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

Clalit Health Services

Status: Unknown

Conditions: Cystic Fibrosis

Treatments: Behavioral: active interventional program based on Mindfulness training

Study type: Interventional

Funder types: Other

Identifiers

NCT02131857

RMC-0321-12-ctil

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 8 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Staff

Experimental group

Description:

active interventional program based on Mindfulness training

Treatment:

Behavioral: active interventional program based on Mindfulness training

Parents

Experimental group

Description:

active interventional program based on Mindfulness training

Treatment:

Behavioral: active interventional program based on Mindfulness training

Patients with CF

Experimental group

Description:

active interventional program based on Mindfulness training

Treatment:

Behavioral: active interventional program based on Mindfulness training