Mindfulness Based Stress Reduction for Parents of Children With IBD

Overview

Parents of children with chronic diseases often report increased level of stress and anxiety. The aim of the study is to assess the effect of mindfulness based stress reduction (MBSR) intervention on stress and anxiety of parents of children with inflammatory bowel diseases (IBD). The intervention is consisted of 8 group sessions managed by a certified psychologist. 30 parents will participate. The efficacy of the intervention will be assessed by 3 validated questionnaires which will be filled by each participant prior to intervention, at the end of intervention and 3 months following interventions.

Full Title of Study: “The Effect of Mindfulness Based Stress Reduction on Parents of Children With Inflammatory Bowel Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 31, 2020

Detailed Description

Parents of children with chronic diseases often report increased level of stress and anxiety. Inflammatory bowel diseases (IBD), including crohn's disease and ulcerative colitis are chronic debilitating conditions with significant implications of both patients and parents. Thus, there is a necessity to address the stress and anxiety derived from parenting a child with IBD. Mindfulness is the psychological process of bringing one's attention to the internal and external experiences occurring in the present moment,which can be developed through the practice of meditation and other training. Clinical studies have documented both physical and mental health benefits of mindfulness in different patient categories as well as in healthy adults and children. The aim of the study is to assess the effect of mindfulness based stress reduction (MBSR) intervention on stress and anxiety of parents of children with inflammatory bowel diseases (IBD). The intervention is consisted of 8 group sessions managed by a certified psychologist. 30 parents will participate in 4 separated courses. The efficacy of the intervention will be assessed by 3 validated questionnaires which will be filled by each participant prior to intervention, at the end of intervention and 3 months following interventions: Profile of mood states (POMS), The brief symptom inventory (BSI) and perceived stress scale (PSS). Differences in questionnaires' scores will be analyzed.

Interventions

  • Behavioral: Mindfulness based stress reduction
    • Mindfulness based stress reduction consisted of 8 group sessions for parents of children with IBD

Arms, Groups and Cohorts

  • Experimental: Mindfulness based stress reduction
    • Parents of children with IBD will undergo mindfulness based stress reduction (MBSR) intervention consisted of 8 group sessions. The effect on stress and anxiety will be assessed using 3 validated questionnaires which will be filled prior to intervention, at the end of intervention and 3 months following intervention.

Clinical Trial Outcome Measures

Primary Measures

  • The change in perceived stress scale
    • Time Frame: At baseline and 3 months following intervention

Secondary Measures

  • The change in profile of mood states (POMS) score
    • Time Frame: At week 0 following intervention and 3 months following intervention compared with baseline
  • The change in brief symptom inventory (BSI) score
    • Time Frame: At week 0 following intervention and 3 months following intervention compared with baseline

Participating in This Clinical Trial

Inclusion Criteria

  • A parent to an IBD patient who is younger than 18 years of age Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Schneider Children’s Medical Center, Israel
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amit Assa, Head of IBD program – Schneider Children’s Medical Center, Israel
  • Overall Official(s)
    • Raanan Shamir, MD, Study Director, Schneider Children’s Medical Center, Israel

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