Effects of Mindfulness Therapy in Patients With Acromegaly and Cushing

NCT04420000 | Completed

• 1 other identifier: IIBSP-MIN-2020-16
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Satisfaction

Keywords

Mindfulness; Acromgaly; Cushing; Quality Of Life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in Pain in patients with acromegaly and Cushing's syndrome

  Baseline, post-intervention (8 weeks)

• Change in Mood in patients with acromegaly and Cushing's syndrome

  Baseline, post-intervention (8 weeks)

• Change in Sleep in patients with acromegaly and Cushing's syndrome

  Baseline, post-intervention (8 weeks)

Study Arms (2)

Interventional group

EXPERIMENTAL

Patients having a Mindfulness program

Behavioral: Mindfulness

Control group

PLACEBO COMPARATOR

Patients having a routinary managment

Other: Control

Interventions

Mindfulness BEHAVIORAL

Mindfulness based programme

Interventional group

Control OTHER

Treatment as usual

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Psychiatric disorders
• Previous experience with Mindfulness
• Participation in other clinical trials

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• A.O. Ospedale Papa Giovanni XXIII: collaborator
• Consorcio Centro de Investigación Biomédica en Red (CIBER): collaborator

Study Sites (1)

Resmini Eugenia

Barcelona, 08014, Spain

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Eugenia Resmini, MD, PhD

  Ciberer and IIB Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 9, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)