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

NCT02131857 | Unknown

• 1 other identifier: RMC-0321-12-ctil
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Mindfulness; stress reduction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• scores on the Cystic Fibrosis Questionnaire (CFQ-R) on 12 domains

  6 months

• score on the Perceived Stress Scale (PSS)

  6 months

• Level of depression as assessed by the Beck Depression Inventory (BDI)

  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)

  6 months

• CF related inflammation

  6 months

Study Arms (3)

Staff

EXPERIMENTAL

active interventional program based on Mindfulness training

Behavioral: active interventional program based on Mindfulness training

Parents

EXPERIMENTAL

active interventional program based on Mindfulness training

Behavioral: active interventional program based on Mindfulness training

Patients with CF

EXPERIMENTAL

active interventional program based on Mindfulness training

Behavioral: active interventional program based on Mindfulness training

Interventions

active interventional program based on Mindfulness training BEHAVIORAL

active interventional program based on Mindfulness training

Parents; Patients with CF; Staff

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Hannah Blau, MBBS

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Blau, MBBS

CONTACT

+972504057141; hblau@post.tau.ac.il

Michal Rivlin, PhD

CONTACT

+972522732463; micheleri@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pulmonary Institute

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 6, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

IL (1)