Effectiveness of a blended multidisciplinary intervention for patients with moderate medically unexplained physical symptoms (PARASOL): A cluster randomized clinical trial

Abstract

INTRODUCTION: In patients with moderate Medically Unexplained Physical Symptoms (MUPS), interventions focusing on both physical and psychological aspects are recommended. A proactive, blended and integrated physical therapy and mental health nurse intervention (PARASOL) might reduce complaints, stimulate self-management and prevent chronicity. OBJECTIVE: To investigate short- and long-term effectiveness of the PARASOL intervention compared to usual care on subjective symptom impact and quality of life in patients with moderate MUPS. METHODS: We conducted a cluster randomized clinical trial. The 12-week intervention integrated face-to-face sessions with the physical therapist and mental health nurse and access to a web-based program consisting of graded activity, exercises and information modules. Primary outcomes were subjective symptom impact, as registered with the adequate relief question, and quality of life. Secondary outcomes were severity of (psychosocial) symptoms, overall current health, physical behaviour, illness perceptions, and self-management skills. Assessment took place at baseline, after three and twelve months. RESULTS: Compared to usual care (n = 80), the number of patients in the PARASOL intervention (n = 80) that reported adequate short-term relief was higher (31.2% in intervention group vs. 13.7% in control group). On quality of life and secondary outcomes no significant between group differences in short- and long-term were found. CONCLUSIONS: The PARASOL intervention does improve subjective symptom impact of patients with moderate MUPS on short-term. No additional beneficial effects on the other outcomes and the long-term were found.