A Pilot and Feasibility Trial of a Group Mindfulness and Self-compassion Intervention for Young People Diagnosed With IBD

NCT04100239 | Unknown

• 1 other identifier: 159047
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Young people with IBD face all the usual complexities of growing up, with the additional complications of having a chronic health condition, often recently diagnosed, which can have a detrimental impact on their mental health. This research seeks to examine the potential effectiveness of a two-stage intervention for young people with IBD via a pilot feasibility trial. First, a mindfulness-based stress reduction (MBSR) group with a "Mindfulness based compassionate living" (MBCL) group delivered soon afterwards. Both interventions will be delivered online. MBSR aims to increase peoples awareness of their tendency to get caught up in thoughts and help them live in the present moment. Once an individual has achieved greater awareness of their thought processes, MBCL then aims to help individuals to become kinder to themselves, and less critical. We know from interview studies with young people with IBD that they can be harsh on themselves about how they are coping, and being harsh and critical can impact wellbeing. By targeting mindfulness and self-compassion we hope to demonstrate a positive impact on wellbeing, by reducing stress, anxiety and depression and improving quality of life (primary outcome measures) for young people with IBD and equip them with a mindfulness practice to use in the future as they continue to manage their IBD.

Conditions

Inflammatory Bowel Diseases

Keywords

inflammatory bowel disease; mindfulness; self-compassion; young people; pilot study

Outcome Measures

Primary Outcomes (3)

• Change from Baseline Psychological Distress at 6 time points

  Psychological distress will be measured using 21-item The Depression Anxiety Stress Scales-Short Form (DASS-21). Participants will rate themselves on items such as, "I found myself feeling agitated, according to a 4-point Likert scale, higher scores indicating greater psychological distress. The measure yields three subscale scores: depression (range from 0 to 42), anxiety (range from 0 to 42), stress (range from 0 to 42), and an overall psychological distress total score (range from 0 to 126). The total score is computed by summing the subscale scores.

  When the intervention commences, 8-weeks, 12 weeks, 20 weeks, 33 weeks and 59 weeks; and at equivalent times for controls.

• Change from Baseline Quality of Life at 6 time points

  Quality of life will be measured using the Inflammatory Bowel Disease Questionnaire (IBDQ). Participants rate themselves on items such as, "how frequent have your bowel movements been during the last two weeks?" according to seven point scales, lower scores indicating poorer health status in all subscales. The IBDQ is a 32-item self-report measure assessing quality of life, yielding four subscale scores: bowel symptoms (ranging from 10 to 70), systemic symptoms (range 5 to 35), emotional function (range 12 to 84) and social function (range 5 to 35) and a global subjective health status score calculated by summing the subscale scores (range from 32 to 224).

  When the intervention commences, 8-weeks, 12 weeks, 20 weeks, 33 weeks and 59 weeks; and at equivalent times for controls

• Change from Baseline Disease Activity at 3 time points

  Disease activity will be measured by faecal calprotectin levels, a biological measure of disease activity. Calprotectin is activated when inflammation occurs (whatever the cause of that may be) and thus can be used as a diagnostic indicator. The concentration of calprotectin relates directly to the severity of the inflammation.

  8-weeks, 20 weeks, and 59 weeks.

Secondary Outcomes (7)

• Change from Baseline Mindfulness at 6 time points

  When the intervention commences, 8-weeks, 12 weeks, 20 weeks, 33 weeks and 59 weeks; and at equivalent times for controls

• Change from Baseline Self-Compassion at 6 time points

  When the intervention commences, 8-weeks, 12 weeks, 20 weeks, 33 weeks and 59 weeks; and at equivalent times for controls

• Change from Baseline Sleep Disturbance at 6 time points

  When the intervention commences, 8-weeks, 12 weeks, 20 weeks, 33 weeks and 59 weeks; and at equivalent times for controls

• Change from Baseline Fatigue at 6 time points

  When the intervention commences, 8-weeks, 12 weeks, 20 weeks, 33 weeks and 59 weeks; and at equivalent times for controls

• Change from Baseline Pain Interference and Intensity at 6 time points

  When the intervention commences, 8-weeks, 12 weeks, 20 weeks, 33 weeks and 59 weeks; and at equivalent times for controls

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Open continuous recruitment of participants to trial where all participants begin the study as 'control participants' and at regular 'steps' participants are allocated to next available intervention group and cross from the control to the intervention condition, until all groups have completed the intervention.

Behavioral: Mindfulness-based stress reduction (MBSR)

Interventions

Mindfulness-based stress reduction (MBSR) BEHAVIORAL

MBSR is designed to complement any existing medical treatments, and focuses on the development of mindfulness meditation practice to alleviate psychological distress. MBCL is designed as a follow-up intervention to MBSR and aims to help individuals to turn towards suffering and developing a kind attitude to the self.

Also known as: Mindfulness-based compassionate living (MBCL)

Intervention Arm

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 16-25
• Confirmed diagnosis of IBD
• Be able to verbally communicate and write in English
• Be able to give informed consent
• Be able to engage in light exercise (required for the intervention)
• Be able to commit to home practice

You may not qualify if:

• Major psychiatric illness
• Active alcohol/drug dependency
• Scheduled for major surgery in the next 3 months
• Participation in any other IBD intervention studies within the last 6 months
• Prescribed antidepressants within the last 3 months.

Sponsors & Collaborators

• University of Sheffield: lead
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Department of Clinical Psychology, University of Sheffield

Sheffield, South Yorkshire, S1 2LT, United Kingdom

RECRUITING

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

• Georgina Rowse, Clin.Psy.D

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Yeates, Clin.Psy.D

CONTACT

0114 22; r.yeates@sheffield.ac.uk

Georgina Rowse, Clin.Psy.D

CONTACT

0114 22; g.rowse@sheffield.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed as a pilot and feasibility trial, using a stepwedged design. Pilot trials are used in advance of a larger future definitive randomised controlled trial (RCT) to focus on the development and refinement of the intervention, assess potential effectiveness, intervention acceptability and to determine whether a larger RCT is feasible. In step-wedged designs, all participants begin the study as 'control participants' and at regular 'steps' one group is crosses from the control to the intervention condition, until all groups have completed the intervention.

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 24, 2019
• Study Start: November 1, 2019
• Primary Completion: April 30, 2023
• Study Completion: September 30, 2023
• Last Updated: April 30, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Data will become available when all analysis is complete and the findings are being prepared for publication
• Access Criteria: Only the anonymised quantitative dataset will be made available

Locations

GB (1)