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CompletedNCT02991443MindfulUpdated Sep 28, 2021

Mindfulness Based Stress Reduction for Parents of Children With IBD

An interventional study of Mindfulness based stress reduction in Inflammatory Bowel Diseases, sponsored by Schneider Children's Medical Center, Israel. Completed at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-09-28.

Sponsored by Schneider Children's Medical Center, Israel · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Inflammatory Bowel Diseases
03

In context

Intestinal Diseases

963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.

This study's enrollment of 30 is below the median of 70 across 552 interventional studies indexed under Intestinal Diseases.

Browse Intestinal Diseases studies →

Lead sponsor

Schneider Children's Medical Center, Israel is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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.

    Behavioral: Mindfulness based stress reduction

Interventions

  • BehavioralMindfulness based stress reduction

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

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What researchers measure

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

07

Study locations

1 site
  • Schneider Children's Hospital
    Petach Tikva, 4920235, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02991443
Lead sponsor
Schneider Children's Medical Center, Israel
Responsible party
Amit Assa (Head of IBD program, Schneider Children's Medical Center, Israel) — Principal investigator
First posted
Dec 13, 2016
Start date
Dec 2016
Primary completion
Jul 31, 2020
Completion
Oct 15, 2020
Last update
Sep 28, 2021

Study contacts

Raanan Shamir, MD
study director · Schneider Children's Medical Center, Israel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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