Ulcerative Colitis Clinical Trial
Official title:
Hypnotherapy for Prevention of Relapse in Ulcerative Colitis: a Randomised, Single-blind, Controlled Clinical Trial
Verified date | November 2013 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 26 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Barts and The Royal London NHS Trust/Queen Mary University London/ | London | |
United Kingdom | Guy's and St Thomas' NHS Trust | London | |
United Kingdom | University College Hospital London | London |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London | Barts & The London NHS Trust |
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* Note: There are 43 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 13 | IBDQ (standard measure of IBD patients' Quality of life (QoL) (Irvine et al 1982 approx). The IBDQ is a validated and reliable tool to measure of health-related quality of life in adult patients with IBD. The questionnaire consists of 32 questions scored in four domains: bowel symptoms, emotional health, systemic systems and social function. Scores range from 1 (poorest QoL) to 7 (best QoL). Higher scores indicate better QoL. Lowest score 7, highest score 224. | 13 weeks | |
Secondary | Hospital Anxiety and Depression Score-Anxiety, (HADSA) at Week 13 | Measure of anxiety, HADS Hospital anxiety and depression scale. HADS questionnaire consists of a 14 question validated questionnaire, developed to measure anxiety and depression in the hospital setting. Each item is answered by the patient on a four point (0-3) response category so the possible scores range from 0 (minimum) to 21 (maximum) for anxiety and 0 (minimum) to 21 (maximum) for depression. Higher scores indicate worse outcome, | 13 weeks | |
Secondary | Hospital Anxiety and Depression Score-Depression (HADSD) | Measure of depression. Each item is answered by the patient on a four point (0-3) response category so the possible scores range from 0 to 21 for anxiety and 0 to 21 for depression. Each item is answered by the patient on a four point (0-3) response category so the possible scores range from 0 (minimum) to 21 (maximum) for anxiety and (minimum) to 21 (maximum) for depression. Higher scores worse outcome. | 13 weeks | |
Secondary | Perceived Stress Questionnaire-Recent (PSQ-R) | Measure of recent psychological stress. THE PSQ R consists of a 30 question questionnaires: recent, in which the statements used apply to the last month in which used statements apply to the last two years (Appendix 1.3). The score for both recent and general stress levels were stated as the PSQ index ranging from 0 (non-stressed) to 0.99 (highly stressed). Higher scores indicate worse outcome. | 13 weeks |
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