Cystic FibrosisMindfulnessNCT02131857
The Effectiveness of a Systemic Mindfulness-based Intervention Program in a Cystic Fibrosis Clinic
A study testing active interventional program based on Mindfulness training in people with Cystic Fibrosis, run by Rabin Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 8 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- active interventional program based on Mindfulness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- May 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Schneider Children's Medical Center of Israel
Petah Tikva, 49202
Hannah Blau, MBBS, +972504057141, hblau@post.tau.ac.il
Hannah Blau, MBBS
About this study
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
Read more
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.
Read the 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
- Being tested
- active interventional program based on Mindfulness training
- Keywords
- Mindfulness, stress reduction
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active interventional program based on Mindfulness trainingBehavioural
active interventional program based on Mindfulness training
| Study group | Role | What they receive |
|---|---|---|
| Staff | Experimental | active interventional program based on Mindfulness training Receives: Behavioral: active interventional program based on Mindfulness training |
| Parents | Experimental | active interventional program based on Mindfulness training Receives: Behavioral: active interventional program based on Mindfulness training |
| Patients with CF | Experimental | active interventional program based on Mindfulness training Receives: Behavioral: active interventional program based on Mindfulness training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (13)
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)
Measured: 6 months
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.
Measured: 6 months
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).
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
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).
Measured: 6 months
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)
Measured: 8 weeks
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.
Measured: 8 weeks
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).
Measured: 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)
spirometry technique for measuring lung function
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, blau hannah, Rabin Medical Center
- Investigators
- Hannah Blau, MBBS, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131857
- Sponsor's protocol ID
- RMC-0321-12-ctil
- Acronym
- Mindfulness
- Status last verified
- May 2014
- First submitted
- 28 Apr 2014
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Systemic Mindfulness-based Intervention Program in a Cystic Fibrosis Clinic
- ClinicalTrials.gov ID
- NCT02131857
- Acronym / sponsor ID
- Mindfulness / RMC-0321-12-ctil
- Conditions
- Cystic Fibrosis
- Keywords
- Mindfulness, stress reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 6 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Staff | Experimental | Behavioral: active interventional program based on Mindfulness trainingactive interventional program based on Mindfulness training |
| Parents | Experimental | Behavioral: active interventional program based on Mindfulness trainingactive interventional program based on Mindfulness training |
| Patients with CF | Experimental | Behavioral: active interventional program based on Mindfulness trainingactive interventional program based on Mindfulness training |
Who may qualify
- Ages
- 8 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active interventional program based on Mindfulness trainingactive interventional program based on Mindfulness training | Behavioural | Parents, Patients with CF, Staff |
Primary outcome
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).
13 secondary outcomes
scores on the Cystic Fibrosis Questionnaire (CFQ-R) on 12 domains
Time frame: 6 months
score on the Perceived Stress Scale (PSS)
Time frame: 6 months
Level of depression as assessed by the Beck Depression Inventory (BDI)
Time frame: 6 months
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)
Time frame: 6 months
CF related inflammation
Time frame: 6 months
Rate of pulmonary exacerbations
Time frame: 6 months
Score on the Mindful Attention Awareness Scale (MAAS)
Time frame: 6 months
scores on the Cystic Fibrosis Questionnaire (CFQ-R) on 12 domains
Time frame: 8 weeks
score on the Perceived Stress Scale (PSS)
Time frame: 8 weeks
Level of depression as assessed by the Beck Depression Inventory (BDI)
Time frame: 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)
Time frame: 8 weeks
CF related inflammation
Time frame: 8 weeks
Rate of pulmonary exacerbations
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Blau, MBBS principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active interventional program based on Mindfulness training in people with Cystic Fibrosis, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannah Blau, MBBS (+972504057141, hblau@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the Mindful Attention Awareness Scale (MAAS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.