Effects of Mindfulness Therapy in Patients With Acromegaly and Cushing

Effects of Mindfulness Therapy in Patients With Acromegaly and in Patients With Cushing's Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction
• Intervention / Treatment: Other: Control; Behavioral: Mindfulness

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eugenia Resmini, MD, PhD; Phone Number: 34935537917; Email: eresmini@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain, 08014
    • Resmini Eugenia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life in patients with acromegaly	using the Acromegaly Quality of Life Questionnaire (AcroQoL)	Baseline, post-intervention (8 weeks)
Change in quality of life in patients with Cushing's syndrome	using the Cushing's Quality-of-Life (CushingQOL) questionnaire	Baseline, post-intervention (8 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain in patients with acromegaly and Cushing's syndrome	as evaluated using the McGill Pain Questionnaire	Baseline, post-intervention (8 weeks)
Change in Mood in patients with acromegaly and Cushing's syndrome	as evaluate using Hospital Anxiety and Depression Scale (HADS)	Baseline, post-intervention (8 weeks)
Change in Sleep in patients with acromegaly and Cushing's syndrome	as evaluate using Pittsburgh sleep scale	Baseline, post-intervention (8 weeks)
Self compassion in patients with acromegaly and Cushing's syndrome	as evaluate using Self Compassion Scale (SCS)	Baseline, post-intervention (8 weeks)
Satisfation with life in patients with acromegaly and Cushing's syndrome	as evaluate using SWLS questionnaire	Baseline, post-intervention (8 weeks)

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: A.O. Ospedale Papa Giovanni XXIII; Consorcio Centro de Investigación Biomédica en Red (CIBER)
• Investigators: Principal Investigator: Eugenia Resmini, MD, PhD, Ciberer and IIB Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Mindfulness; Cushing; Quality Of Life; Acromgaly
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Pituitary Diseases; Acromegaly
• Other Study ID Numbers: IIBSP-MIN-2020-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We'll publish the data after completing the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No