The Effectiveness of a Systemic Mindfulness-based Intervention Program in a Cystic Fibrosis Clinic

NCT ID: NCT02131857

Last Updated: 2014-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-12-31

Brief Summary

Hypothesis 1: Mindfulness is a feasible tool for use within a cystic fibrosis (CF) clinic

Hypothesis 2: Participants in the mindfulness intervention will show an increased level of quality of life post intervention with the Mindfulness course

Hypothesis 3. Levels of mindfulness:

Participants in the mindfulness intervention will report increased mindfulness levels post-program completion as compared to pre-program completion

Hypothesis 4. Levels of stress:

Participants in the mindfulness intervention will report lower levels of stress post-program completion as compared with pre-program commencement.

Hypothesis 5. Levels of residual depressive symptoms post-mindfulness intervention program: Residual symptoms of depression are a risk factor for relapse of depression. Post -program participants of mindfulness will purport fewer residual depressive symptoms compared with pre-program.

Hypothesis 6. CF is associated with severe neutrophilic inflammation of the airways. As mindfulness intervention has been shown to modulate immune system it may improve physical aspects of CF including markers of inflammation and markers of lung disease (lung function tests and rate of pulmonary exacerbations) and nutritional state.

Detailed Description

The study will be an active interventional program for approximately six months in duration. All participants will initially undergo an initial assessment interview. Personnel trained and certified in mindfulness-based stress reduction (MBSR) will run mindfulness-based groups in 6-8 weekly 1 1/2 hour sessions (the staff group will comprise of 6 sessions and the parents' and patients' groups will be 8 sessions long). Participants will learn and engage in various formal and informal meditation practices during experiential learning of skills, including concentration, mindfulness of thoughts, emotions, feelings and bodily sensations, decentering, and letting go. Each group will include both practical exercises and a psycho-educational component. Daily homework, an essential aspect of the course, will include meditation practices together with exercises designed to integrate application of awareness skills into daily life. On day 0, participants will complete a battery of questionnaires as well as tests of the physical status of CF disease. This battery will be repeated at 8 weeks, and again at 6 months.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Staff

active interventional program based on Mindfulness training

Group Type: EXPERIMENTAL

active interventional program based on Mindfulness training

Intervention Type: BEHAVIORAL

active interventional program based on Mindfulness training

Parents

active interventional program based on Mindfulness training

Group Type: EXPERIMENTAL

active interventional program based on Mindfulness training

Intervention Type: BEHAVIORAL

active interventional program based on Mindfulness training

Patients with CF

active interventional program based on Mindfulness training

Group Type: EXPERIMENTAL

active interventional program based on Mindfulness training

Intervention Type: BEHAVIORAL

active interventional program based on Mindfulness training

Interventions

active interventional program based on Mindfulness training

active interventional program based on Mindfulness training

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of CF clinically and by sweat test and/ or genetic testing and/ or nasal potential difference

2. Treatment with one or more chronic medications or regimes;

3. Willingness by patient or parent to sign consent form;

4. Parents capable of complying with the program requirements including completing self-report questionnaires pre and post intervention completion.

Exclusion Criteria

1. Having significant developmental delay or a mental health diagnosis of psychosis;

2. Transplant patients;

3. Participation in other interventional studies within 2 weeks of recruitment or during the study period -

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

blau hannah

Director, Pulmonary Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hannah Blau, MBBS

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Hannah Blau, MBBS

Role: CONTACT

hblau@post.tau.ac.il

+972504057141

Michal Rivlin, PhD

Role: CONTACT

micheleri@clalit.org.il

+972522732463

Facility Contacts

Hannah Blau, MBBS

Role: primary

hblau@post.tau.ac.il

+972504057141

Other Identifiers

RMC-0321-12-ctil

Identifier Type: -

Identifier Source: org_study_id