An interventional study of Gut focussed hypnotherapy and Control educational sessions in Ulcerative Colitis, sponsored by Queen Mary University of London. Terminated at 3 sites in United Kingdom. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-06-28.
Sponsored by Queen Mary University of London · Not applicable, Interventional, and Treatment
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.
SCIENTIFIC ABSTRACT There is increasing evidence that relapse of ulcerative colitis (UC) can be provoked by psychological stress. When this study was planned, there were 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 had shown that a single session of hypnosis can reduce measures of inflammation at both systemic and rectal mucosal levels. Thus, 50 min of gut-focussed hypnosis reduced serum interleukin-6 (IL6) and non-killer (NK) cell numbers in circulating blood, as well as rectal mucosal release of interleukin-13 (IL13), substance P and histamine. 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, azathioprine, in addition to a 5ASA, to keep their disease in remission. 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 could prevent relapse 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. We then recorded relapse rates in each group at 1 year. We diagnosed relapse from patients' diaries recording the Simple Clinical Activity Index, and by Baron score >1 at 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 withdrawing from treatment with azathioprine.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 26 is below the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Queen Mary University of London is the lead sponsor of 250 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Gut-focussed hypnotherapy (GFH).
Behavioral: Gut focussed hypnotherapy
Regular sessions to learn about UC from research nurse
Behavioral: Control educational sessions
Gut focussed hypnotherapy
Control educational sessions
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.
Time frame: 1 year
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.
Time frame: 13 weeks
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,
Time frame: 13 weeks
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.
Time frame: 13 weeks
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.
Time frame: 13 weeks
We aimed to recruit 66 patients from across London, but after \>3 years could recruit only 26. Reasons for failure to complete recruitment included the relative rarity of this patient-group (ie with inactive ulcerative colitis (UC) for some years while on thiopurine, willing to stop the drug, and with time to complete the intensive programme).
| Milestone | Gut-focussed Hypnotherapy (GFH) | Control Educational Sessions |
|---|---|---|
| Started | 16 | 10 |
| Completed | 16 | 10 |
| Not completed | 0 | 0 |
The number of patients suffering a relapse was compared between the two treatment groups, and was the primary outcome parameter of this study.
| Participants | UC Patients Given Gut-focussed Hypnotherapy | UC Patients Given Control Educational Sessions |
|---|---|---|
| Relapse at 1 Year | 8 | 7 |
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.
| units on a scale | UC Patients Given Gut-focussed Hypnotherapy | UC Patients Given Control Educational Sessions |
|---|---|---|
| Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 13 | 195 (114 to 212) | 192 (170 to 212) |
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,
| score on a scale | UC Patients Given Gut-focussed Hpynotherapy | UC Patients Given Control Educational Sessions |
|---|---|---|
| Hospital Anxiety and Depression Score-Anxiety, (HADSA) at Week 13 | 7 (3 to 11) | 10 (4 to 14) |
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.
| units on a scale | UC Patients Given Gut-focussed Hypnotherapy | UC Patients Given Control Educational Sessions |
|---|---|---|
| Hospital Anxiety and Depression Score-Depression (HADSD) | 1.5 (0 to 8) | 4 (0 to 8) |
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.
| units on a scale | UC Patients Given Gut-focussed Hypnotherapy | UC Patients Given Control Educational Sessions |
|---|---|---|
| Perceived Stress Questionnaire-Recent (PSQ-R) | 0.3 (0.1 to 0.6) | 0.4 (0.1 to 0.7) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gut-focussed Hypnotherapy (GFH) | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Controlled Educational Sessions | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
Patients with inactive UC withdrawing from thiopurines
| Age, Continuous(years) | Gut-focussed Hypnotherapy | Controlled Educational Sessions | Total |
|---|---|---|---|
| Median | 31 (22 to 65) | 48 (29 to 63) | 35 (22 to 65) |
| Sex: Female, Male(Participants) | Gut-focussed Hypnotherapy | Controlled Educational Sessions | Total |
|---|---|---|---|
| Female | 8 | 3 | 11 |
| Male | 8 | 7 | 15 |
| Region of Enrollment(participants) | Gut-focussed Hypnotherapy | Controlled Educational Sessions | Total |
|---|---|---|---|
| United Kingdom | 16 | 10 | 26 |
Plan to share: No
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Queen Mary University of London