Mindfulness Based Stress Reduction for Parents of Children With IBD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Mindfulness Based Stress Reduction on Parents of Children With Inflammatory Bowel Disease

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Behavioral: Mindfulness based stress reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A parent to an IBD patient who is younger than 18 years of age Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness based stress reduction<br>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. | Behavioral: Mindfulness based stress reduction<br>* Mindfulness based stress reduction consisted of 8 group sessions for parents of children with IBD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in perceived stress scale |  | At baseline and 3 months following intervention | 

Secondary Outcome Measures

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