Effects of Mindfulness Therapy in Patients With Acromegaly and Cushing
NCT ID: NCT04420000
Last Updated: 2023-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2020-09-01
2021-10-01
Brief Summary
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The main objective of the study will be to assess changes in quality of life, mood, chronic pain and sleep after the delivery of a Mindfulness program.
The secondary objectives will be: to evaluate if this program also affects blood pressure, if the changes are maintained six months after treatment and if it determines the decrease in health resources used.
The intervention group will do Mindfulness sessions according to an established protocol of 8 weeks, while the control group will follow the normal clinical routine. The Mindfulness protocol will be carried out in group sessions led by a therapist with experience in mindfulness and compassion, lasting 120 minutes, weekly, which will take place over 8 weeks.
Two separate studies will be done, one for patients with acromegaly which will be the first to take place and then another for patients with Cushing's syndrome.
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Interventional group
Patients having a Mindfulness program
Mindfulness
Mindfulness based programme
Control group
Patients having a routinary managment
Control
Treatment as usual
Interventions
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Mindfulness
Mindfulness based programme
Control
Treatment as usual
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of controlled Cushing syndrome
* Must be able to perform Mindfulness
Exclusion Criteria
* Previous experience with Mindfulness
* Participation in other clinical trials
18 Years
70 Years
ALL
No
Sponsors
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A.O. Ospedale Papa Giovanni XXIII
OTHER
Consorcio Centro de Investigación Biomédica en Red (CIBER)
OTHER_GOV
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Principal Investigators
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Eugenia Resmini, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ciberer and IIB Sant Pau
Locations
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Resmini Eugenia
Barcelona, , Spain
Countries
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Other Identifiers
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IIBSP-MIN-2020-16
Identifier Type: -
Identifier Source: org_study_id
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