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Effects of Mindfulness Therapy in Patients With Acromegaly and Cushing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04420000
Recruitment Status : Unknown
Verified September 2020 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was:  Recruiting
First Posted : June 9, 2020
Last Update Posted : September 30, 2020
Sponsor:
Collaborators:
A.O. Ospedale Papa Giovanni XXIII
Consorcio Centro de Investigación Biomédica en Red, M.P.
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Description
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Brief Summary:

Randomized, multicenter, international clinical trial (one center in Barcelona and one center in Bergamo, Italy), with exploratory intention.

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.


Condition or disease Intervention/treatment Phase
Patient Satisfaction Behavioral: Mindfulness Other: Control Not Applicable

Detailed 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 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)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Mindfulness Therapy in Patients With Acromegaly and in Patients With Cushing's Syndrome
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Interventional group
Patients having a Mindfulness program
 Behavioral: Mindfulness
Mindfulness based programme
Placebo Comparator: Control group
Patients having a routinary managment
 Other: Control
Treatment as usual


Outcome Measures
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Primary Outcome Measures :
  1. Change in quality of life in patients with acromegaly [ Time Frame: Baseline, post-intervention (8 weeks) ]
    using the Acromegaly Quality of Life Questionnaire (AcroQoL)

  2. Change in quality of life in patients with Cushing's syndrome [ Time Frame: Baseline, post-intervention (8 weeks) ]
    using the Cushing's Quality-of-Life (CushingQOL) questionnaire


Other Outcome Measures:
  1. Change in Pain in patients with acromegaly and Cushing's syndrome [ Time Frame: Baseline, post-intervention (8 weeks) ]
    as evaluated using the McGill Pain Questionnaire

  2. Change in Mood in patients with acromegaly and Cushing's syndrome [ Time Frame: Baseline, post-intervention (8 weeks) ]
    as evaluate using Hospital Anxiety and Depression Scale (HADS)

  3. Change in Sleep in patients with acromegaly and Cushing's syndrome [ Time Frame: Baseline, post-intervention (8 weeks) ]
    as evaluate using Pittsburgh sleep scale

  4. Self compassion in patients with acromegaly and Cushing's syndrome [ Time Frame: Baseline, post-intervention (8 weeks) ]
    as evaluate using Self Compassion Scale (SCS)

  5. Satisfation with life in patients with acromegaly and Cushing's syndrome [ Time Frame: Baseline, post-intervention (8 weeks) ]
    as evaluate using SWLS questionnaire


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of controlled acromegaly,
  • Clinical diagnosis of controlled Cushing syndrome
  • Must be able to perform Mindfulness

Exclusion Criteria:

  • Psychiatric disorders
  • Previous experience with Mindfulness
  • Participation in other clinical trials
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04420000


Contacts
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Contact: Eugenia Resmini, MD, PhD 34935537917 eresmini@santpau.cat

Locations
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Spain
Resmini Eugenia Recruiting
Barcelona, Spain, 08014
Contact: Resmini Eugenia, MD,PhD    0034651447732    resminieugenia@gmail.com   
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
A.O. Ospedale Papa Giovanni XXIII
Consorcio Centro de Investigación Biomédica en Red, M.P.
Investigators
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Principal Investigator: Eugenia Resmini, MD, PhD Ciberer and IIB Sant Pau
More Information
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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT04420000    
Other Study ID Numbers: IIBSP-MIN-2020-16
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We'll publish the data after completing the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Mindfulness
Acromgaly
Cushing
Quality Of Life
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases