Mindfulness Based Stress Reduction for Parents of Children With IBD

NCT ID: NCT02991443

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2020-10-15

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.

Conditions

Inflammatory Bowel Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness based stress reduction

Intervention Type: BEHAVIORAL

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

Interventions

Mindfulness based stress reduction

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schneider Children's Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Amit Assa

Head of IBD program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raanan Shamir, MD

Role: STUDY_DIRECTOR

Schneider Children's Medical Center, Israel

Locations

Schneider Children's Hospital

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

MindfulnessSMCIBD

Identifier Type: -

Identifier Source: org_study_id