The Effectiveness of a Systemic Mindfulness-based Intervention Program in a Cystic Fibrosis Clinic
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rabin Medical Center
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Score on the Mindful Attention Awareness Scale (MAAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diagnosis of CF clinically and by sweat test and/ or genetic testing and/ or nasal potential difference
- •Treatment with one or more chronic medications or regimes;
- •Willingness by patient or parent to sign consent form;
- •Parents capable of complying with the program requirements including completing self-report questionnaires pre and post intervention completion.
Exclusion Criteria
- •Having significant developmental delay or a mental health diagnosis of psychosis;
- •Transplant patients;
- •Participation in other interventional studies within 2 weeks of recruitment or during the study period -
Outcomes
Primary Outcomes
Score on the Mindful Attention Awareness Scale (MAAS)
Time Frame: 8 weeks
The MAAS assesses individual differences in the frequency of mindful states over time and focuses on the presence or absence of attention to and awareness of what is occurring in the present. The MAAS includes a 15-item scale where respondents indicate how frequently they have the experience described in each statement using a 6-point Likert scale. Changes in MAAS-measured mindfulness pre-to post-intervention have been related to declines in mood disturbance and stress (reference #18).
Secondary Outcomes
- scores on the Cystic Fibrosis Questionnaire (CFQ-R) on 12 domains(8 weeks)
- score on the Perceived Stress Scale (PSS)(8 weeks)
- Level of depression as assessed by the Beck Depression Inventory (BDI)(8 weeks)
- 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)(8 weeks)
- CF related inflammation(8 weeks)
- Rate of pulmonary exacerbations(8 weeks)
- Score on the Mindful Attention Awareness Scale (MAAS)(6 months)
Investigators
blau hannah
Director, Pulmonary Institute
Rabin Medical Center