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Effects of Mindfulness Therapy in Patients With Acromegaly and Cushing

Primary Purpose

Patient Satisfaction

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mindfulness
Control
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Patient Satisfaction focused on measuring Mindfulness, Acromgaly, Cushing, Quality Of Life

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Resmini Eugenia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Interventional group

Control group

Arm Description

Patients having a Mindfulness program

Patients having a routinary managment

Outcomes

Primary Outcome Measures

Change in quality of life in patients with acromegaly
using the Acromegaly Quality of Life Questionnaire (AcroQoL)
Change in quality of life in patients with Cushing's syndrome
using the Cushing's Quality-of-Life (CushingQOL) questionnaire

Secondary Outcome Measures

Full Information

First Posted
May 27, 2020
Last Updated
March 15, 2023
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)
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1. Study Identification

Unique Protocol Identification Number
NCT04420000
Brief Title
Effects of Mindfulness Therapy in Patients With Acromegaly and Cushing
Official Title
Effects of Mindfulness Therapy in Patients With Acromegaly and in Patients With Cushing's Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Satisfaction
Keywords
Mindfulness, Acromgaly, Cushing, Quality Of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Patients having a Mindfulness program
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients having a routinary managment
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
Mindfulness based programme
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Treatment as usual
Primary Outcome Measure Information:
Title
Change in quality of life in patients with acromegaly
Description
using the Acromegaly Quality of Life Questionnaire (AcroQoL)
Time Frame
Baseline, post-intervention (8 weeks)
Title
Change in quality of life in patients with Cushing's syndrome
Description
using the Cushing's Quality-of-Life (CushingQOL) questionnaire
Time Frame
Baseline, post-intervention (8 weeks)
Other Pre-specified Outcome Measures:
Title
Change in Pain in patients with acromegaly and Cushing's syndrome
Description
as evaluated using the McGill Pain Questionnaire
Time Frame
Baseline, post-intervention (8 weeks)
Title
Change in Mood in patients with acromegaly and Cushing's syndrome
Description
as evaluate using Hospital Anxiety and Depression Scale (HADS)
Time Frame
Baseline, post-intervention (8 weeks)
Title
Change in Sleep in patients with acromegaly and Cushing's syndrome
Description
as evaluate using Pittsburgh sleep scale
Time Frame
Baseline, post-intervention (8 weeks)
Title
Self compassion in patients with acromegaly and Cushing's syndrome
Description
as evaluate using Self Compassion Scale (SCS)
Time Frame
Baseline, post-intervention (8 weeks)
Title
Satisfation with life in patients with acromegaly and Cushing's syndrome
Description
as evaluate using SWLS questionnaire
Time Frame
Baseline, post-intervention (8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugenia Resmini, MD, PhD
Organizational Affiliation
Ciberer and IIB Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Resmini Eugenia
City
Barcelona
ZIP/Postal Code
08014
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We'll publish the data after completing the study

Learn more about this trial

Effects of Mindfulness Therapy in Patients With Acromegaly and Cushing

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