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

Cystic Fibrosis Clinical Trial

— Mindfulness  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02131857
• Other study ID #: RMC-0321-12-ctil
• Status: Recruiting
• Phase: N/A
• First received: April 28, 2014
• Last updated: May 4, 2014
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2014
• Source: Rabin Medical Center
• Contact: Hannah Blau, MBBS
• Phone: +972504057141
• Email: hblau[@]post.tau.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 65 Years

Eligibility

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 -

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• active interventional program based on Mindfulness training
active interventional program based on Mindfulness training

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the Mindful Attention Awareness Scale (MAAS)	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).	8 weeks	No
Secondary	scores on the Cystic Fibrosis Questionnaire (CFQ-R) on 12 domains	The CFQ Is a disease-specific instrument designed to measure impact on overall health, daily life, perceived well-being and symptoms, developed specifically for use in patients with a diagnosis of cystic fibrosis. The measure consists of 12 subscales: Physical, Role, Vitality, Emotional State, Social/Marginalization, Body Image, Eating Disturbance, Treatment Burden, Perception of Health, Weight, Respiratory, and Digestion. Scores range from 0-100, with higher scores indicating better health-related quality of life (HRQOL). All subscales have been shown to have adequate internal consistency and test-retest reliability and have demonstrated good convergent and discriminant validity. (reference #17)	6 months	No
Secondary	score on the Perceived Stress Scale (PSS)	Perceived Stress Scale (reference #19): The PSS measures the degree to which individuals perceive their daily life as being stressful during the last month with a 5-point Likert scale (0 = never and 4 = very often). Total scores can range from 0 to 40. Higher scores on the PSS represent higher levels of perceived stress.	6 months	No
Secondary	Level of depression as assessed by the Beck Depression Inventory (BDI)	The BDI is a 21-item self - report measure of depressive symptoms. Each item presents one symptom at four levels of intensity scored from 0 to 3 yielding total scores ranging from 0 to 60, with 60 being the most extreme score of depression. The BDI has been found to be a reliable and valid measure of the severity of depressive symptoms in college students and adults (21) and in adolescents (22).	6 months	No
Secondary	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)	The FEV1, FEF25-75 and FVC are assessed by spirometry techniques as done in the routine procedures in the Pulmonary clinic	6 months	No
Secondary	CF related inflammation	levels of serum C-reactive protein (CRP), sputum neutrophil %,serum interleukin 8 (IL-8) and neutrophil elastase will be assessed by routine laboratory methods in the hospital laboratory	6 months	No
Secondary	Rate of pulmonary exacerbations	the rate of pulmonary exacerbations will be assessed by the number of days on IV antibiotics as well as pulmonary exacerbations as defined by the FUCHS criteria	6 months	No
Secondary	Score on the Mindful Attention Awareness Scale (MAAS)	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).	6 months	No
Secondary	scores on the Cystic Fibrosis Questionnaire (CFQ-R) on 12 domains	The CFQ Is a disease-specific instrument designed to measure impact on overall health, daily life, perceived well-being and symptoms, developed specifically for use in patients with a diagnosis of cystic fibrosis. The measure consists of 12 subscales: Physical, Role, Vitality, Emotional State, Social/Marginalization, Body Image, Eating Disturbance, Treatment Burden, Perception of Health, Weight, Respiratory, and Digestion. Scores range from 0-100, with higher scores indicating better health-related quality of life (HRQOL). All subscales have been shown to have adequate internal consistency and test-retest reliability and have demonstrated good convergent and discriminant validity. (reference #17)	8 weeks	No
Secondary	score on the Perceived Stress Scale (PSS)	Perceived Stress Scale (reference #19): The PSS measures the degree to which individuals perceive their daily life as being stressful during the last month with a 5-point Likert scale (0 = never and 4 = very often). Total scores can range from 0 to 40. Higher scores on the PSS represent higher levels of perceived stress.	8 weeks	No
Secondary	Level of depression as assessed by the Beck Depression Inventory (BDI)	The BDI is a 21-item self - report measure of depressive symptoms. Each item presents one symptom at four levels of intensity scored from 0 to 3 yielding total scores ranging from 0 to 60, with 60 being the most extreme score of depression. The BDI has been found to be a reliable and valid measure of the severity of depressive symptoms in college students and adults (21) and in adolescents (22).	8 weeks	No
Secondary	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)	spirometry technique for measuring lung function	8 weeks	No
Secondary	CF related inflammation	levels of serum C-reactive protein (CRP), sputum neutrophil %,serum interleukin 8 (IL-8) and neutrophil elastase will be assessed by routine laboratory methods in the hospital laboratory	8 weeks	No
Secondary	Rate of pulmonary exacerbations	the rate of pulmonary exacerbations will be assessed by the number of days on IV antibiotics as well as pulmonary exacerbations as defined by the FUCHS criteria	8 weeks	No