Clinical trial NCT02131857: The Effectiveness of a Systemic Mindfulness-based Intervention Program in a Cystic Fibrosis Clinic
Official title: The Effectiveness of a Systemic Mindfulness-based Intervention Program in a Cystic Fibrosis Clinic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Mindfulness
stress reduction
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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 -

Primary outcomes:
measure: Score on the Mindful Attention Awareness Scale (MAAS)
timeFrame: 8 weeks
Secondary outcomes:
measure: scores on the Cystic Fibrosis Questionnaire (CFQ-R) on 12 domains
timeFrame: 6 months
measure: score on the Perceived Stress Scale (PSS)
timeFrame: 6 months
measure: Level of depression as assessed by the Beck Depression Inventory (BDI)
timeFrame: 6 months
measure: Pulmonary function as assessed by spirometry: forced expiratory volume in one second (FEV1), forced expiratory flow 25-75% (FEF25-75), and forced vital capacity (FVC)
timeFrame: 6 months
measure: CF related inflammation
timeFrame: 6 months
measure: Rate of pulmonary exacerbations
timeFrame: 6 months
measure: Score on the Mindful Attention Awareness Scale (MAAS)
timeFrame: 6 months
measure: scores on the Cystic Fibrosis Questionnaire (CFQ-R) on 12 domains
timeFrame: 8 weeks
measure: score on the Perceived Stress Scale (PSS)
timeFrame: 8 weeks
measure: Level of depression as assessed by the Beck Depression Inventory (BDI)
timeFrame: 8 weeks
measure: Pulmonary function as assessed by spirometry: forced expiratory volume in one second (FEV1), forced expiratory flow 25-75% (FEF25-75), and forced vital capacity (FVC)
timeFrame: 8 weeks
measure: CF related inflammation
timeFrame: 8 weeks
measure: Rate of pulmonary exacerbations
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Rabin Medical Center
name: Hannah Blau, MBBS
role: PRINCIPAL_INVESTIGATOR
References: