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Completed

NCT Number: NCT04420000

Effects of Mindfulness Therapy in Patients With Acromegaly and Cushing

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.

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Key information

Conditions

Patient Satisfaction Behavior Health Behavior Treatment Adherence and Compliance

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Resmini Eugenia

Barcelona, 08014, Spain

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness

Behavioral

Mindfulness based programme

Control

Other

Treatment as usual

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Collaborators

  • A.O. Ospedale Papa Giovanni XXIII
  • Consorcio Centro de Investigación Biomédica en Red (CIBER)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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