Mindfulness Based Stress Reduction for Parents of Children With IBD (Mindful)
Primary Purpose
Inflammatory Bowel Diseases
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Mindfulness based stress reduction
Sponsored by
About this trial
This is an interventional supportive care trial for Inflammatory Bowel Diseases
Eligibility Criteria
Inclusion Criteria:
- A parent to an IBD patient who is younger than 18 years of age
Exclusion Criteria:
- None
Sites / Locations
- Schneider Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mindfulness based stress reduction
Arm Description
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.
Outcomes
Primary Outcome Measures
The change in perceived stress scale
Secondary Outcome Measures
The change in profile of mood states (POMS) score
The change in brief symptom inventory (BSI) score
Full Information
NCT ID
NCT02991443
First Posted
December 8, 2016
Last Updated
September 25, 2021
Sponsor
Schneider Children's Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT02991443
Brief Title
Mindfulness Based Stress Reduction for Parents of Children With IBD
Acronym
Mindful
Official Title
The Effect of Mindfulness Based Stress Reduction on Parents of Children With Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schneider Children's Medical Center, Israel
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness based stress reduction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based stress reduction
Intervention Description
Mindfulness based stress reduction consisted of 8 group sessions for parents of children with IBD
Primary Outcome Measure Information:
Title
The change in perceived stress scale
Time Frame
At baseline and 3 months following intervention
Secondary Outcome Measure Information:
Title
The change in profile of mood states (POMS) score
Time Frame
At week 0 following intervention and 3 months following intervention compared with baseline
Title
The change in brief symptom inventory (BSI) score
Time Frame
At week 0 following intervention and 3 months following intervention compared with baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A parent to an IBD patient who is younger than 18 years of age
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raanan Shamir, MD
Organizational Affiliation
Schneider Children's Medical Center, Israel
Official's Role
Study Director
Facility Information:
Facility Name
Schneider Children's Hospital
City
Petach Tikva
ZIP/Postal Code
4920235
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mindfulness Based Stress Reduction for Parents of Children With IBD
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