Ulcerative ColitisNCT00553163
Hypnotherapy for Prevention of Relapse in Ulcerative Colitis: a Randomised, Single-blind, Controlled Clinical Trial
A study testing Gut focussed hypnotherapy in people with Ulcerative Colitis, run by Queen Mary University of London at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Gut focussed hypnotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Oct 2007to Apr 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Barts and The Royal London NHS Trust/Queen Mary University London/
London, E1 1BB
University College Hospital London
London, NW1 2BU
Guy's and St Thomas' NHS Trust
London, SE1 7EH
About this study
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.
Read the detailed description
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.
- Conditions
- Ulcerative Colitis
- Being tested
- Gut focussed hypnotherapy, Control educational sessions
- Keywords
- Hypnotherapy, Prevention of relapse, ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gut focussed hypnotherapyBehavioural
Gut focussed hypnotherapy
Control educational sessionsBehavioural
Control educational sessions
| Study group | Role | What they receive |
|---|---|---|
| Gut-focussed hypnotherapy (GFH). | Active comparator | Gut-focussed hypnotherapy (GFH). Receives: Behavioral: Gut focussed hypnotherapy |
| Educational sessions | Sham comparator | Regular sessions to learn about UC from research nurse Receives: Behavioral: Control educational sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 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,
Measured: 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.
Measured: 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.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Unable to recruit sufficient numbers of patinets in the time available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Barts & The London NHS Trust
- Responsible party
- Sponsor
- Investigators
- David S Rampton, MAFRCP DPhil, Principal investigator, Barts and the London/Queen Mary School of Medicine and Dentistry, London.Anton Emmanuel, MBBS MD FRCP, Principal investigator, University College London Hospital, LondonLouise Langmead, MBBS MD MRCP, Principal investigator, Univesity College London Hospital , LondonJeremy D Sanderson, MBBSFRCP MD, Principal investigator, Guy's and St Thomas'NHS Trust/King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553163
- Sponsor's protocol ID
- BMRP proposal no IBD 0213
- Status last verified
- Nov 2013
- First submitted
- 2 Nov 2007
- Last updated
- 28 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 16162953Bitton 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.
PubMed 14572569Levenstein 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.
PubMed 10811330Garrett 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.
PubMed 2038047Greene 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.
PubMed 8155059Mawdsley 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.
PubMed 16890594Farhadi 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.
PubMed 16086717Ewer 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.
PubMed 3094804Langewitz 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.
PubMed 15832067Friedman 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.
PubMed 892940Horne 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.
PubMed 2675960Shertzer CL, Lookingbill DP. Effects of relaxation therapy and hypnotizability in chronic urticaria. Arch Dermatol. 1987 Jul;123(7):913-6.
PubMed 3300566Whorwell 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.
PubMed 6150275Gonsalkorale 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.
PubMed 12003432Zijlstra 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.
PubMed 12775355
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnotherapy for Prevention of Relapse in Ulcerative Colitis: a Randomised, Single-blind, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00553163
- Acronym / sponsor ID
- BMRP proposal no IBD 0213
- Conditions
- Ulcerative Colitis
- Keywords
- Hypnotherapy, Prevention of relapse, ulcerative colitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit sufficient numbers of patinets in the time available
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Barts & The London NHS Trust
- Study start
- Oct 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 5 Nov 2007 (estimated)
- Results
- Posted 28 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gut-focussed hypnotherapy (GFH). | Active comparator | Behavioral: Gut focussed hypnotherapyGut-focussed hypnotherapy (GFH). |
| Educational sessions | Sham comparator | Behavioral: Control educational sessionsRegular sessions to learn about UC from research nurse |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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 .
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gut focussed hypnotherapyGut focussed hypnotherapy | Behavioural | Gut-focussed hypnotherapy (GFH). |
| Control educational sessionsControl educational sessions | Behavioural | Educational sessions |
Primary outcome
Relapse at 1 Year
Time frame: 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.
4 secondary outcomes
Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 13
Time frame: 13 weeks
Hospital Anxiety and Depression Score-Anxiety, (HADSA) at Week 13
Time frame: 13 weeks
Hospital Anxiety and Depression Score-Depression (HADSD)
Time frame: 13 weeks
Perceived Stress Questionnaire-Recent (PSQ-R)
Time frame: 13 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16162953Mawdsley 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.
- Background: PubMed 14572569Bitton 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.
- Background: PubMed 10811330Levenstein 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.
- Background: PubMed 2038047Garrett 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.
- Background: PubMed 8155059Greene 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.
- Background: PubMed 16890594Mawdsley 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.
- Background: PubMed 16086717Farhadi 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.
- Background: PubMed 3094804Ewer 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.
- Background: PubMed 15832067Langewitz 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.
- Background: PubMed 892940Friedman 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.
- Background: PubMed 2675960Horne 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.
- Background: PubMed 3300566Shertzer CL, Lookingbill DP. Effects of relaxation therapy and hypnotizability in chronic urticaria. Arch Dermatol. 1987 Jul;123(7):913-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Rampton, MAFRCP DPhil principal investigator
Barts and the London/Queen Mary School of Medicine and Dentistry, London.
Anton Emmanuel, MBBS MD FRCP principal investigator
University College London Hospital, London
Louise Langmead, MBBS MD MRCP principal investigator
Univesity College London Hospital , London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gut focussed hypnotherapy in people with Ulcerative Colitis, run by Queen Mary University of London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse at 1 Year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00553163, which also lists 44 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.