Effects of Mindfulness Therapy in Patients With Acromegaly and Cushing
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|ClinicalTrials.gov Identifier: NCT04420000|
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : September 30, 2020
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|
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.
- 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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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|
Experimental: Interventional group
Patients having a Mindfulness program
Mindfulness based programme
Placebo Comparator: Control group
Patients having a routinary managment
Treatment as usual
- Change in quality of life in patients with acromegaly [ Time Frame: Baseline, post-intervention (8 weeks) ]using the Acromegaly Quality of Life Questionnaire (AcroQoL)
- 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
- 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
- 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)
- Change in Sleep in patients with acromegaly and Cushing's syndrome [ Time Frame: Baseline, post-intervention (8 weeks) ]as evaluate using Pittsburgh sleep scale
- Self compassion in patients with acromegaly and Cushing's syndrome [ Time Frame: Baseline, post-intervention (8 weeks) ]as evaluate using Self Compassion Scale (SCS)
- Satisfation with life in patients with acromegaly and Cushing's syndrome [ Time Frame: Baseline, post-intervention (8 weeks) ]as evaluate using SWLS questionnaire
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
|Contact: Eugenia Resmini, MD, PhDfirstname.lastname@example.org|
|Barcelona, Spain, 08014|
|Contact: Resmini Eugenia, MD,PhD 0034651447732 email@example.com|
|Principal Investigator:||Eugenia Resmini, MD, PhD||Ciberer and IIB Sant Pau|