Mindfulness Based Stress Reduction for Parents of Children With IBD

Sponsor
Schneider Children's Medical Center, Israel (Other)
Overall Status
Completed
CT.gov ID
NCT02991443
Collaborator
(none)
30
1
1
46.5
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness based stress reduction
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Mindfulness Based Stress Reduction on Parents of Children With Inflammatory Bowel Disease
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Jul 31, 2020
Actual Study Completion Date :
Oct 15, 2020

Arms and Interventions

Arm Intervention/Treatment
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
Mindfulness based stress reduction consisted of 8 group sessions for parents of children with IBD

Outcome Measures

Primary Outcome Measures

  1. The change in perceived stress scale [At baseline and 3 months following intervention]

Secondary Outcome Measures

  1. The change in profile of mood states (POMS) score [At week 0 following intervention and 3 months following intervention compared with baseline]

  2. The change in brief symptom inventory (BSI) score [At week 0 following intervention and 3 months following intervention compared with baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • A parent to an IBD patient who is younger than 18 years of age
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Schneider Children's Hospital Petach Tikva Israel 4920235

Sponsors and Collaborators

  • Schneider Children's Medical Center, Israel

Investigators

  • Study Director: Raanan Shamir, MD, Schneider Children's Medical Center, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amit Assa, Head of IBD program, Schneider Children's Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT02991443
Other Study ID Numbers:
  • MindfulnessSMCIBD
First Posted:
Dec 13, 2016
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2021