Background. Research on the management and the outcome of treatment of medically unexplained
symptoms is very limited. Development of simple but effective techniques for treatment and
demonstration of their effectiveness when applied in primary health care are needed.
Methods. A randomized controlled trial was carried out with follow-up assessments at 3 months
after baseline assessments using the Short Explanatory Model Interview (SEMI), General Health
Questionnaire (GHQ-30), Bradford Somatic Inventory (BSI) and patient satisfaction on a visual
analogue scale. The study was carried out in a general out-patient clinic in Sri Lanka.
The intervention group received six, 30 min sessions based on the principles of cognitive behavioural
therapy over a period of 3 months. The control group received standard clinical care.
Results. Eighty patients out of the 110 patients referred, were eligible. Sixty-eight were randomly
allocated equally to the control and treatment groups. All 34 in the treatment group accepted the
treatment offer and 22 completed between three and six sessions. At 3 months, 24 in the treatment
and 21 in the control group completed follow-up assessments. Intention-to-treat analysis revealed
significant differences in mean scores of outcome measures (adjusted for baseline scores) between
control and intervention groups respectively – complaints 6·1 and 3·8
(P = 0·001), GHQ 10·4 and 6·3 (P = 0·04),
BSI score 15·6 and 13·2 (P [les ] 0·01), visits 7·9
and 3·1 (P = 0·004).
Conclusions. Intervention based on cognitive behavioural therapy is feasible and acceptable to
patients with medically unexplained symptoms from a general out-patients clinic in Sri Lanka. It
had a significant effective in reducing symptoms, visits and distress, and in increasing patient