- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04523311
An Evaluation of Brief Online Hypnosis for Migraine and Tension-type Headaches
July 26, 2021 updated by: Canterbury Christ Church University
This study aims to conduct an initial evaluation of whether a single, online, group-based session of hypnosis followed by self-hypnosis can decrease symptoms of migraine and tension-type headaches as well as improve quality of life and perceived self-efficacy over the condition.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a pilot randomised controlled trial (RCT) comparing a single, online, group-based session of hypnosis followed by self-hypnosis for people with migraines or tension-type headaches with a wait-list control.
A battery of self-report measures and a 2-week headache diary will be administered online at baseline (weeks 0 and 1), post-intervention (weeks 7 and 8) and at follow-up (weeks 11 and 12).
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tunbridge Wells, United Kingdom
- Salomons Institute for Applied Psychology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Self-reported diagnosis of migraine or tension-type headaches from a General Practitioner (i.e. family physician) and/or specialist physician.
- Score above the cut-off for either migraine or tension-type headache on the Headache Screening Questionnaire.
- Have experienced at least one headache every two weeks over the last 3 months.
- Otherwise healthy physically and mentally.
- Able to understand written and spoken English.
- Have the IT equipment necessary to access Zoom videoconferencing and the Qualtrics survey system.
Exclusion Criteria:
- Substantial medical or psychiatric co-morbidities including diagnoses of epilepsy, psychosis or personality disorder, and/or taking psychiatric medication.
- A diagnosis of medication overuse headache.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Hypnosis + usual care
An online, group-based, single session hypnosis workshop followed by 2 weeks of self hypnosis.
Participants will continue with whatever usual care they receive/undertake.
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Online, group-based, single session hypnosis workshop followed by 2 weeks of self hypnosis.
Participants will be asked to continue with whatever interventions they are already receiving/employing to manage their migraine and tension-type headaches.
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OTHER: Waitlist control + usual care
The control group will receive no intervention beyond whatever usual care they receive/undertake.
After the study is complete, they will be offered the option of participating in the hypnosis intervention.
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Participants will be asked to continue with whatever interventions they are already receiving/employing to manage their migraine and tension-type headaches.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline at 7-8 weeks in mean headache rating averaged over 2 weeks of headache diary entries.
Time Frame: Post intervention (weeks 7-8)
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At baseline (weeks 0-1) and post-intervention (weeks 7-8), participants will complete a headache diary for two weeks.
The diary comprises hourly ratings of headache intensity (during waking hours) on a 0-5 scale, with higher scores indicating greater migraine/tension-type headache symptom burden.
The mean rating over two weeks is used.
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Post intervention (weeks 7-8)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline at 11-12 weeks in mean headache rating averaged over 2 weeks of headache diary entries.
Time Frame: Follow-up (weeks 11-12)
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As described in the primary outcome.
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Follow-up (weeks 11-12)
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Change from baseline at 7-8 weeks in headache frequency over 2 weeks of headache diary entries.
Time Frame: Post intervention (weeks 7-8)
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Using the aforementioned headache diary, the frequency of headaches over the 2 week diary period will be calculated.
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Post intervention (weeks 7-8)
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Change from baseline at 11-12 weeks in headache frequency over 2 weeks of headache diary entries.
Time Frame: Follow-up (weeks 11-12)
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Using the aforementioned headache diary, the frequency of headaches over the 2 week diary period will be calculated.
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Follow-up (weeks 11-12)
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Change from baseline at 7-8 weeks in mean headache duration over 2 weeks of headache diary entries.
Time Frame: Post intervention (weeks 7-8)
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Using the aforementioned headache diary, the mean duration of headaches over the 2 week diary period will be calculated.
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Post intervention (weeks 7-8)
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Change from baseline at 11-12 weeks in mean headache duration over 2 weeks of headache diary entries.
Time Frame: Follow-up (weeks 11-12)
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Using the aforementioned headache diary, the mean duration of headaches over the 2 week diary period will be calculated.
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Follow-up (weeks 11-12)
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Change from baseline at week 7 on the Depression, Anxiety and Stress Scales - 21 item version (DASS-21)
Time Frame: Post intervention (week 7)
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This measures symptoms of depression, anxiety and stress producing a score between 0 and 63, with higher scores indicating greater symptomatology.
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Post intervention (week 7)
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Change from baseline at week 11 on the Depression, Anxiety and Stress Scales - 21 item version (DASS-21)
Time Frame: Follow-up (week 11)
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This measures symptoms of depression, anxiety and stress producing a score between 0 and 63, with higher scores indicating greater symptomatology.
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Follow-up (week 11)
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Change from baseline at week 7 on the Warwick-Edinburgh Mental Wellbeing (WEMWBS) Scale
Time Frame: Post intervention (week 7)
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This measures psychological wellbeing, producing a score between 15 and 75, with higher scores indicating greater wellbeing.
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Post intervention (week 7)
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Change from baseline at week 11 on the Warwick-Edinburgh Mental Wellbeing (WEMWBS) Scale
Time Frame: Follow-up (week 11)
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This measures psychological wellbeing, producing a score between 15 and 75, with higher scores indicating greater wellbeing.
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Follow-up (week 11)
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Change from baseline at week 7 on the Headache-Specific Locus of Control Scale (HSLC).
Time Frame: Post intervention (week 7)
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This measures one's sense of locus of control over headaches, producing a score between 33 and 165, with higher scores indicating more external perceived locus of control.
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Post intervention (week 7)
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Change from baseline at week 11 on the Headache-Specific Locus of Control Scale (HSLC).
Time Frame: Follow-up (week 11)
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This measures one's sense of locus of control over headaches, producing a score between 33 and 165, with higher scores indicating more external perceived locus of control.
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Follow-up (week 11)
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Change from baseline at week 7 on the Headache Management Self-efficacy Scale (HMSE).
Time Frame: Post intervention (week 7)
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This measures headache management self-efficacy, producing a score between 25 and 175, with higher scores indicating greater perceived self-efficacy over headache self-management.
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Post intervention (week 7)
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Change from baseline at week 11 on the Headache Management Self-efficacy Scale (HMSE).
Time Frame: Follow-up (week 11)
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This measures headache management self-efficacy, producing a score between 25 and 175, with higher scores indicating greater perceived self-efficacy over headache self-management.
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Follow-up (week 11)
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Change from baseline at 7-8 weeks in headache related medication consumption over a two week period.
Time Frame: Post intervention (weeks 7-8)
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At baseline (weeks 0-1) and post-intervention (weeks 7-8), participants will keep a diary of their daily, headache-related medication consumption over a two week period.
From this, changes in type, dose and frequency of medication will be calculated.
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Post intervention (weeks 7-8)
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Change from baseline at 11-12 weeks in headache related medication consumption over a two week period.
Time Frame: Follow-up (weeks 11-12)
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At baseline (weeks 0-1) and follow-up (weeks 11-12), participants will keep a diary of their daily, headache-related medication consumption over a two week period.
From this, changes in type, dose and frequency of medication will be calculated.
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Follow-up (weeks 11-12)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline scores on the Credibility/Expectancy of Change Questionnaire will moderate the primary and secondary outcomes.
Time Frame: Baseline (week 0)
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This questionnaire measures how much people believe the therapy will help improve lifestyle and functioning prior to the start of the therapy, producing a score between 0 and 21, with higher scores indicating greater treatment credibility and expectancy for change.
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Baseline (week 0)
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Baseline scores on the Attitudes Towards Hypnosis scale will moderate the primary and secondary outcomes specified above.
Time Frame: Baseline (week 0)
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This scale measures how much people believe hypnosis can be helpful, producing a score between 13 and 91, with higher scores indicating greater belief in the efficacy of hypnosis.
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Baseline (week 0)
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Week 2 scores of a bespoke measure of hypnotic suggestibility will predict the degree of change in the primary and secondary outcomes specified above [this applies to the intervention group only].
Time Frame: Within the online, group-based intervention session (week 2).
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This bespoke measure will be administered in the online, group-based hypnosis session and will measure intervention participants' suggestibility, producing a score from 0 to 50, with higher scores indicating greater suggestibility.
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Within the online, group-based intervention session (week 2).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Paul Davies, MSc, Canterbury Christ Church University
- Study Director: Robert Agnew, DClinPsych, Private Practice
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 27, 2020
Primary Completion (ACTUAL)
February 24, 2021
Study Completion (ACTUAL)
February 24, 2021
Study Registration Dates
First Submitted
August 19, 2020
First Submitted That Met QC Criteria
August 19, 2020
First Posted (ACTUAL)
August 21, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 27, 2021
Last Update Submitted That Met QC Criteria
July 26, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PaulDavies2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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