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Institute of Psychiatry, London, UK
Institute for Research and Development, Colombo, Sri Lanka
Institute of Psychiatry, London, UK
Correspondence: Dr A. Sumathipala, Section of Epidemiology, Institute of Psychiatry, De Crespigny Park, London SE5 8AF, UK. Email: spjuats{at}iop.kcl.ac.uk
None. Funding detailed in Acknowledgements.
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMethodResultsDiscussionACKNOWLEDGMENTSREFERENCES |
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A pilot trial in Sri Lanka among patients with medically unexplained symptoms revealed that cognitive–behavioural therapy (CBT) administered by a psychiatrist was efficacious.
Aims
To evaluate CBT provided by primary care physicians in a comparison with structured care.
Method
A randomised control trial (n=75 in each arm) offered six 30 min sessions of structured care or therapy. The outcomes of the two interventions were compared at 3 months, 6 months, 9 months and 12 months.
Results
In each arm, 64 patients (85%) completed the three mandatory sessions. No difference was observed between groups in mean scores on the General Health Questionnaire or the Bradford Somatic Inventory, or in number of complaints or patient-initiated consultations at 3 months. For both groups, all outcome measures improved at 3 months, and remained constant in the follow-up assessments.
Conclusions
Cognitive–behavioural therapy given by primary care physicians after a short course of training is no more efficacious than structured care. Natural remission is an unlikely explanation for improvements in people with chronic medically unexplained symptoms, but lack of a ‘treatment as usual’ arm limits further conclusions. Further research on enhanced structured care, medical assessment and structured care incorporating simple elements of CBT principles is worthy of consideration.
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMethodResultsDiscussionACKNOWLEDGMENTSREFERENCES |
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Medically unexplained symptoms have a similar prevalence and consequences across widely different cultural settings.19 In Sri Lanka, patients with such symptoms were compared with other primary care attenders,13 using the 30-item General Health Questionaire (GHQ–30).20 The prevalence ratio was 2.38 (95% CI 1.78–3.18) and the mean duration of illness was 39 months. Symptoms were not relieved in 72% of these patients in spite of 17 visits to different categories of doctor of their choice per year, compared with 4 visits per year in the control group.
A pilot randomised controlled trial preceding this study to test the effectiveness of an intervention based on CBT principles is the only published example of such an evaluation from a low- to middle-income country.14 The results of the pilot study indicated that brief CBT carried out by a psychiatrist in a primary care setting was efficacious compared with treatment as usual in reducing symptoms (difference in symptom count=2.3, 95% CI 0.85–3.7, P=0.001), psychological morbidity (GHQ score difference=4.1, 95% CI 0.5–7.6, P=0.04) and consultation frequency (difference=4.8, 95% CI 1.3–8, F=9.1, P=0.004). However, Sri Lanka has only 1.3 psychiatrists per million people.21 The larger trial described here tests the same CBT intervention in more pragmatic circumstances, delivered by primary care physicians. The pilot trial, with treatment as usual as its control condition, was open to the criticism that the treatment effect might have been linked to non-specific elements, rather than being a specific effect of CBT. Therefore, we replaced treatment as usual by structured care, offering sessions with similar duration, frequency and attention given by doctors similar to those providing CBT. We tested the hypothesis that for patients with medically unexplained symptoms attending a general out-patient clinic, would be more efficacious than structured care.
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Method |
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TOPABSTRACTINTRODUCTIONMethodResultsDiscussionACKNOWLEDGMENTSREFERENCES |
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Setting and participants
The trial was conducted in a general out-patient clinic at Sri
Jayewardenepura General Hospital, Colombo, where patients initiate their own
visits without prior appointments. The clinic is a primary care facility with
eight doctors, and patients use it as the first point of contact for
healthcare. Consecutive attenders were screened to identify those meeting the
inclusion criteria for the trial.
Inclusion and exclusion criteria
Patients aged 16–65 years who had had five or more medically
unexplained symptoms for a period of at least 6 months were eligible for
inclusion. Symptoms of shorter duration are particularly likely to resolve
spontaneously, therefore such patients were
excluded.23
Medically unexplained symptoms were defined on the basis of at least one of
the following:
Symptoms (e.g. pain) experienced at different anatomical sites were counted as separate symptoms, as were different symptoms at the same anatomical site. Those with dementia, psychosis or alcohol dependence were excluded from the trial, as were those currently receiving treatment for a psychiatric disorder.
Recruitment procedures
Recruitment took place among consecutive out-patient department attenders.
The eight primary care physicians were instructed verbally as well as by a
printed A4 sheet on how to recognise medically unexplained symptoms, and
identified patients with repeated consultations for such symptoms. These
patients were referred to the trial coordinator (A.S.) and the trial physician
(S.S.), who made independent assessments to establish eligibility, each
administering two open-ended questions (‘What are your symptoms?’
‘Are there any other symptoms/problems?’) to elicit the number of
symptoms and the number of visits over the previous 6
months.14 A
comprehensive physical examination was carried out by S.S., who also reviewed
previous laboratory investigation results. Patients with overt disease were
excluded. If both A.S. and S.S. agreed that the patient was eligible to be
recruited, non-clinical research assistants obtained informed consent.
Patients who refused or who did not fulfil the inclusion criteria were
referred back to the primary care doctor.
Sample size calculation
The sample size calculation was based on the assumption that only a
relatively large effect size associated with the intervention was likely to
influence policy. The priorities for hard-pressed primary care services in Sri
Lanka remain infectious disease, heart disease, hypertension and diabetes.
Although repeated attendance of patients with multiple symptoms is a
well-recognised problem, a psychological intervention would have to be highly
efficacious to stand a realistic chance of being adopted. Therefore the sample
size was set at 55 in each group to confer 80% power at 5% significance of
detecting a true effect size of 0.5 (generally designated as a moderate
effect) for detectable differences in mean scores on the primary outcome
measure (the GHQ score) between the two groups. Allowing for 30% attrition, 72
patients were needed in each group, rounded to 75 in each arm. In the pilot
trial a large effect size was observed when the psychiatrist provided CBT. We
assumed such a larger effect size was unrealistic when primary care doctors
provided the therapy.
Randomisation
The six doctors comprised four who were entirely based in the out-patient
department and two who were employed in the hospital but also worked as
general practitioners in the community. The doctors were allocated at random
to deliver CBT or structured care, in such a way that three doctors were
allocated to each intervention, with two hospital-based physicians and one
general practitioner in each group.
Trial participants were first randomised to the two intervention groups using a random permuted block design, with a block size of four. Next, participants were randomly allocated to one of the three doctors selected to deliver the intervention to which they had been allocated. Randomisation codes were generated by a statistician in the UK and passed on to the independent epidemiologist (M.R.N.A.) in Sri Lanka, who executed the random allocation of treatment condition.
Throughout the trial both the physician (S.S.) and the research assistants for the project remained masked to the group status of the patients. Details of allocation of all patients were concealed from them until the end of the trial. The research assistants did not know which primary care doctors provided which treatment. Neither the primary care doctors who delivered the interventions nor the patients who received them could be masked to their allocation because of the nature of the interventions. Similarly, the trial coordinator (A.S.) was not masked to the group status. However, he was not involved in registration, randomisation, treatment allocation, data collection or main outcome analysis.
Trial procedures
The primary care physician was responsible for arranging the subsequent
treatment sessions. An administrator facilitated the appointments and
follow-up assessments. The full baseline assessment was repeated 3 months, 6
months and 12 months post-baseline. A part assessment was done at 9 months to
maintain continuity. Patients who were not present for re-assessments were
sent reminders by post or were contacted over the telephone. If they were
unable to attend, assessments were carried out at the person’s home.
Assessments and instruments
The trial physician (S.S.) and the trial coordinator (A.S.) ascertained the
number of medically unexplained symptoms using the procedure described above.
Participants also completed the following clinical assessments.
General Health Questionnaire
The GHQ–30 is a scalable measure of psychological morbidity, and was
used as a continuous variable because it is useful for comparisons across
groups.24 This
questionnaire has been translated into Sinhala,
validated,2,25,26
and used successfully in previous studies in primary
care.13,14
Bradford Somatic Inventory
The BSI is a structured assessment of the presence and the severity of 21
commonly occurring somatic
symptoms.22 The
symptoms were derived from psychiatric case-notes of British patients of
indigenous and Pakistani origin, with clinical diagnoses of anxiety,
depression, hypochondriasis and somatoform disorders. It has been validated in
Britain and Pakistan, and used widely in the detection of psychiatric
disorders among Asian patients presenting with somatic symptoms. Symptoms are
coded as absent (0), or present on less than 15 days (1) or more than 15 days
(2) in the past month. Possible scores range from 0 to 42. The BSI was also
adapted and validated for Sri Lanka by
A.S.27
Interventions
Assessment as part of the interventions
The Semi-Structured Explanatory Model Interview (SEMI) developed by Lloyd
et al is a framework for eliciting salient information relevant to
the management of medically unexplained
symptoms.28 The
SEMI was part of both the CBT and the structured care intervention. Using the
SEMI for exploration of the patient’s and clinician’s explanatory
model is valuable in developing culturally appropriate
interventions.29
This instrument uses open-ended questions to elicit patients’
explanatory models. It generates data on the respondents’ assumptions,
beliefs, thoughts about their illness and its causes, and fears about their
future. It includes details of healthcare utilisation, and patients’
expectations of treatment and satisfaction with their care. Both groups were
interviewed at baseline by A.S. using the SEMI, and its case vignettes and
information were passed on to all the primary care physicians with the
case-notes. In addition, the physicians providing CBT received a summary and a
formulation based on SEMI findings prepared by A.S. and were trained to use
this information to inform the strategy for their CBT intervention.
Two diaries were issued to every participant for the period of the intervention. The first was for any doctor consulted over the period of the trial to record consultations, symptoms, investigations and treatment. The other diary was for participants to record their own symptoms, associated cognitions and behaviours. For participants in both study groups the diaries afforded a mechanism for expressing distress. Information in the diary was available to the physicians in both study arms. In the CBT intervention the doctors were trained to use the participants’ diaries to identify dysfunctional cognitions and to monitor symptoms. The doctors who provided structured care were not given training as to the purpose or potential therapeutic use of the diaries.
Cognitive–behavioural therapy
The intervention strategy was based on the therapy developed and manualised
for the previous pilot
trial.14,30,31
It aimed to contain the patient’s help-seeking behaviour by offering
structured regular visits to one health professional, thus reducing
unstructured visits to different practitioners who might reinforce
dysfunctional cognitions and behaviours through inappropriate advice and
investigations. The treatment was based on the principles of CBT and
reattribution
technique,32–34
modified to suit the local sociocultural context. Where possible, the support
of the spouse or other close relative was elicited to discourage inappropriate
discussions with ill-informed relatives and friends, who could reinforce the
patient’s preoccupation with fears of serious
illness.33 A
treatment manual was used to standardise the
intervention.30 In
the pilot study we offered six therapy sessions; however, 90% of the
participants who attended three or more sessions stayed in the study, improved
and also were available for outcome assessment. Hence, in this study, CBT was
offered in three half-hourly structured sessions over the 3 weeks following
the baseline assessment; these sessions were mandatory and those who did not
complete them were considered non-adherent. A further three optional
fortnightly follow-up sessions were offered.
The CBT training was a short course consisting of five sessions covering the basis of medically unexplained symptoms; the relevance of the explanatory model, elicited by the SEMI, to the CBT model of such symptoms; and the CBT treatment approach. Training was accomplished through lectures by P.d.S. and A.S., supplemented by case vignettes and role-play of therapeutic sessions by simulated patients based on case scenarios from the pilot trial, all with reference to the intervention manual. To ensure that CBT was delivered appropriately, the three doctors in the intervention arm received regular supervision from A.S.
Structured care
The components of the treatment packages and follow-up assessments received
by the two groups differed in only one respect: participants in the structured
care group did not receive CBT components detailed in the
manual.30 The
structured care also consisted of six half-hour appointments with one primary
care physician. As in the CBT intervention, the first three weekly sessions
were mandatory and the next three fortnightly sessions were optional. Another
similarity was the use of diaries, which provided a mechanism for expressing
distress. The three physicians were free to manage the patients as they wished
within the sessions. No training or supervision was provided for these
doctors, and the intervention was not manualised.
Follow-up
At the end of the intervention, participants in both groups received a
written summary of their history and the intervention and were asked to
produce this if they consulted any other doctor within the next 12 months. No
further appointment for CBT or structured care was booked, but participants
had the option of visiting the doctor who offered the intervention or to visit
any other doctor of their choice. This is the usual practice in Sri Lanka, as
a formal general practice system does not exist. However, an administrator
facilitated the appointments for follow-up outcome assessments.
Statistical analysis
An interim analysis was not done. M.D., who was masked to randomised group
allocation, analysed the scores from the four fixed time points (3 months, 6
months, 9 months and 12 months after randomisation) using a mixed effects
model. We included as fixed effects group allocation, baseline score, time,
and the interaction of group and time. Time was coded as months after the
3-month time point, giving values of 0, 3, 6 and 9, so that in the presence of
the interaction the effect of group represents the difference at 3 months. We
included the patient as a random effect. We also fitted models with a random
effect of time, with various covariance patterns, with treating doctor as an
effect, and pattern mixture models to allow for the different drop-out
patterns. We report here the simpler models as they fit as well as any of the
more complex ones. We also examined model residuals. A mixed effects model was
used as this enables effective use of all the information even from
participants who had some missing scores. We used r for the
analysis,35 with
the nlme package for fitting the mixed effects
models.36
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Results |
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TOPABSTRACTINTRODUCTIONMethodResultsDiscussionACKNOWLEDGMENTSREFERENCES |
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Uptake of the interventions
In each arm, 64 participants (85%) completed the three mandatory sessions.
Uptake of optional sessions was low; four sessions out of 20 (27%) in the CBT
group compared with 14 (19%) in the structured care group, and five sessions
out of 15 (20%) in the CBT group compared with 13 (17%) in the structured care
group. Significantly, uptake of all six sessions was higher for the latter
group (37%, n=28) than for the CBT group (20%, n=15;
2=4.69, P=0.03). In contrast, a higher percentage of
those allocated to structured care did not attend any of the sessions,
mandatory or optional (9% v. 3%; 2=1.89,
P=0.17).
Availability for follow-up assessment
Every attempt was made to follow-up all 150 participants regardless of
whether they completed the treatment. Availability of participants at each of
the follow-up assessments is presented in
Fig. 1 and in
Table 2. The proportion
attending all four follow-up assessments was higher among those allocated to
CBT, but this was not statistically significant. The 24 participants (16%) who
missed all four follow-up assessments could not be traced to the original
addresses, directly refused, did not engage any further or had gone abroad.
There were no reported deaths.
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Relationship between treatment completion and availability at follow-up
The majority (n=13) of the 22 patients who did not complete the
three mandatory sessions (protocol violators) were also lost to follow-up and
did not attend any of the four follow-up assessments. However, 7 of the
remaining 9 protocol violators were available for all four follow-up
assessments. Of those who completed the three mandatory sessions
(n=64 in each arm), 53 (83%) in the CBT group and 47 (73%) in the
structured care group were available for all four follow-up assessments
(RR=1.1, 95% CI 0.9–1.4; 2=1.1, P=0.29). Those
who did not receive a sufficient dose of treatment (three mandatory sessions)
were more likely to be lost to follow-up.
Outcomes
Table 3 provides the
coefficients and 95% confidence intervals for the mixed effects models outcome
scores at 3 months, 6 months, 9 months and 12 months after baseline.
Coefficients were estimated for the fixed effects of group allocation,
baseline score, time and the interaction of group and time. In the presence of
an interaction the group coefficient represents the difference at 3 months.
For both groups, mean scores for all outcomes declined sharply from baseline
to the first 3-month outcome assessment, and then remained essentially
constant over time thereafter (Fig.
2). As can be seen from the coefficients, none of the group
differences at 3 months was statistically significant, nor was there any
difference in the effect of time (after the 3-month outcome) between groups
(i.e. none of the interactions between time and group was statistically
significant). Given the observed changes in outcome over time, we calculated,
post hoc, the effect sizes for the change scores between baseline and
3 months for each outcome, with each randomised allocation. These indicated
substantial and statistically significant reductions from baseline
(Table 4).
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Discussion |
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TOPABSTRACTINTRODUCTIONMethodResultsDiscussionACKNOWLEDGMENTSREFERENCES |
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Potential explanations of these findings are natural remission of symptoms in both groups and higher baseline scores regressing to the mean. However, in a recent cohort study of patients presenting with physical symptoms to primary care, those with medically unexplained symptoms were unlikely to improve at 5 years if they initially had poor functioning, longer duration of symptoms and illness worries.2 Similarly, in a 10-year follow-up study of patients with chest pain who had negative coronary angiography, 75% remained symptomatic and disabled.37 Natural remission or higher baseline scores regressing to the mean are therefore unlikely to be the most plausible explanations, because patients in this trial had a mean duration of symptoms of 42 months, poor functioning (95% requiring one or more assistants for help in their day-to-day activities) and considerable illness worries (harboured by 95%).
With the benefit of hindsight, the lack of a trial arm allocated to treatment as usual is an important disadvantage, as the significant change scores for both groups cannot be directly compared with currently available treatment in Sri Lanka. Such treatment is usually symptomatic, with no structured care, so that these patients make around seven visits to 4–10 different categories of doctors of their choice over 6 months.14
Assuming both interventions to be equally efficacious, lack of a difference between the groups at follow-up should not be interpreted exclusively as equal effect of both treatments, because it might be due to a type II error, resulting from inadequate power to detect small differences. Hence, our findings need to be interpreted cautiously. The earlier pilot trial, conducted in a similar setting on a smaller sample with similar characteristics,14 indicated a substantial and statistically significant treatment benefit associated with CBT delivered by a psychiatrist, when compared with treatment as usual (no structured care), using for the most part the same outcomes studied in this trial. The characteristics of the pilot trial and the present trial are presented in Table 5, because the setting, recruitment, inclusion criteria, assessment instruments (including the use of SEMI) and the outcome measures were the same. Although a direct comparison cannot be made between the two trials, the effect sizes associated with CBT on primary and secondary outcomes are similar in both, despite the CBT intervention being administered by primary care physicians in one study and by an experienced psychiatrist in the other. Indeed, the effect on GHQ–30 and BSI scores was larger for the physician-administered CBT. However, the effect sizes associated with structured care given by primary care physicians are similar to those achieved by the CBT intervention in both the pilot trial and the present trial, and are much superior to treatment as usual in the pilot trial. The differences between the findings of the pilot trial and the present trial are therefore more parsimoniously explained by the relative effectiveness of structured care than by an ineffectiveness of CBT when administered by primary care doctors following minimal training. Alternatively, the failure of CBT to show a clear superiority could be due to insufficient treatment intensity or duration (i.e. dosage) or an inadequacy of competency (i.e. duration of training or background knowledge). Also, there was no assessment of CBT fidelity to protocol. The short training provided for doctors might have resulted in a technique-based competency with little understanding of cognitive and behavioural sciences. This might have resulted in a lack of flexibility in treatment to produce the maximum treatment effect. Alternatively, primary care physicians might not be good cognitive–behavioural therapists. In a randomised controlled trial on chronic fatigue, CBT given by general practitioners did not have any effect compared with the control group (who did not have CBT).38 In a systematic review there was no strong evidence for the effectiveness of psychosocial interventions by general practitioners.39 Another possibility is that CBT is not indicated. Unexplained symptoms may be puzzling and distressing, and the patient might simply need the doctor to be honest about uncertainty and provide simple reassurance, without attempting to change cognitions through CBT.
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Hence, the lack of statistically significant difference between the two arms of our study should not undermine the clinical importance of its findings, in particular the potentially positive impact of structured care. We cannot directly establish that such care was more efficacious than treatment as usual. However, the comparison of effect sizes between the pilot trial and this study suggests that this is a possibility. Further development of structured care, as a less onerous and cheaper but possibly equally effective alternative to CBT,40 requires some consideration of the elements that were common to both the interventions provided in this trial. These were as follows.
The use of placebo medication was a unique component in the structured care intervention.
Limitations
Contamination (or a spillover effect) of the interventions might have
occurred given that the doctors administering both worked in the same primary
care centre. Doctors providing structured care might have picked up on
cognitive–behavioural techniques from the doctors who provided CBT. Most
of the doctors who referred patients for the trial also treated them. This
might have biased the inclusion in such a way that only highly motivated
patients or patients fitting the treatment were recruited. However, this
selection bias would not affect the comparison between the two interventions,
but could contribute to the high effect sizes of both interventions.
Generalisability to routine primary care may be limited by recruitment
confined to chronically ill patients with multiple complaints and repeated
visits enrolled from a single clinic. Similarly, even if both interventions
were equally efficacious, they were relatively demanding (three to six 30 min
sessions) and therefore of questionable generalisability.
Study implications
Either CBT or structured care may improve symptoms of patients with chronic
medically unexplained symptoms and frequent attendance to many different
healthcare providers. These interventions were not studied directly against
treatment as usual in this trial, but the observed change was larger than that
seen in a previous trial and deserves further study in comparison with usual
treatment. Treatment of patients with medically unexplained symptoms is a
complex process, consisting of different components, which may act both
independently and
interdependently.43
However, the active component may not be easily defined. Therapist and patient
characteristics, delivery, frequency and timing of the trial procedures;
recruitment into a trial per se, the information leaflet, the consent
process, non-specific effects of structured appointments and the regular
structured follow-up assessment all may be active ingredients.
Findings of this trial support the importance of evaluating the ‘effectiveness of medical assessments augmented by inclusion of proven cognitive–behavioural elements’.40 Hence, future research should consider enhanced structured care; medical assessment and structured care incorporating simple elements of CBT principles that can be used by doctors without specific training or CBT skills.
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ACKNOWLEDGMENTS |
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REFERENCES |
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TOPABSTRACTINTRODUCTIONMethodResultsDiscussionACKNOWLEDGMENTSREFERENCES |
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2 Jackson JL, Passamonti M. The outcomes among patients presenting in primary care with a physical symptom at 5 years. J Gen Intern Med 2005; 20: 1032 –7.[CrossRef][Medline]
3 Kroenke K, Price RK. Symptoms in the community: prevalence, classification, and psychiatric co-morbidity. Arch Intern Med 1993; 153: 2474 –80.[Abstract]
4 Henningsen P, Zimmermann T, Sattel H. Medically unexplained
physical symptoms, anxiety, and depression: a meta-analytic review.
Psychosom Med 2003;
65: 528
–33.
5 Toft T, Fink P, Oernboel E, Christensen K, Frostholm L, Olesen F. Mental disorders in primary care: prevalence and co-morbidity among disorders. Results from the Functional Illness in Primary care (FIP) study. Psychol Med 2005; 35: 1175 –84.[CrossRef][Medline]
6 Wessely S. The rise of counselling and its effect on utilization of
health care resources. BMJ 1996;
313: 158
–60.
7 Mayou R. Medically unexplained physical symptoms. BMJ 1991; 303: 534 –5.[Medline]
8 Kroenke K, Spitzer RL, Williams JB, Linzer M, Hahn SR, deGruy FV, Brody D. Physical symptoms in primary care: predictors of psychiatric disorders and functional impairment. Arch Fam Med 1994; 3: 774 –9.[Abstract]
9 Smith RC, Gardiner JC, Lyles JS, Sirbu C, Dwamena FC, Hodges A,
Collins C, Lein C, Given CW, Given B, Goddeeris J. Exploration of DSM–IV
criteria in primary care patients with medically unexplained symptoms.
Psychosom Med 2005;
67: 123
–9.
10 Feder A, Olfson M, Gameroff M, Fuentes M, Shea S, Lantigua RA,
Weissman MM. Medically unexplained symptoms in an urban general medicine
practice. Psychosomatics 2001;
42: 261
–8.
11 Nease DE, Volk RJ, Cass AR. Does the severity of mood and anxiety symptoms predict health care utilization? J Fam Pract 1999; 48: 769 –7.[Medline]
12 Creed F, Barsky A. A systematic review of the epidemiology of somatisation disorder and hypochondriasis. J Psychosom Res 2004; 56: 391 –408.[CrossRef][Medline]
13 Sumathipala A. Psychiatric disturbance in patients with multiple complaints and/or repeated consultations. MD Thesis, Postgraduate Institute of Medicine, University of Colombo, Sri Lanka, 1990 .
14 Sumathipala A, Hewege S, Hanwella R, Mann AH. Randomised controlled trial of cognitive behaviour therapy for repeated consultations for medically unexplained complaints: a feasibility study in Sri Lanka. Psychol Med 2000; 30: 747 –57.[CrossRef][Medline]
15 Sumathipala A. CBT for patients with multiple complaints and/or repeated consultations. PhD Thesis, University of London, 2004 .
16 O’Malley PG, Jackson JL, Santoro J, Tomkins G, Balden E, Kroenke K. Antidepressant therapy for unexplained symptoms and symptom syndromes: a critical review. J Fam Pract 1999; 48: 980 –93.[Medline]
17 Kroenke K Swindle R. Cognitive–behavioral therapy for somatization and symptom syndromes: a critical review of controlled clinical trials. Psychother Psychosom 2000; 69: 205 –15.[CrossRef][Medline]
18 Sumathipala A. What is the evidence for the efficacy of treatments
for somatoform disorders? A critical review of previous intervention studies.
Psychosom Med 2007;
69: 889
–900.
19 Gureje O, Simon GE, Ustun TB, Goldberg DP. Somatization in cross-cultural perspective: a World Health Organization study in primary care. Am J Psychiatry 1997; 154: 989 –95.[Abstract]
20 Goldberg D, Blackwell P. Psychiatric illness in general practice: a detailed study using a new method for case identification. BMJ 1970; 2: 439 –44.
21 World Health Organization. Department of Mental Health and Substance Abuse Mental Health Atlas. WHO, 2005 .
22 Mumford DB, Bavington JT, Bhatnagar KS, Hussain Y, Mirza S, Naraghi
MM. The Bradford Somatic Inventory. A multi-ethnic inventory of somatic
symptoms reported by anxious and depressed patients in Britain and the
Indo-Pakistan subcontinent. Br J Psychiatry 1991; 158: 379
–86.
23 Craig TK, Boardman AP, Mills K, Daly-Jones O, Drake H. The South
London Somatisation Study. 1: Longitudinal course and the influence of early
life experiences. Br J Psychiatry 1993;
163: 579
–88.
24 Odell SM, Surtees PG, Wainwright NW, Commander MJ, Sashidharan SP.
Determinants of general practitioner recognition of psychological problems in
a multi-ethnic inner-city health district. Br J
Psychiatry 1997; 171: 537
–41.
25 De Silva N, Samarasingha D. Acceptance of a psychiatric screening questionnaire by general practice attendees. Ceylon Med J 1990; 35: 105 –8.[Medline]
26 Samarasingha D. Recognition and management of functional complaints. Ceylon Med J 1991; 36: 23 –7.[Medline]
27 Sumathipala A, Murray J. New approach to translating instruments for cross-cultural research: a combined qualitative and quantitative approach for translation and consensus generation. Int J Methods Psychiatr Res 2000; 9: 87 –95.[CrossRef]
28 Lloyd KR, Jacob KS, Patel V. The development of The Short Explanatory Model Interview (SEMI) and its use among primary care attenders with common mental disorders. A preliminary report. Psychol Med 1998; 28: 1231 –7.[CrossRef][Medline]
29 Bhui K, Bhugra D. Explanatory models for mental distress:
implications for clinical practice and research. Br J
Psychiatry 2002; 181: 6
–7.
30 Sumathipala A, Siribaddana S, Mangava S, De Silva P. Cognitive Behavioural Therapy for Medically Unexplained Symptoms. Forum for Research and Development Publication, Colombo, 2006.
31 Patel V, Sumathipala A. Psychological approaches to somatisation in
developing countries. Adv Psychiatr Treat 2006; 12: 54
–62.
32 Salkovoskis PM. Somatic problems. In Cognitive Behaviour Therapy for Psychiatric Problems: A Practical Guide (eds K Hawton, PM Salkovoskis, J Kirk, DM Clark). Oxford University Press, 1989 .
33 Sharpe M, Peveler R, Mayou R. Invited review – the psychological treatment of patients with functional somatic symptoms. A practical guide. J Psychosom Res 1992; 36: 515 –29.[CrossRef][Medline]
34 Goldberg DP, Gask L, O’Dowd T. The treatment of somatisation: teaching techniques of reattribution. J Psychosom Res 1989; 33: 689 –95.[CrossRef][Medline]
35 Ihaka R, Gentleman R. A language for data analysis and graphics. J Comput Graph Stat 1996; 5: 299 –314.[CrossRef]
36 Pinheiro JC, Bates DM. Mixed-effects Models in S and S-PLUS. Springer, 2000.
37 Potts SG, Bass CM. Psychological morbidity in patients with chest pain and normal or near-normal coronary arteries: a long-term follow-up study. Psychol Med 1995; 25: 339 –47.[Medline]
38 Huibers MJ, Beurskens AJ, Van Schayck CP, Bazelmans E, Metsemakers
JF, Knottnerus JA, Bleijenberg G. Efficacy of cognitive–behavioural
therapy by general practitioners for unexplained fatigue among employees:
randomised controlled trial. Br J Psychiatry 2004; 184: 240
–6.
39 Huibers MJ, Beurskens AJ, Bleijenberg G, van Schayck CP. Psychosocial interventions by general practitioners. Cochrane Database of Systematic Reviews, issue 3, CD003494 . Wiley Interscience, 2007 .
40 Sharpe M, Carson A. Unexplained somatic symptoms, functional
syndromes, and somatization: do we need a paradigm shift? Ann
Intern Med 2001; 134: 926
–30.
41 Price J. Review: antidepressant is effective for clinical
unexplained symptoms and syndromes. Evid Based Ment
Health 2000; 3: 84
.
42 Petrie K, Moss-Morris R, Weinman J. The impact of catastrophic beliefs on functioning in chronic fatigue syndrome. J Psychosom Res 1995; 39: 31 –7.[CrossRef][Medline]
43 Medical Research Council. Framework for Development and Evaluation of RCTs for Complex Interventions to Improve Health. MRC, 2000.
Received for publication July 19, 2007. Revision received February 14, 2008. Accepted for publication February 29, 2008.
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