Department of Psychiatry of the Federal University of São Paulo (UNIFESP), Brazil
University of Nottingham, UK
Correspondence: Dr Sergio Luís Blay, Department of Psychiatry, UNIVESP, R. Botucatu 740, CEP 04023-900, São Paulo, Brazil. Tel: 55-11-3816-1030; Fax: 55-11-3816-1030; E-mail: blaysl{at}psiquiatria.epm.br
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ABSTRACT |
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Aims To evaluate the effectiveness of brief group dynamic psychotherapy (BGDP) intervention in patients with minor psychiatric disorders compared with the usual clinical management shortly after treatment termination and to investigate whether intervention would show a differential effect at 2-year follow-up.
Method Patients were allocated randomly to an experimental or control group. The General Health Questionnaire (GHQ) was used as a primary outcome measure.
Results Based on improvement in the GHQ, at termination of treatment
the BGDP group showed a significant improvement in 23 out of 42 (54.8%)
compared with 11 out of 41 (26.8%) in the clinical management group. The
difference in the total improvement rate is 28% (95% C18-48)
(2=6.7; d.f.=1; P=0.009). In contrast, no
differential follow-up effects were found between the BGDP and clinical
management groups.
Conclusions Psychotherapy appears to have beneficial effects at termination of treatment but the changes attained were not stable.
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INTRODUCTION |
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METHOD |
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Comparisons were conducted shortly after treatment and at 2-year follow- up. A parallel, two-group, randomised trial research design was employed. The interval between randomisation and termination of treatment was 4-8 weeks. Randomisation was carried out using a computer-generated sequence. An assessor not involved in the treatment or initial assessment of patients allocated them to the trial groups. Treatment started within a few days of randomisation.
Outcome measures
Assessments were carried out in three waves: at intake, at termination of
treatment and at follow-up (2 years after finishing treatment). Demographic
data and information regarding previous psychiatric treatments, medical
problems and use of medications were obtained for each subject. Four
instruments were used:
Primary outcome measure
The primary outcome measure was improvement in GHQ status. Response was
operationally defined as moving from the clinical condition of
case (GHQ4) to non-case (GHQ
3).
Secondary outcome measure: multi-dimensional response
The CIS, HRSD and patient impressions were secondary outcome measures.
Multi-dimensional response was defined operationally as
achieving simultaneously a final GHQ score of 3, a CIS final score of
19, an HRSD score of
12, an OSR of
1 and patient impressions
scored as progress.
Interviewers
All evaluations were made by psychiatrists trained and experienced in the
application of these instruments and masked to the treatment procedures. A
reliability study was conducted at the beginning of the study with the
examiners evaluating the scales. The results met high standards of agreement
(intraclass correlation coefficients 0.98-1.00 for GHQ, 0.70-1.00 for CIS and
0.30-0.94 for HRSD).
The initial assessor was masked to treatment allocation. At each wave (intake, termination and follow-up) the patient was evaluated by a different examiner from the initial assessor in order to avoid any influence of preliminary contact with the patient.
Selection of patients and ethical considerations
Most patients came through the hospital's normal referral procedures,
out-patient services or emergency clinics and patients' spontaneous search for
psychiatric treatment.
The following inclusion criteria were used: male and female out-patients
aged 20-60 years. At intake, they were required to: score at least 4 on the
12-item version of the GHQ; present one of the following types of disorder
according to DSMIV: affective (mild, moderate), anxiety, somatoform,
adjustment and sexual problems; and have a duration of the current episode of
5 years. To select patients who could benefit from psychological group
intervention, their perception relating to the psychological nature of the
disturbances was examined, based on the criterion developed by Sifneos
(1987). The presence of
individual distress, inter-personal difficulties or family conflicts and the
ability to engage in a productive group activity were also considered
(Bloch & Aveline,
1996).
The following were excluded: patients evidencing psychosis, learning disability, severe personality disorder, alcohol and drug misuse, dementia or other organic brain syndrome, severe or unstable medical illness that may create a marked change in mental state; those who, simultaneously, participated in any other psychiatric or psychological treatment through the national health system (out-patient services), private clinics or self-help groups; and those who showed any difficulty proceeding with the treatment follow-up (for reasons of work, inaccurate or possible change of address, or if they provided no alternative contact in case of change of address).
Eligible patients were informed in detail of the programme and provided signed consent. The Medical Ethics Committee of the Federal University of São Paulo approved this research.
Treatment regimens
Attendance at brief group dynamic psychotherapy (BGDP)
The psychodynamically oriented psychotherapy followed the principles of
Sifneos (1987), aiming to help
the patient to identify and elaborate problematic themes such as anxiety or
interpersonal conflicts. Group techniques included questioning, timed
confrontations, dealing with intense feelings aroused by discussion,
repetitive patterns, transference and resistance. All patients included in
this group (BGDP) were to receive eight sessions of psychotherapy, twice a
week, for 1 month.
Two different therapists carried out treatment. They were residents in psychiatry in an accredited residency programme. They were in their third and fourth years of training with at least 500 hours of supervised therapy experience. Training of therapists for the trial consisted of four workshops with a senior therapist of the department staff. Therapists were instructed to treat patients using the instructions given above. This procedure constituted a general guideline and not a rigid manualised treatment (Elliott, 1998). The therapists took notes of the sessions and took part in weekly supervisions throughout the research. A senior group psychotherapist conducted the supervision.
To facilitate the adaptation and participation of the group members, each session started with one of eight video films of 20-30 min duration. Eight themes were selected in accordance with Orlinsky & Howard (1975). The videos were shown in the following order: personal relations, work, religion, alcoholism, family relations, sexuality, violence and honesty. They were chosen from an initial selection of about 50 titles and included soap opera, national films, documentaries and some cartoons. Famous and popular local artists appeared in most of these films. This procedure was intended to facilitate communication, stimulate interpersonal insights, help the patient to identify with problematic themes and create an emotional environment set in a cultural language appropriate for the socio-economic status of this patient group. Each group therapy session lasted 90 min, including the video.
The clinical management group
These patients, from now on identified as the clinical management group,
were treated individually by a psychiatrist. They received one clinical
consultation at the out-patient clinic. This lasted 30-40 min, with the
present and past clinical and familial history and mental state examination
fully annotated. Treatment could include medication, simple problem-solving
techniques, advice, manipulation of the environment, reassurance,
interpretation and involvement of the patient's partner. The majority of local
out-patient services have a treatment format similar to that of clinical
management. After the 4-week period, all patients willing to continue
treatment were referred to other services.
Follow-up
Patients completing the treatment protocol entered the follow-up phase,
conducted 25-26 months after randomisation. The follow-up was naturalistic,
with no control over further treatments that patients might receive. Follow-up
examinations were scheduled at 24 months after the end of treatment.
Sample size determination and data analysis
The study was planned to use a binary outcome: improvement. This criterion
would require demonstration of statistical superiority of the BGDP over the
clinical management group by indicating the improvement of clinical status
over base-line, at termination and at follow-up. We know that psychotherapy
has a general success rate for a treated group that is 25-30% better than an
untreated group (Lipsey & Wilson,
1993). Based on a recovery rate of 50% in one group and 20% in the
other, with a two-sided of 0.05 and a power of 0.80%, we calculated
that we would require a sample size of 40 patients in each group.
Overall group comparability at baseline, demographic characteristics and diagnostic and group mean scores on the 12-item GHQ and CIS (OSR) were evaluated using appropriate summary statistics.
The statistical analysis was performed on an intention-to-treat basis. The
effect of psychotherapy on the primary outcome measure improvement in
the GHQ was tested shortly after termination and follow-up using
Pearson's 2 or Fisher's exact test (when appropriate,
two-sided). Numbers needed to treat were evaluated
(Sackett et al,
1997). We also used a sensitivity analysis. Statistics were
re-estimated after missing cases were replaced by improvement or
non-improvement outcome
(Greenhouse & Iyenar,
1994).
Comparisons were made between groups at termination and follow-up by means of an unbalanced repeated-measures model with structured covariance matrices, using maximum likelihood as implemented in the BMDP5V program. This method is more suitable for dealing with incomplete data due to drop-outs (Everitt, 1998). The analysis incorporates any data from missing observations during the trial. The first-order autoregressive structure was used because it achieved the highest value for Akaike's information criterion. Moreover, this method produces less biased results compared with other procedures, such as last observation carried forward (Diggle, 1998).
Logistic regression was used to study which variables predict the result of treatment measured as a categorical variable at termination and at follow-up assessments. Both the descriptive analyses as well as inferential statistics were carried out using the BMDP/DYNAMIC statistical package (1993 version for DOS).
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RESULTS |
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Initial group comparability
A total of 67 women and 17 men were randomised. Sample characteristics at
intake and outcome measures are displayed in
Table 1.
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Termination of treatment
Primary outcome measure: response
At intake, all subjects were psychiatric cases showing a GHQ of 4.
Treatment effects were calculated by comparing the scores obtained by patients
at the beginning of the study with those at the end of treatment. At
termination of treatment and omitting the data related to the missing BGDP
patient, 23 out of 42 (54.8%) improved in the BGDP group and 11 out of 41
(26.8%) in the clinical management group (
2=6.7; d.f.=1;
P=0.009; 95% CI 8-48). The number needed to treat based on this
reduction was four (95% CI 2.1-11.9) (see
Table 2).
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Using the GHQ score at termination of treatment as a binary outcome, logistic regression with backward elimination was applied to investigate the following possible predictive factors: intervention, gender, first admission, age, education, OSR and presence of physical illness. Three items emerged as being capable of predicting the improvement: intervention (OR=4.72; 95% CI 1.66-13.4), gender (OR=0.33; 95% CI 0.09-1.19) and first admission to mental health services (OR=0.3; 95% CI 0.10-0.88).
Secondary outcome measure: multi-dimensional response
At termination of treatment and omitting the data related to the missing
BGDP patient, 9 out of 42 (21.4%) improved in the BGDP group and 0 out of 41
(0.0%) in the clinical management group (Fisher's exact test:
P=0.002; 95% CI 9.6-33.1). The number needed to treat based on this
reduction was four (95% CI 3-10.2) (see
Table 3).
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Follow-up
Although patients gave informed consent at entry, adherence to follow-up
was unpredictable. Subjects were contacted by telephone or post to conduct the
follow-up protocol at 2 years. Where we realised that patients were reluctant
to participate or had changed address, we carried out some interviews earlier.
Other subjects required longer periods in which to be contacted and
interviewed. Therefore, the follow-up interval varied: BGDP group, 15-32
months (patients evaluated according to time (months) of follow-up: <12=0;
12-15=4; 15-18=4; 18-23=6; 23=8); clinical management group, 9-30 months
(<12=1; 12-15=6; 15-18=6; 18-23=7;
23=5). Of the original 42 patients
in the BGDP group, 22 (52.3%) were contacted for follow-up, and of the
original 41 clinical management group patients, 25 (61%) were contacted for
follow-up (
2=NS; difference=-8.7%; 95% CI -30.2 to 12.8). All
follow-up evaluations were conducted face to face.
Primary outcome measure: response
At follow-up and omitting the data related to the missing patients, 10 out
of 25 (40.0%) improved in the clinical management group (GHQ 3) and 7 out
of 22 (31.8%) in the BGDP group (
2=NS). Statistical estimates
were unaffected by assuming that the missing cases were either a treatment
success or a failure. We also considered the response rates to be similar in
the missing and nonmissing cases (see Table
4).
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Secondary outcome measure: multi-dimensional response
At follow-up and omitting the data related to the missing patients, 6 out
of 25 (24%) improved in the clinical management group and 1 out of 22 (5%) in
the BGDP group (Fisher's exact test: NS). Statistical estimates were
unaffected by assuming that the missing cases were either a treatment success
or a failure (see Table 5).
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An unbalanced repeated-measures analysis was carried out to fit the GHQ outcome at follow-up. The main effects of intervention modality, time and the interaction of time and intervention were modelled. There was a significant group by time interaction for GHQ scores (interaction estimate=0.53; 95% CI 0.05-1.01; P=0.02), indicating that GHQ scores of patients in the BGDP group change over time at a different rate to those of patients in the clinical management group. Mean GHQ score at the 24-month follow-up is one point lower in the clinical management group than in the BGDP group.
Logistic regression of the probability of improvement was conducted, the model including those variables (at the beginning of the investigation) potentially involved with the outcome. All terms were excluded from the model, indicating that background items were not associated with predicting response at follow-up.
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DISCUSSION |
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Second aim: outcome at longer-term follow-up
We found that the differential benefits of BGDP over clinical management
(measured through GHQ status) were no longer seen. Compared with BGDP,
patients allocated to the clinical management group showed greater reductions
in GHQ total score. However, when a comparative effect of treatment did emerge
it was not a main effect but an interaction (time x treatment). Although
this difference was statistically significant, the actual difference in mean
scores was small. We analysed all relevant predictors of outcome. No term
emerged as a possible predictor using multivariate procedures at
follow-up.
Relevant information concerning the design
We would stress some features of this study: it is randomised in an area
where there are relatively few randomised studies, particularly with extended
follow-up; random allocation of patients produced well-matched samples,
particularly with regard to clinical status; and standard evaluation
techniques were used, which were applied by evaluators masked to treatment
allocation.
Why were differences between treatments reduced?
The results obtained from the patients who were satisfactorily followed up
suggest that the gains measured in the BGDP and clinical management groups
were not maintained. This situation may be interpreted in several ways. First,
it could be argued that the technique used would not have produced such large
differences as might have been desired. Eight sessions is a relatively small
number and gives little time for patients to gain insight or reorganise their
defences and symptomatology. However, there is controversy over this in the
literature. Short-term psychotherapy can produce important and lasting changes
in the functioning and attitudes of patients
(Seligman, 1995). On the other
hand, data from effectiveness studies suggest that longer-term treatments,
roughly 24 months, may produce more robust effects and may be useful in the
treatment of patients presenting the polysymptomatic clinical profile found in
everyday practice (Kopta et al,
1994; Seligman,
1995).
If we accept the efficacy of psychotherapies, there are ethical and methodological questions about studies with a placebo control group, but this means that the differences between the trial arms will be minimised because both receive effective treatments (Strayhorn, 1987).
Patients treated in our study not only had emotional disturbances but also substantial levels (25%) of comorbidity with medical problems: 37% were frequent users of out-patient services. Pilkonis et al (1984) have shown that with patients with a low income and previous interventions, therapeutic results are more limited. This may have also contributed to the reduction of differences between treatments in our trial.
Are the results generalisable?
Caution is needed with regard to generalisation of our results. First,
selection of control groups for psychosocial intervention outcome studies is
not an easy one (Strayhorn,
1987). The two very heterogeneous groups did not receive
comparable treatment and the results can be interpreted as a consequence of
attention placebo. In other words, we do not know whether it is the group
itself or the treatment within it that is effective. Another group experience,
as a control group, may be of help in solving this problem. However,
psychotherapy already has been found to be superior to a psychological placebo
in patients with somatic complaints
(Guthrie et al,
1991). In this research we wanted to compare representative
treatment procedures relevant to our health system. In addition, the exclusion
on ethical grounds of a nontreatment control fitted the design of the
effectiveness trial.
The 24-month response rate for psychological assessment was relatively poor. The most common reason for low response was, as expected, contact loss because of address change. This may have affected the outcome data, because it is possible that patients who were doing less well or who had a more severe clinical picture may have been more reluctant to complete the follow-up.
Criteria for empirically validated treatments recommend the use of manuals in conducting psychotherapy. Although this procedure is not free of controversy (Elliot, 1998), we must emphasise that the unstandardised group method employed in this study may reduce the power of generalisation.
Lastly, based on ethical grounds, the follow-up was naturalistic with no control over life events or any further treatments that patients might receive. Any such additional treatments would confound interpretation of results after extended periods of follow-up.
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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 May 23, 2001. Revision received January 2, 2002. Accepted for publication January 14, 2002.