric Nurse at the Clinical Psychiatric Department, University of Valencia, Valencia, Spain. Isabel Ruiz, Ph.D., is Consultant Research Fellow, Elche University School of Medicine, Alicante, Spain.

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