Résumé :
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Objective: To prospectively evaluate the psychological impact of the participation in a clinical trial on patients with late-onset Pompe Disease. Method: From the moment of the inclusion and until the end of the trail at 18 months: we assessed every 3 months the psychological status of 10 patients who have been included in a placebo-controlled study of enzyme replacement therapy. Assessment: a) Open interviews were conducted by psychologists to qualitatively assess the impact of the clinical trial on the patient’s personal, marital and socio-professional life. b) Mood and anxiety were assessed with Self-report scales: Beck Depression Inventory, Beck Hopelessness Scale (B.H.S) and State and Trait Anxiety Inventory of Spielberger (S.T.A.I. I and II). c) Impact of the clinical trial and coping were evaluated with Impact of Event Scale (I.E.S) and the IPC scale (Internal, Powerful others, Chance) of Levenson. d) Quality of life and social adjustment were assessed with Whoqol-26 and Social Adjustment Scale in self report (S.A.S S-R). Preliminary and partial results: Throughout the trial mean scores of depression and anxiety-state improved. Quality of life and social adjustment were conserved. Patients privileged coping strategies focused on internal factor. Discussion: According to the preliminary results, there is no negative impact of participation in clinical trial on psychological status, moreover some psychological dimensions improved. We can explain that by two features: a) The medical team offered an enough secure and supportive environment during the trial. b) Participation in a trial has an influence on patient’s subjective position in front of their disease: it gives them a sense of having an active part in medical progress. For patients who are now under treatment (8 patients), the psychological assessment has to be continued in front of weight of treatment, involving a “medicalisation of their existence”.
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