Department of Psychiatry, Leicester Warwick Medical School
Brandon Unit, Leicester General Hospital, Leicestershire and Rutland NHS Healthcare Trust
Department of Psychiatry, Leicester Warwick Medical School, Leicester, UK
Correspondence: Dr R. L. Palmer, University Department of Psychiatry, Brandon Unit, Leicester General Hospital, Leicester LE5 4PW, UK. Fax: 0116 225 6235; e-mail: dkb5{at}le.ac.uk
Funding detailed in Acknowledgements.
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ABSTRACT |
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Aims To investigate the efficacy and effectiveness of self-help with and without guidance in a specialist secondary service.
Method A randomised controlled trial comparing three forms of self-help over 4 months with a waiting-list comparison group and measurement of service consumption over the subsequent 8 months.
Results Self-help delivered with four sessions of face-to-face guidance led to improved outcome over 4 months. There is also some evidence to support the use of telephone guidance. A minority of participants achieved lasting remission of their disorder in relation to self-help, but there was no significant difference in final outcome between the groups after they had progressed through the stepped care programme. Patients initially offered guided self-help had a lower long-term drop-out rate.
Conclusions Guided self-help is a worthwhile initial response to bulimia nervosa and binge eating disorder. It is a treatment that could be delivered in primary care and in other non-specialist settings.
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INTRODUCTION |
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METHOD |
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Eligible participants were a consecutive series of patients presenting with bulimia nervosa, partial syndromes of bulimia nervosa or binge eating disorder to a specialised secondary eating disorders service for adults. Most were referred directly from primary care to the Leicester Eating Disorders Service, which has a specific catchment area. Diagnoses were made according to DSMIV (American Psychiatric Association, 1994), and partial syndromes of clinical severity were described as cases of eating disorder not otherwise specified within that classification. Exclusion criteria were as follows: significant risk of major self-harm; comorbid psychotic disorder or major substance misuse; severe electrolyte disturbance; major comorbid physical disorder; a body mass index below 18 kg/m2; a rapidly declining weight; and difficulties with spoken English or with reading and writing of a kind that would have impeded the research.
Patients were seen and assessed clinically within the service. Those judged to be eligible and without exclusion criteria were asked whether they were willing to take part in the trial. A written explanation and consent form was used. Those who declined to take part were offered treatment within the service in the usual way. This usually involved being placed on a clinical waiting-list. This list not to be confused with the waiting-list condition of the trial typically involved a wait of several months unless there were special circumstances. Those who consented to take part were given an early appointment for a first research assessment. They were subsequently randomly allocated to one of the four conditions.
Some patients were either already taking antidepressant medication, or were deemed to have clinical depression and were prescribed such medication at clinical assessment. These drugs were continued at stable dosage throughout the trial. The participants taking antidepressants were randomised separately so as to ensure their even distribution between the four treatment conditions, as were bulimia nervosa and non-bulimia nervosa cases. Randomisation was from blocks of eight. Eight envelopes with treatment assignments were put in a larger envelope and constituted the pool from which a participant's treatment was drawn. The pool was replenished with a further block of eight when only two envelopes remained.
Outcome measures
The principal measure of eating disorder was the Eating Disorder
Examination (EDE; Fairburn & Cooper,
1993) and the results reported here are based upon this
instrument. This interview was given at intake and at 4, 8 and 12 months.
Unfortunately it was not practical for the research assessor to be masked to
treatment assignment. Self-report measures were used also but are not reported
here.
Outcome was defined in two ways. One was the percentage change in key behavioural symptoms on the following EDE scales: objective binge episodes, self-induced vomiting and the global score. No improvement or a less than 25% reduction in key symptoms was categorised as not improved. An improvement of 25-75% was categorised as some improvement and if there had been more than a 75% reduction in symptoms the patient was categorised as importantly improved. The other outcome was full behavioural remission, defined as an absence of either bingeing or vomiting in the month before the relevant assessment.
Treatment conditions
The details of the four treatment conditions were as follows.
Waiting-list
The patient was given an appointment for reassessment after 4 months, with
the expectation of then being offered one of the full out-patient therapies
available within the service either cognitivebehavioural
therapy or interpersonal psychotherapy
(Fairburn et al,
1993; Fairburn,
1997).
Self-help with minimal guidance
The patient was given a copy of Overcoming Binge Eating together
with a brief explanation by a therapist of how to use it (minimal guidance).
Patients in this group were also given an appointment for reassessment after 4
months, with the expectation that they would be offered further therapy
according to their needs as assessed at that time.
Self-help with face-to-face guidance
The patient was given a copy of Overcoming Binge Eating by a
therapist immediately after the research assessment, and then invited for four
out-patient guidance sessions spread over 4 months. Typically these sessions
lasted about 30 min and occurred 2 weeks, 4 weeks, 2 months and 3 months after
the research assessment. Again, the patient was reassessed at 4 months.
Self-help with telephone guidance
Patients were treated in the same way as the face-to-face guidance group
except that the guidance was delivered through pre-arranged telephone calls.
The telephone sessions were also of about 30 min duration.
In both the face-to-face and telephone guidance conditions the sessions were used to encourage patients and to help them to organise their use of the book. Those offering guidance were nurse therapists experienced in the treatment of eating disorders; however, they confined themselves to offering guidance in the use of the book rather than other advice or therapy.
Follow-up
At the 4-month reassessment appointment, patients were offered further
treatment according to their clinical state and the degree to which this had
changed since first assessment. Except in the case of unexpected and
overriding clinical need, the offer of further treatment was made along the
following lines. If there had been little or no improvement (categorised as
not improved) the patient would be offered full therapy (either
cognitivebehavioural therapy or interpersonal psychotherapy), as
outlined above for participants in the waiting-list condition. Patients
categorised as importantly improved would be followed up and
reassessed, but not given further treatment (although they could keep the
book). If improvement fell between 25% and 75% (categorised as some
improvement), the patient would be offered more guided self-help of the
kind already experienced.
Participants were subsequently reassessed at 8 months and 12 months. At 8 months, the offer of further treatment was governed by the same rules as applied at 4 months. After the final assessment 12 months after entry to the trial, the patient was offered further treatment as judged necessary by clinical criteria.
Analysis
The outcomes at 4 months for the different treatment conditions were
analysed on both a completer basis and an intention-to-treat basis, with the
assumption that those dropping out had not improved. The outcome and service
consumption measures at 12 months were compared only on an intention-to-treat
basis.
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RESULTS |
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By the time of the first reassessment at 4 months, 30 (25%) had dropped out
of treatment. Drop-out rates varied from 22% in the minimal guidance group to
29% for the waiting-list group (Table
3). These differences were not statistically significant.
Table 3 shows the numbers who
dropped out and who were assigned to each of the improvement categories at 4
months. Analysing these results on an intention-to-treat basis with the
assumption that those who dropped out were not improved, and comparing
individuals with a negative outcome (drop-out or no improvement) with those
who showed either some or important improvement, there was a highly
significant linear trend in relation to intensity of treatment. Those who had
the most treatment had the greatest chance of improvement. Of those in the
waiting-list group only 19% showed at least some improvement, compared with
25% in the minimal guidance group and 36% and 50% in the telephone and
face-to-face guidance groups respectively. On partitioning the overall
2, it was apparent that the heterogeneity of the groups mainly
reflects differences in improvement between the face-to-face guidance group
and all other groups combined (
2=5.77, d.f.=1,
P=0.016). No other between-group comparison within the partitioning
analysis reached statistical significance.
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The efficacy of the individual treatments was examined further by comparing
the outcome of each treatment with that of the waiting-list condition using
the much more stringent criterion of full behavioural remission
abstinence from both bingeing and vomiting. These individual analyses were
performed using data from participants who completed the treatments rather
than on an intention-to-treat basis. Results for both the face-to-face and
telephone guidance groups were significantly better than the waiting-list
group (2=4.42 and 4.75 respectively, P<0.05). This
was not the case for the minimal guidance group. However, the actual rates of
such remission were low. No patient achieved remission while on the
waiting-list. Remission occurred in 2 (6%) of the minimal guidance group, 3
(10%) in the face-to-face group and 4 (14%) in the telephone guidance group.
Of these 9 participants who had received some form of self-help and were in
remission at 4 months, 8 were assessed at 12 months: 7 were found to be still
abstinent from both bingeing and vomiting. These patients had received no
further therapy and seemed to have achieved lasting remission through
self-help alone.
Follow-up
After 4 months, the treatment received by the patients was determined by
clinical need and the trial rules rather than randomly by allocation to
treatment group. At the 12-month reassessment 77 patients were seen: 64% of
the original number. However, 15 (19.5%) of those assessed at 12 months had
effectively dropped out of clinical contact (2 had been withdrawn during the
later stages of the trial for clinical reasons).
Table 4 shows the outcomes and
service consumption at 12 months. There was a tendency for the dropout from
the study at 12 months to be higher in the waiting-list and minimal guidance
groups (42% and 50% respectively) than in the telephone and face-to-face
guidance groups (25% and 28% respectively). Drop-out with guided self-help was
significantly lower when compared with the other two groups combined
(2=5.77, P<0.05).
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Analysis of outcome at 12 months was made using groups based upon intention-to-treat, since the aim was to compare the effectiveness of the initial treatment approaches as part of an overall treatment package. The outcome criterion was full behavioural remission, in the sense of abstinence from both bingeing and vomiting. There was no significant difference in final outcome between the original treatment groups. The numbers in remission in each of the original treatment groups were 7 (23%) for the waiting-list, 7 (22%) for minimal guidance, 6 (21%) for telephone guidance and 7 (23%) for face-to-face guidance. Moreover, the total numbers of clinical contacts were similar for the different groups. However, the treatment careers of the patients after the first 4 months differed between the groups not only in terms of drop-out rate but also in the type of sessions received. Those in the face-to-face guidance group received more additional sessions of guided self-help and less full therapy. On a group basis, the investment of 10.7 clinical contacts had been necessary to produce each patient abstinent at 12 months in the waiting-list group, compared with 12.9 for the minimal guidance group, 10.1 for the face-to-face guidance group and 9.5 for the telephone guidance group. Again, there was no significant difference between the groups. Neither eating disorder diagnosis at the outset nor the use of anti-depressant drugs predicted outcome at either 4 or 12 months.
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DISCUSSION |
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Is guidance over the telephone as useful as that given
face-to-face?
Overall, the study provides substantial evidence for the effectiveness of
self-help with face-to-face guidance. On an intention-to-treat analysis, only
face-to-face guidance was significantly better than the other interventions.
However, telephone guidance does show promise. There was a tendency for more
patients who received face-to-face guidance to achieve important improvement
compared with those receiving telephone guidance, although with the more
stringent criterion of remission they performed equally. Telephone guidance
might be useful when face-to-face contact would be difficult to arrange, for
instance in rural services where patients or therapists might have to travel
long distances. This result adds to preliminary work suggesting a role for
treatment delivered over the telephone
(Wells et al, 1997).
It is possible that other technologies such as e-mail or internet chat rooms
might be used in a similar fashion
(Robinson & Serfaty, 2001; Zabinski et al,
2001).
Are the results generalisable?
There are plausible reasons why the present results might have either
underestimated or overestimated the benefits of guided selfhelp. The trial
might have produced better than expected effects because the guidance was
given by nurse therapists experienced in the treatment of people with eating
disorders. Such experienced clinicians might have achieved better results than
those with less expertise. However, they confined themselves to helping the
patients to persevere in using the book that formed the core of the treatment.
Similar results would therefore probably be obtainable with less experienced
therapists.
The setting of the study in a specialist secondary eating disorders service might have led to some underestimation of the potential benefits of guided self-help. In such a specialised setting, many of the patients might have been expecting rather more elaborate therapy and, furthermore, they were treated within a programme where they knew that they would be offered such therapy later if they required it. This expectation in this setting might have disadvantaged the guided self-help intervention. It is plausible that better results might be obtained in less specialised settings, such as primary care, where a modest intervention might be more valued. Furthermore, it is possible that the case mix included a greater proportion of more severe or treatment-resistant cases than would be typical in some other settings such as primary care. However, all of the patients were from a defined catchment area and nearly all were referred directly from primary care. This is typical of the Leicester Eating Disorders Service, but different from some other specialist services that accept referrals mainly on a tertiary basis.
Was the guidance optimal?
This study used only four sessions of guidance spread out over 4 months.
Better results might be obtained with more sessions, or with a different
distribution of sessions: clustering of the sessions early in treatment might
have been preferable. In practice, where the difficulty of provision is not
the lack of overall clinician time but rather the lack of specially trained
clinicians, it may well be rational to offer many more guidance sessions. To
date there has been no direct comparison of full manual-based
cognitive-behavioural therapy with a similar number of sessions of guided
self-help delivered by therapists without specialist training in the
treatment. A study using trained therapists showed no clear difference between
full therapy and guided self-help (Thiels
et al, 1998). However, it could well be that guided
self-help with such substantial guidance might approach the efficacy of full
therapy delivered by a specially trained therapist. Furthermore, the
experience of providing the guidance would be likely to increase the special
competence and confidence of any otherwise experienced clinician delivering
the treatment.
Guided self-help as part of a stepped care programme
The most rational use of guided self-help may be as a first step in a
stepped care arrangement. Within stepped care, more elaborate, expensive or
scarcer treatments are reserved for those who fail to respond to lesser
treatments (Fairburn & Peveler,
1990). Such schemes seem to be rational and to promise an
efficient use of resources, although there is as yet little evidence that this
is so in practice. Indeed, it remains plausible that obliging all patients to
undergo lesser treatments before they have a chance to receive more major
interventions might even be wasteful of resources. The design of the present
study mimics some of the features of a stepped care approach. Most patients
received a lesser treatment rather than being offered full therapy. Except for
those allocated to the waitinglist condition, only those who failed to respond
to self-help with minimal guidance or guided self-help were offered full
therapy - or further guided self-help - according to their degree of
continuing symptoms.
In this study the total amount of clinical contact and the final results were similar for the different treatment conditions. These results do not support the idea that the use of a stepped care approach within secondary care lessens the overall number of clinical contacts required to achieve each patient in remission 1 year after first assessment. However, there could still be some savings in practice. Those who had guided self-help would have tended to have shorter sessions and their provision would tend to be less demanding of therapeutic skill. Furthermore, some patients did achieve lasting remission with guided self-help. Where skilled therapists are in short supply, it might well be rational for their time to be spent with those people who have not responded to guided self-help.
One criticism of stepped care programmes is that they might lead some patients who could have responded to full treatment to drop out before they have had an opportunity to receive it. It is reassuring to note that those who received guided self-help dropped out of contact less than those who had received self-help with minimal guidance or had been obliged to wait for any treatment. They did not seem to be put off by the nature of their initial contact.
Taken together, the present results suggest that guided self-help might well be a useful and cost-effective first response to people presenting with bulimic disorders in secondary care, especially where the alternative is a long wait for full therapy. It might also be offered in primary care. Indeed, the optimal place for guided self-help within a rational overall response to bulimic disorders may well be in primary care and similar settings.
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Clinical Implications and Limitations |
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LIMITATIONS
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ACKNOWLEDGMENTS |
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REFERENCES |
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Received for publication September 4, 2001. Revision received April 19, 2002. Accepted for publication May 15, 2002.
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