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Unable to recruit sufficient numbers of patinets in the time available
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| Name | Class |
|---|---|
| Barts & The London NHS Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gut-focussed hypnotherapy (GFH). | Active Comparator | Gut-focussed hypnotherapy (GFH). |
|
| Educational sessions | Sham Comparator | Regular sessions to learn about UC from research nurse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gut focussed hypnotherapy | Behavioral | Gut focussed hypnotherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts and The Royal London NHS Trust/Queen Mary University London/ | London | E1 1BB | United Kingdom | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16162953 | Background | Mawdsley JE, Rampton DS. Psychological stress in IBD: new insights into pathogenic and therapeutic implications. Gut. 2005 Oct;54(10):1481-91. doi: 10.1136/gut.2005.064261. | |
| 14572569 | Background | Bitton A, Sewitch MJ, Peppercorn MA, deB Edwardes MD, Shah S, Ransil B, Locke SE. Psychosocial determinants of relapse in ulcerative colitis: a longitudinal study. Am J Gastroenterol. 2003 Oct;98(10):2203-8. doi: 10.1111/j.1572-0241.2003.07717.x. |
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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).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Gut-focussed Hypnotherapy (GFH) | Patients given gut-focussed hypnotherapy (GFH).after withdrawing from thiopurine |
| FG001 | Control Educational Sessions | Patients given control educational sessions after withdrawing from thiopurines |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Control educational sessions |
| Behavioral |
Control educational sessions |
|
| 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, | 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. | 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. | 13 weeks |
| University College Hospital London |
| London |
| NW1 2BU |
| United Kingdom |
| Guy's and St Thomas' NHS Trust | London | SE1 7EH | United Kingdom |
| 10811330 | Background | Levenstein S, Prantera C, Varvo V, Scribano ML, Andreoli A, Luzi C, Arca M, Berto E, Milite G, Marcheggiano A. Stress and exacerbation in ulcerative colitis: a prospective study of patients enrolled in remission. Am J Gastroenterol. 2000 May;95(5):1213-20. doi: 10.1111/j.1572-0241.2000.02012.x. |
| 2038047 | Background | Garrett VD, Brantley PJ, Jones GN, McKnight GT. The relation between daily stress and Crohn's disease. J Behav Med. 1991 Feb;14(1):87-96. doi: 10.1007/BF00844770. |
| 8155059 | Background | Greene BR, Blanchard EB, Wan CK. Long-term monitoring of psychosocial stress and symptomatology in inflammatory bowel disease. Behav Res Ther. 1994 Feb;32(2):217-26. doi: 10.1016/0005-7967(94)90114-7. |
| 16890594 | Background | Mawdsley JE, Macey MG, Feakins RM, Langmead L, Rampton DS. The effect of acute psychologic stress on systemic and rectal mucosal measures of inflammation in ulcerative colitis. Gastroenterology. 2006 Aug;131(2):410-9. doi: 10.1053/j.gastro.2006.05.017. |
| 16086717 | Background | Farhadi A, Keshavarzian A, Van de Kar LD, Jakate S, Domm A, Zhang L, Shaikh M, Banan A, Fields JZ. Heightened responses to stressors in patients with inflammatory bowel disease. Am J Gastroenterol. 2005 Aug;100(8):1796-804. doi: 10.1111/j.1572-0241.2005.50071.x. |
| 3094804 | Background | Ewer TC, Stewart DE. Improvement in bronchial hyper-responsiveness in patients with moderate asthma after treatment with a hypnotic technique: a randomised controlled trial. Br Med J (Clin Res Ed). 1986 Nov 1;293(6555):1129-32. doi: 10.1136/bmj.293.6555.1129. |
| 15832067 | Background | Langewitz W, Izakovic J, Wyler J, Schindler C, Kiss A, Bircher AJ. Effect of self-hypnosis on hay fever symptoms - a randomised controlled intervention study. Psychother Psychosom. 2005;74(3):165-72. doi: 10.1159/000084001. |
| 892940 | Background | Friedman H, Taub HA. The use of hypnosis and biofeedback procedures for essential hypertension. Int J Clin Exp Hypn. 1977 Oct;25(4):335-47. doi: 10.1080/00207147708415989. No abstract available. |
| 2675960 | Background | Horne DJ, White AE, Varigos GA. A preliminary study of psychological therapy in the management of atopic eczema. Br J Med Psychol. 1989 Sep;62(3):241-8. doi: 10.1111/j.2044-8341.1989.tb02832.x. |
| 3300566 | Background | Shertzer CL, Lookingbill DP. Effects of relaxation therapy and hypnotizability in chronic urticaria. Arch Dermatol. 1987 Jul;123(7):913-6. |
| 6150275 | Background | Whorwell PJ, Prior A, Faragher EB. Controlled trial of hypnotherapy in the treatment of severe refractory irritable-bowel syndrome. Lancet. 1984 Dec 1;2(8414):1232-4. doi: 10.1016/s0140-6736(84)92793-4. |
| 12003432 | Background | Gonsalkorale WM, Houghton LA, Whorwell PJ. Hypnotherapy in irritable bowel syndrome: a large-scale audit of a clinical service with examination of factors influencing responsiveness. Am J Gastroenterol. 2002 Apr;97(4):954-61. doi: 10.1111/j.1572-0241.2002.05615.x. |
| 12775355 | Background | Zijlstra FJ, van den Berg-de Lange I, Huygen FJ, Klein J. Anti-inflammatory actions of acupuncture. Mediators Inflamm. 2003 Apr;12(2):59-69. doi: 10.1080/0962935031000114943. |
| 14698357 | Background | Naito A, Laidlaw TM, Henderson DC, Farahani L, Dwivedi P, Gruzelier JH. The impact of self-hypnosis and Johrei on lymphocyte subpopulations at exam time: a controlled study. Brain Res Bull. 2003 Dec 30;62(3):241-53. doi: 10.1016/j.brainresbull.2003.09.014. |
| 11451479 | Background | Gruzelier J, Smith F, Nagy A, Henderson D. Cellular and humoral immunity, mood and exam stress: the influences of self-hypnosis and personality predictors. Int J Psychophysiol. 2001 Aug;42(1):55-71. doi: 10.1016/s0167-8760(01)00136-2. |
| 11550733 | Background | Kiecolt-Glaser JK, Marucha PT, Atkinson C, Glaser R. Hypnosis as a modulator of cellular immune dysregulation during acute stress. J Consult Clin Psychol. 2001 Aug;69(4):674-82. doi: 10.1037//0022-006x.69.4.674. |
| 8121979 | Background | Zachariae R, Hansen JB, Andersen M, Jinquan T, Petersen KS, Simonsen C, Zachariae C, Thestrup-Pedersen K. Changes in cellular immune function after immune specific guided imagery and relaxation in high and low hypnotizable healthy subjects. Psychother Psychosom. 1994;61(1-2):74-92. doi: 10.1159/000288872. |
| 12570090 | Background | Wood GJ, Bughi S, Morrison J, Tanavoli S, Tanavoli S, Zadeh HH. Hypnosis, differential expression of cytokines by T-cell subsets, and the hypothalamo-pituitary-adrenal axis. Am J Clin Hypn. 2003 Jan;45(3):179-96. doi: 10.1080/00029157.2003.10403525. |
| 1638191 | Background | Hawthorne AB, Logan RF, Hawkey CJ, Foster PN, Axon AT, Swarbrick ET, Scott BB, Lennard-Jones JE. Randomised controlled trial of azathioprine withdrawal in ulcerative colitis. BMJ. 1992 Jul 4;305(6844):20-2. doi: 10.1136/bmj.305.6844.20. |
| 9771402 | Background | Walmsley RS, Ayres RC, Pounder RE, Allan RN. A simple clinical colitis activity index. Gut. 1998 Jul;43(1):29-32. doi: 10.1136/gut.43.1.29. |
| 14075156 | Background | BARON JH, CONNELL AM, LENNARD-JONES JE. VARIATION BETWEEN OBSERVERS IN DESCRIBING MUCOSAL APPEARANCES IN PROCTOCOLITIS. Br Med J. 1964 Jan 11;1(5375):89-92. doi: 10.1136/bmj.1.5375.89. No abstract available. |
| 15647634 | Background | Gonsalkorale WM, Whorwell PJ. Hypnotherapy in the treatment of irritable bowel syndrome. Eur J Gastroenterol Hepatol. 2005 Jan;17(1):15-20. doi: 10.1097/00042737-200501000-00004. |
| 1876418 | Background | Toomey TC, Mann JD, Abashian S, Thompson-Pope S. Relationship between perceived self-control of pain, pain description and functioning. Pain. 1991 May;45(2):129-133. doi: 10.1016/0304-3959(91)90177-Y. |
| 7556809 | Background | Reynaert C, Janne P, Donckier J, Buysschaert M, Zdanowicz N, Lejeune D, Cassiers L. Locus of control and metabolic control. Diabete Metab. 1995 Jun;21(3):180-7. |
| 15929768 | Background | Velayos FS, Terdiman JP, Walsh JM. Effect of 5-aminosalicylate use on colorectal cancer and dysplasia risk: a systematic review and metaanalysis of observational studies. Am J Gastroenterol. 2005 Jun;100(6):1345-53. doi: 10.1111/j.1572-0241.2005.41442.x. |
| 11516052 | Background | Anbar RD. Self-hypnosis for the treatment of functional abdominal pain in childhood. Clin Pediatr (Phila). 2001 Aug;40(8):447-51. doi: 10.1177/000992280104000804. |
| 11781853 | Background | Conroy SP, Mayberry JF. Patient information booklets for Asian patients with ulcerative colitis. Public Health. 2001 Nov;115(6):418-20. doi: 10.1038/sj/ph/1900799. |
| 17029612 | Background | Maunder RG, Greenberg GR, Hunter JJ, Lancee WJ, Steinhart AH, Silverberg MS. Psychobiological subtypes of ulcerative colitis: pANCA status moderates the relationship between disease activity and psychological distress. Am J Gastroenterol. 2006 Nov;101(11):2546-51. doi: 10.1111/j.1572-0241.2006.00798.x. Epub 2006 Oct 4. |
| 939841 | Background | Wallston BS, Wallston KA, Kaplan GD, Maides SA. Development and validation of the health locus of control (HLC) scale. J Consult Clin Psychol. 1976 Aug;44(4):580-5. doi: 10.1037//0022-006x.44.4.580. No abstract available. |
| 16590342 | Background | Hilgard ER, Weitzenhoffer AM, Gough P. INDIVIDUAL DIFFERENCES IN SUSCEPTIBILITY TO HYPNOSIS. Proc Natl Acad Sci U S A. 1958 Dec 15;44(12):1255-9. doi: 10.1073/pnas.44.12.1255. No abstract available. |
| 2644154 | Background | Guyatt G, Mitchell A, Irvine EJ, Singer J, Williams N, Goodacre R, Tompkins C. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology. 1989 Mar;96(3):804-10. |
| 10889150 | Background | Tibble JA, Sigthorsson G, Bridger S, Fagerhol MK, Bjarnason I. Surrogate markers of intestinal inflammation are predictive of relapse in patients with inflammatory bowel disease. Gastroenterology. 2000 Jul;119(1):15-22. doi: 10.1053/gast.2000.8523. |
| 15913591 | Background | van Toorenenbergen AW, Oranje AP. Comparison of serum tryptase and urine N-methylhistamine in patients with suspected mastocytosis. Clin Chim Acta. 2005 Sep;359(1-2):72-7. doi: 10.1016/j.cccn.2005.03.041. |
| 16696804 | Background | Zocco MA, dal Verme LZ, Cremonini F, Piscaglia AC, Nista EC, Candelli M, Novi M, Rigante D, Cazzato IA, Ojetti V, Armuzzi A, Gasbarrini G, Gasbarrini A. Efficacy of Lactobacillus GG in maintaining remission of ulcerative colitis. Aliment Pharmacol Ther. 2006 Jun 1;23(11):1567-74. doi: 10.1111/j.1365-2036.2006.02927.x. |
| 16573787 | Background | Bergman R, Parkes M. Systematic review: the use of mesalazine in inflammatory bowel disease. Aliment Pharmacol Ther. 2006 Apr 1;23(7):841-55. doi: 10.1111/j.1365-2036.2006.02846.x. |
| Background | Shetty A, Kalantzis C, Polymeros D, Vega R, Abraham S, Forbes A. Hypnotherapy for inflammatory bowel disease- a randomised, placebo-controlled trial. Gut 2004;53:A226 |
| Background | Mawdsley JE, Jenkins D, Macey MG, Rampton DS. Natural Killer cells are increased by psychological stress and decreased by hypnotherapy in ulcerative colitis. Gut 2005; 54 (Suppl II): A23 |
| Background | Mawdsley JE, Jenkins D, Macey MG, Rampton DS. Hypnotherapy decreases rectal mucosal release of substance P, histamine and IL-13 in patients with active UC. Gut 2006; 55 (Suppl II): A75 |
| Background | Emmanuel AV, Storrie JB, Butcher L et al. Is targeting locus of control a desirable outcome of biofeedback in functional constipation ? Gut 2007;56, suppl 11:A63. |
| Background | Rampton DS, Shanahan S. Fast facts: Inflammatory Bowel Disease. Health Press, 2nd ed, 2006. |
| Background | Mawdsley JE, Rampton DS. Serum IL-13 concentrations are raised in active ulcerative colitis and correlate with disease activity and mucosal inflammation. Gut 2005; 54 (Suppl IV): A165 |
| 40243391 | Derived | Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3. |
| COMPLETED |
|
| NOT COMPLETED |
|
Patients with inactive UC withdrawing from thiopurines
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gut-focussed Hypnotherapy | 16 Patients with inactive ulcerative colitis given gut-focussed hypnotherapy |
| BG001 | Controlled Educational Sessions | 10 Patients with inactive ulcerative colitis given educational sessions |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of subjects in years, 22-65 years | Median | Full Range | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 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. | Patients all assessed at 13 weeks (end of treatment phase). 4 hypnotherapy and 1 control patient failed to complete their questionnaires | Posted | Median | Full Range | units on a scale | 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, | 4 hypnotherapy and 1 control patient failed to complete their questionnaires | Posted | Median | Full Range | score on a scale | 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. | 4 hypnotherapy and 1 control patient failed to complete their questionnaires | Posted | Median | Full Range | units on a scale | 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. | 4 hypnotherapy and 1 control patient failed to complete their questionnaires | Posted | Median | Full Range | units on a scale | 13 weeks |
|
|
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gut-focussed Hypnotherapy (GFH) | Patients given gut-focussed hypnotherapy (GFH).after withdrawing from thiopurine. No adverse events apart from relapse | 0 | 16 | 0 | 16 | 0 | 16 |
| EG001 | Controlled Educational Sessions | Patients given controlled educational sessions after withdrawing from thiopurines No adverse events apart from relapse | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof D S Rampton | Barts Health NHS Trust | +442035943300 | d.rampton@qmul.ac.uk |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| Male |
|
| Participants |
|
|
|
|
|
|
|