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Completed

NCT Number: NCT02991443

Mindfulness Based Stress Reduction for Parents of Children With IBD

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schneider Children's Hospital

Petah Tikva, 4920235, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Mindfulness Based Stress Reduction

Behavioral

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

Primary outcomes

  1. The change in perceived stress scale

    Time frame: At baseline and 3 months following intervention

Secondary outcomes

  1. The change in profile of mood states (POMS) score

    Time frame: At week 0 following intervention and 3 months following intervention compared with baseline

  2. The change in brief symptom inventory (BSI) score

    Time frame: At week 0 following intervention and 3 months following intervention compared with baseline

Sponsors and collaborators

Lead sponsor

Schneider Children's Medical Center, Israel

Other

Registry information

Official study title

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

Acronym: Mindful

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 13, 2016
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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