Mindfulness Based Stress Reduction for Parents of Children With IBD

NCT02991443 | Completed

• 1 other identifier: MindfulnessSMCIBD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• The change in perceived stress scale

  At baseline and 3 months following intervention

Secondary Outcomes (2)

• 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

Study Arms (1)

Mindfulness based stress reduction

EXPERIMENTAL

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

Interventions

Mindfulness based stress reduction BEHAVIORAL

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

Mindfulness based stress reduction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Schneider Children's Medical Center, Israel: lead

Study Sites (1)

Schneider Children's Hospital

Petah Tikva, 4920235, Israel

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Raanan Shamir, MD

  Schneider Children's Medical Center, Israel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of IBD program

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 13, 2016
• Study Start: December 1, 2016
• Primary Completion: July 31, 2020
• Study Completion: October 15, 2020
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)