Mindfulness Based Stress Reduction for Parents of Children With IBD

Inflammatory Bowel Diseases Clinical Trial

— Mindful  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991443
• Other study ID #: MindfulnessSMCIBD
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: October 15, 2020

Study information

• Verified date: September 2021
• Source: Schneider Children's Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 15, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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

Locations

Country	Name	City	State
Israel	Schneider Children's Hospital	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Schneider Children's Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in perceived stress scale		At baseline and 3 months following intervention
Secondary	The change in profile of mood states (POMS) score		At week 0 following intervention and 3 months following intervention compared with baseline
Secondary	The change in brief symptom inventory (BSI) score		At week 0 following intervention and 3 months following intervention compared with baseline