Mindfulness Based Stress Reduction for Parents of Children With IBD (Mindful)

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Behavioral: Mindfulness based stress reduction

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petach Tikva, Israel, 4920235
    • Schneider Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change in perceived stress scale	At baseline and 3 months following intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
The change in profile of mood states (POMS) score	At week 0 following intervention and 3 months following intervention compared with baseline
The change in brief symptom inventory (BSI) score	At week 0 following intervention and 3 months following intervention compared with baseline

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): October 15, 2020

Study Registration Dates

• First Submitted: December 8, 2016
• First Submitted That Met QC Criteria: December 9, 2016
• First Posted (Estimate): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 25, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: MindfulnessSMCIBD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO