Trial Outcomes & Findings for Hypnotherapy for Prevention of Relapse in Ulcerative Colitis: a Randomised, Single-blind, Controlled Clinical Trial (NCT NCT00553163)
NCT ID: NCT00553163
Last Updated: 2019-06-28
Results Overview
The number of patients suffering a relapse was compared between the two treatment groups, and was the primary outcome parameter of this study.
TERMINATED
NA
26 participants
1 year
2019-06-28
Participant Flow
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).
Participant milestones
| Measure |
Gut-focussed Hypnotherapy (GFH)
Patients given gut-focussed hypnotherapy (GFH).after withdrawing from thiopurine
|
Control Educational Sessions
Patients given control educational sessions after withdrawing from thiopurines
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
10
|
|
Overall Study
COMPLETED
|
16
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hypnotherapy for Prevention of Relapse in Ulcerative Colitis: a Randomised, Single-blind, Controlled Clinical Trial
Baseline characteristics by cohort
| Measure |
Gut-focussed Hypnotherapy
n=16 Participants
16 Patients with inactive ulcerative colitis given gut-focussed hypnotherapy
|
Controlled Educational Sessions
n=10 Participants
10 Patients with inactive ulcerative colitis given educational sessions
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
n=93 Participants
|
48 years
n=4 Participants
|
35 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
16 participants
n=93 Participants
|
10 participants
n=4 Participants
|
26 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe number of patients suffering a relapse was compared between the two treatment groups, and was the primary outcome parameter of this study.
Outcome measures
| Measure |
UC Patients Given Gut-focussed Hypnotherapy
n=16 Participants
Gut-focussed hypnotherapy (GFH). Subjects were seen at 6 face-to-face visits in the 13 week treatment period (weeks 1, 2, 3, 5, 9 and 13).
|
UC Patients Given Control Educational Sessions
n=10 Participants
Controlled educational sessions:Subjects were seen at 4-weekly intervals (a total of 4 face-to-face visits in the 13 week treatment, at weeks 1, 5, 9 and 13),
|
|---|---|---|
|
Relapse at 1 Year
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Patients all assessed at 13 weeks (end of treatment phase). 4 hypnotherapy and 1 control patient failed to complete their questionnaires
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.
Outcome measures
| Measure |
UC Patients Given Gut-focussed Hypnotherapy
n=12 Participants
Gut-focussed hypnotherapy (GFH). Subjects were seen at 6 face-to-face visits in the 13 week treatment period (weeks 1, 2, 3, 5, 9 and 13).
|
UC Patients Given Control Educational Sessions
n=9 Participants
Controlled educational sessions:Subjects were seen at 4-weekly intervals (a total of 4 face-to-face visits in the 13 week treatment, at weeks 1, 5, 9 and 13),
|
|---|---|---|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 13
|
195 units on a scale
Interval 114.0 to 212.0
|
192 units on a scale
Interval 170.0 to 212.0
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: 4 hypnotherapy and 1 control patient failed to complete their questionnaires
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,
Outcome measures
| Measure |
UC Patients Given Gut-focussed Hypnotherapy
n=12 Participants
Gut-focussed hypnotherapy (GFH). Subjects were seen at 6 face-to-face visits in the 13 week treatment period (weeks 1, 2, 3, 5, 9 and 13).
|
UC Patients Given Control Educational Sessions
n=9 Participants
Controlled educational sessions:Subjects were seen at 4-weekly intervals (a total of 4 face-to-face visits in the 13 week treatment, at weeks 1, 5, 9 and 13),
|
|---|---|---|
|
Hospital Anxiety and Depression Score-Anxiety, (HADSA) at Week 13
|
7 score on a scale
Interval 3.0 to 11.0
|
10 score on a scale
Interval 4.0 to 14.0
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: 4 hypnotherapy and 1 control patient failed to complete their questionnaires
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.
Outcome measures
| Measure |
UC Patients Given Gut-focussed Hypnotherapy
n=12 Participants
Gut-focussed hypnotherapy (GFH). Subjects were seen at 6 face-to-face visits in the 13 week treatment period (weeks 1, 2, 3, 5, 9 and 13).
|
UC Patients Given Control Educational Sessions
n=9 Participants
Controlled educational sessions:Subjects were seen at 4-weekly intervals (a total of 4 face-to-face visits in the 13 week treatment, at weeks 1, 5, 9 and 13),
|
|---|---|---|
|
Hospital Anxiety and Depression Score-Depression (HADSD)
|
1.5 units on a scale
Interval 0.0 to 8.0
|
4 units on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: 4 hypnotherapy and 1 control patient failed to complete their questionnaires
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.
Outcome measures
| Measure |
UC Patients Given Gut-focussed Hypnotherapy
n=12 Participants
Gut-focussed hypnotherapy (GFH). Subjects were seen at 6 face-to-face visits in the 13 week treatment period (weeks 1, 2, 3, 5, 9 and 13).
|
UC Patients Given Control Educational Sessions
n=9 Participants
Controlled educational sessions:Subjects were seen at 4-weekly intervals (a total of 4 face-to-face visits in the 13 week treatment, at weeks 1, 5, 9 and 13),
|
|---|---|---|
|
Perceived Stress Questionnaire-Recent (PSQ-R)
|
0.3 units on a scale
Interval 0.1 to 0.6
|
0.4 units on a scale
Interval 0.1 to 0.7
|
Adverse Events
Gut-focussed Hypnotherapy (GFH)
Controlled Educational Sessions
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place