Hypnotherapy for Prevention of Relapse in Ulcerative Colitis: a Randomised, Single-blind, Controlled Clinical Trial

NCT00553163 | Terminated Results DMC

• 1 other identifier: BMRP proposal no IBD 0213
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

There is increasing evidence that worsening of ulcerative colitis (UC) can be provoked by psychological stresses. When this protocol was devised, there had been no proper scientific studies to find out whether stress reduction can improve the course of UC. Hypnotherapy is a technique by which a practitioner induces a temporary trance-like state in patients: while they are in this state, the practitioner uses suggestion to induce relaxation as well as beneficial modification of the way in which the patient experiences the gut working. In previous studies in our lab, we have shown that a single 50 minute session of hypnosis can reduce special indicators of inflammation both in the blood-stream and in the lining of the lower bowel (rectum). Furthermore, in earlier work by others, hypnosis had been shown to be effective in the treatment of patients with irritable bowel syndrome, duodenal ulcer and indigestion unassociated with ulcers. Many patients with UC need to take the immunosuppressive drug, azathioprine, in addition to a 5ASA drug, to keep their disease under control. While azathioprine is usually effective in maintaining remission of UC, it does require regular drug checks and carries the risk of possible side-effects. We undertook a study of hypnotherapy to see whether it can prevent relapse (worsening) of UC in patients who normally need to take azathioprine to keep their UC inactive. To do this, we planned to ask 66 patients who agreed to participate in the trial to stop their azathioprine. They were then to be allocated to receive either gut-focussed hypnotherapy (44 patients) or, as a control, non-emotive educational sessions (22 patients) once a month for 3 months, with intervening self-hypnosis daily in the active arm. The numbers of patients in each group who developed relapse of their UC in a year were recorded. We diagnosed relapse from patients' diaries recording diarrhoea and bleeding, and by sigmoidoscopy. It was hoped that this clinical trial would identify a new drug-free way of reducing the chances of relapse in patients with UC.

Conditions

Ulcerative Colitis

Keywords

Hypnotherapy; Prevention of relapse; ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Relapse at 1 Year

  The number of patients suffering a relapse was compared between the two treatment groups, and was the primary outcome parameter of this study.

  1 year

Secondary Outcomes (4)

• Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 13

  13 weeks

• Hospital Anxiety and Depression Score-Anxiety, (HADSA) at Week 13

  13 weeks

• Hospital Anxiety and Depression Score-Depression (HADSD)

  13 weeks

• Perceived Stress Questionnaire-Recent (PSQ-R)

  13 weeks

Study Arms (2)

Gut-focussed hypnotherapy (GFH).

ACTIVE COMPARATOR

Gut-focussed hypnotherapy (GFH).

Behavioral: Gut focussed hypnotherapy

Educational sessions

SHAM COMPARATOR

Regular sessions to learn about UC from research nurse

Behavioral: Control educational sessions

Interventions

Gut focussed hypnotherapy BEHAVIORAL

Gut focussed hypnotherapy

Gut-focussed hypnotherapy (GFH).

Control educational sessions BEHAVIORAL

Control educational sessions

Educational sessions

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Inactive UC
• Age 16-75 years
• Minimum 1 year on Azathioprine or Mercaptopurine.
• Simple Colitis Activity Index (SCCAI) score \<3
• Baron's sigmoidoscopic score \<2 .
• In remission for at least 3 months
• No change to other maintenance therapy (including 5ASA) for at least 4 months

You may not qualify if:

• Use of prednisolone orally or topically, or of topical 5ASA for at least 3 months Antibiotics, warfarin, anti-diarrhoeal drugs, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin \> 75 mg/day
• Herbal remedies
• Alcohol or drug abuse
• Pregnancy or breast feeding
• Female of child-bearing age not taking adequate contraception
• Participation in another drug trial in the previous three months
• Serious liver, renal, cardiac, respiratory, endocrine, neurological or psychiatric illness
• Already use relaxation techniques or computerized feedback

Sponsors & Collaborators

• Queen Mary University of London: lead
• Barts & The London NHS Trust: collaborator

Study Sites (3)

Barts and The Royal London NHS Trust/Queen Mary University London/

London, E1 1BB, United Kingdom

Location

University College Hospital London

London, NW1 2BU, United Kingdom

Location

Guy's and St Thomas' NHS Trust

London, SE1 7EH, United Kingdom

Location

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MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Prof D S Rampton
• Organization: Barts Health NHS Trust

d.rampton@qmul.ac.uk

+442035943300

Study Officials

• David S Rampton, MAFRCP DPhil

  Barts and the London/Queen Mary School of Medicine and Dentistry, London.

  PRINCIPAL INVESTIGATOR

• Anton Emmanuel, MBBS MD FRCP

  University College London Hospital, London

  PRINCIPAL INVESTIGATOR

• Louise Langmead, MBBS MD MRCP

  Univesity College London Hospital , London

  PRINCIPAL INVESTIGATOR

• Jeremy D Sanderson, MBBSFRCP MD

  Guy's and St Thomas'NHS Trust/King's College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 5, 2007
• Study Start: October 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 28, 2019
• Results First Posted: June 28, 2019

Record last verified: 2013-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)