Effects of Mindfulness Therapy in Patients With Acromegaly and Cushing
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Patient Satisfaction
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
Sixty patients with acromegaly, (30 in Spain and 30 in Italy) and 60 patients with Cushing syndrome (30 in Spain and 30 in Italy), who are visited in the Endocrinology services of the Hospital de la Santa Creu i Sant Pau, Barcelona and Papa Giovanni XXIII in Bergamo will participate in the study. In...
Sixty patients with acromegaly, (30 in Spain and 30 in Italy) and 60 patients with Cushing syndrome (30 in Spain and 30 in Italy), who are visited in the Endocrinology services of the Hospital de la Santa Creu i Sant Pau, Barcelona and Papa Giovanni XXIII in Bergamo will participate in the study. In each center there will be 30 patients for each pathology (15 will participate in the Mindfulness intervention group and 15 will receive the usual treatment). Inclusion criteria: 1) age between 18 and 70 years, 2) diagnosis of acromegaly, 3) diagnosis of Cushing's syndrome, 4) patients with controlled disease, 5) not currently participating in any other clinical study. Exclusion criteria: 1) physical illnesses or comorbidity of serious mental illness that impede the practice of Mindfulness, 2) Patients who for cognitive, neurological or psychiatric reasons could not follow the sessions 3) Patients who do not accept signing the informed consent 4) Patients with Cushing's syndrome or active acromegaly, 5) Simultaneous participation in another clinical study. Patients who meet the inclusion / exclusion criteria will be invited to participate in the study. The Patient Information Sheet (HIP) and Informed Consent (CI) will be provided. There will be three evaluation visits (pre and post intervention, and 6 months after the intervention) in which the participants must complete different questionnaires and scales. Participants will be invited to keep a daily practice log, and will be required to complete the assigned daily meditation practices for the 8-week program. Demographic and clinical variables (collected from the medical history) will be included. Patients will also have their blood pressure taken before and after each session. Questionnaires: Quality of Life: AcroQoL (patients with acromegaly), CushingQoL (patients with Cushing syndrome) Mood: Hospital Anxiety and Depression Scale (HADS) Sleep: Pittsburgh Sleep Quality Index Pain: McGill Pain Questionnaire Self Compassion Scale (SCS) Life satisfaction scale (SWLS)
Tracking Information
- NCT #
- NCT04420000
- Collaborators
- A.O. Ospedale Papa Giovanni XXIII
- Consorcio Centro de Investigación Biomédica en Red, M.P.
- Investigators
- Principal Investigator: Eugenia Resmini, MD, PhD Ciberer and IIB Sant Pau