Clinical trial NCT02991443: Mindfulness Based Stress Reduction for Parents of Children With IBD
Official title: The Effect of Mindfulness Based Stress Reduction on Parents of Children With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Schneider Children's Medical Center, Israel
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* A parent to an IBD patient who is younger than 18 years of age

Exclusion Criteria:

* None

Primary outcomes:
measure: The change in perceived stress scale
timeFrame: At baseline and 3 months following intervention
Secondary outcomes:
measure: The change in profile of mood states (POMS) score
timeFrame: At week 0 following intervention and 3 months following intervention compared with baseline
measure: The change in brief symptom inventory (BSI) score
timeFrame: At week 0 following intervention and 3 months following intervention compared with baseline
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Children's Hospital
Study officials:
affiliation: Schneider Children's Medical Center, Israel
name: Raanan Shamir, MD
role: STUDY_DIRECTOR
References: