NCT02222064

Brief Summary

Research questions/hypotheses

  1. 1.Can an individual mindfulness intervention for Gastro Intestinal Failure inpatients reduce pain-related distress, improve quality of life, and increase confidence in pain self-management?
  2. 2.How useful and applicable do Gastro Intestinal Failure inpatients find Mindfulness methods?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 4, 2015

Status Verified

May 1, 2015

Enrollment Period

10 months

First QC Date

August 12, 2014

Last Update Submit

December 3, 2015

Conditions

Gastro-intestinal Pain

Outcome Measures

Primary Outcomes (1)

  • Change in pain distress rating on 11 point numerical rating scale

    A numerical rating scale scored from 0 to 10 which asks "how distressing is the pain on average in the last week with 0 being not distressing at all and 10 being extreme distress"

    Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8

Secondary Outcomes (7)

  • Hospital Anxiety and Depression Scale

    At baseline, week 8

  • Pain Self Efficacy Questionnaire

    At baseline, week 8

  • Chronic Pain Acceptance Questionnaire

    At baseline, week 8

  • Five Facet Mindfulness Questionnaire

    At baseline, week 8

  • Self-report record of using mindfulness exercises (frequency and duration)

    Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8

  • +2 more secondary outcomes

Study Arms (1)

Mindfulness

EXPERIMENTAL

8 week self-managed mindfulness based intervention

Behavioral: Mindfulness

Interventions

MindfulnessBEHAVIORAL

Mindfulness is a psychological intervention based on increasing skills of non-judgemental awareness using meditations. In this study a self-directed 8 week course of mindfulness will be used involving self-help materials in the form of a book and 8 guided meditations on audio files.

Mindfulness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years, pain experienced
  • \>3 months, proficiency in English

You may not qualify if:

  • previous mindfulness experience
  • severe cognitive impairment
  • profound hearing difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Hospital

London, NW1 2BU, United Kingdom

Location

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 21, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

December 4, 2015

Record last verified: 2015-05

Locations

GB(1)