Abstract
Background
Medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS) are debilitating to patients. As many specific PPS syndromes share common behavioural, cognitive, and affective influences, transdiagnostic treatments might be effective for this patient group. We evaluated the clinical efficacy and cost-effectiveness of a therapist delivered, transdiagnostic cognitive behavioural intervention (TDT-CBT) plus (+) standard medical care (SMC) versus SMC alone for the treatment of patients with PPS in secondary medical care.
Methods
A two-arm randomised controlled trial, with measurements taken at baseline and at 9, 20, 40- and 52-weeks post randomisation. The primary outcome measure was the Work and Social Adjustment Scale (WSAS) at 52 weeks. Secondary outcomes included mood (PHQ-9 and GAD-7), symptom severity (PHQ-15), global measure of change (CGI), and the Persistent Physical Symptoms Questionnaire (PPSQ).
Results
We randomised 324 patients and 74% were followed up at 52 weeks. The difference between groups was not statistically significant for the primary outcome (WSAS at 52 weeks: estimated difference -1.48 points, 95% CI from -3.44 to 0.48, p=0.139). However, the results indicated that some secondary outcomes had a treatment effect in favour of TDT-CBT+SMC with three outcomes showing a statistically significant difference between groups. These were WSAS at 20 weeks (p=0.016) at the end of treatment and the PHQ-15 (p=0.013) and CGI at 52 weeks (p=0.011).
Conclusion
We have preliminary evidence that TDT-CBT+SMC may be helpful for people with a range of PPS. However, further work is required to maximise or maintain effects seen at end of treatment.
Medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS) are debilitating to patients. As many specific PPS syndromes share common behavioural, cognitive, and affective influences, transdiagnostic treatments might be effective for this patient group. We evaluated the clinical efficacy and cost-effectiveness of a therapist delivered, transdiagnostic cognitive behavioural intervention (TDT-CBT) plus (+) standard medical care (SMC) versus SMC alone for the treatment of patients with PPS in secondary medical care.
Methods
A two-arm randomised controlled trial, with measurements taken at baseline and at 9, 20, 40- and 52-weeks post randomisation. The primary outcome measure was the Work and Social Adjustment Scale (WSAS) at 52 weeks. Secondary outcomes included mood (PHQ-9 and GAD-7), symptom severity (PHQ-15), global measure of change (CGI), and the Persistent Physical Symptoms Questionnaire (PPSQ).
Results
We randomised 324 patients and 74% were followed up at 52 weeks. The difference between groups was not statistically significant for the primary outcome (WSAS at 52 weeks: estimated difference -1.48 points, 95% CI from -3.44 to 0.48, p=0.139). However, the results indicated that some secondary outcomes had a treatment effect in favour of TDT-CBT+SMC with three outcomes showing a statistically significant difference between groups. These were WSAS at 20 weeks (p=0.016) at the end of treatment and the PHQ-15 (p=0.013) and CGI at 52 weeks (p=0.011).
Conclusion
We have preliminary evidence that TDT-CBT+SMC may be helpful for people with a range of PPS. However, further work is required to maximise or maintain effects seen at end of treatment.
| Original language | English |
|---|---|
| Journal | Psychological medicine |
| Publication status | Accepted/In press - 21 Apr 2021 |
Keywords
- Persistent physical symptoms
- medically unexplained symptoms
- transdiagnostic
- cognitive behavioural therapy
- secondary medical care
- randomised controlled trial