MigraineNCT04523311
An Evaluation of Brief Online Hypnosis for Migraine and Tension-type Headaches
A study testing Hypnosis. in people with Migraine and Tension-Type Headache, run by Canterbury Christ Church University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Migraine, Tension-Type Headache
- What is being tested?
- Hypnosis.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Oct 2020to 24 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Salomons Institute for Applied Psychology
Royal Tunbridge Wells
About this study
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.
Read the 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).
- Conditions
- Migraine, Tension-Type Headache
- Being tested
- Hypnosis., Usual care
- Medical subject headings
- Migraine Disorders, Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnosis.Behavioural
Online, group-based, single session hypnosis workshop followed by 2 weeks of self hypnosis.
Usual careOther
Participants will be asked to continue with whatever interventions they are already receiving/employing to manage their migraine and tension-type headaches.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis + usual care | Experimental | 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. Receives: Behavioral: Hypnosis.; Other: Usual care |
| Waitlist control + usual care | Other | 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at 7-8 weeks in mean headache rating averaged over 2 weeks of headache diary entries.
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.
Measured: Post intervention (weeks 7-8)
Secondary outcomes (15)
Change from baseline at 11-12 weeks in mean headache rating averaged over 2 weeks of headache diary entries.
As described in the primary outcome.
Measured: Follow-up (weeks 11-12)
Change from baseline at 7-8 weeks in headache frequency over 2 weeks of headache diary entries.
Using the aforementioned headache diary, the frequency of headaches over the 2 week diary period will be calculated.
Measured: Post intervention (weeks 7-8)
Change from baseline at 11-12 weeks in headache frequency over 2 weeks of headache diary entries.
Using the aforementioned headache diary, the frequency of headaches over the 2 week diary period will be calculated.
Measured: Follow-up (weeks 11-12)
Change from baseline at 7-8 weeks in mean headache duration over 2 weeks of headache diary entries.
Using the aforementioned headache diary, the mean duration of headaches over the 2 week diary period will be calculated.
Measured: Post intervention (weeks 7-8)
Change from baseline at 11-12 weeks in mean headache duration over 2 weeks of headache diary entries.
Using the aforementioned headache diary, the mean duration of headaches over the 2 week diary period will be calculated.
Measured: Follow-up (weeks 11-12)
Change from baseline at week 7 on the Depression, Anxiety and Stress Scales - 21 item version (DASS-21)
This measures symptoms of depression, anxiety and stress producing a score between 0 and 63, with higher scores indicating greater symptomatology.
Measured: Post intervention (week 7)
Change from baseline at week 11 on the Depression, Anxiety and Stress Scales - 21 item version (DASS-21)
This measures symptoms of depression, anxiety and stress producing a score between 0 and 63, with higher scores indicating greater symptomatology.
Measured: Follow-up (week 11)
Change from baseline at week 7 on the Warwick-Edinburgh Mental Wellbeing (WEMWBS) Scale
This measures psychological wellbeing, producing a score between 15 and 75, with higher scores indicating greater wellbeing.
Measured: Post intervention (week 7)
Change from baseline at week 11 on the Warwick-Edinburgh Mental Wellbeing (WEMWBS) Scale
This measures psychological wellbeing, producing a score between 15 and 75, with higher scores indicating greater wellbeing.
Measured: Follow-up (week 11)
Change from baseline at week 7 on the Headache-Specific Locus of Control Scale (HSLC).
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.
Measured: Post intervention (week 7)
Change from baseline at week 11 on the Headache-Specific Locus of Control Scale (HSLC).
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.
Measured: Follow-up (week 11)
Change from baseline at week 7 on the Headache Management Self-efficacy Scale (HMSE).
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.
Measured: Post intervention (week 7)
Change from baseline at week 11 on the Headache Management Self-efficacy Scale (HMSE).
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.
Measured: Follow-up (week 11)
Change from baseline at 7-8 weeks in headache related medication consumption over a two week period.
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.
Measured: Post intervention (weeks 7-8)
Change from baseline at 11-12 weeks in headache related medication consumption over a two week period.
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.
Measured: Follow-up (weeks 11-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start27 Oct 2020
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Davies, MSc, Principal investigator, Canterbury Christ Church UniversityFergal Jones, PhD, PsychD, Study director, Canterbury Christ Church UniversityRobert Agnew, DClinPsych, Study director, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523311
- Sponsor's protocol ID
- PaulDavies2020
- Status last verified
- Jul 2021
- First submitted
- 19 Aug 2020
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Brief Online Hypnosis for Migraine and Tension-type Headaches
- ClinicalTrials.gov ID
- NCT04523311
- Acronym / sponsor ID
- PaulDavies2020
- Conditions
- Migraine, Tension-Type Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis + usual care | Experimental | Behavioral: Hypnosis., Other: Usual careAn online, group-based, single session hypnosis workshop followed by 2 weeks of self hypnosis. Participants will continue with whatever usual care they receive/undertake. |
| Waitlist control + usual care | Other | Other: Usual careThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Hypnosis.Online, group-based, single session hypnosis workshop followed by 2 weeks of self hypnosis. | Behavioural | Hypnosis + usual care |
| Usual careParticipants will be asked to continue with whatever interventions they are already receiving/employing to manage their migraine and tension-type headaches. | Other | Hypnosis + usual care, Waitlist control + usual care |
Primary outcome
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)
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.
15 secondary outcomes
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)
Change from baseline at 7-8 weeks in headache frequency over 2 weeks of headache diary entries.
Time frame: Post intervention (weeks 7-8)
Change from baseline at 11-12 weeks in headache frequency over 2 weeks of headache diary entries.
Time frame: Follow-up (weeks 11-12)
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)
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)
Change from baseline at week 7 on the Depression, Anxiety and Stress Scales - 21 item version (DASS-21)
Time frame: Post intervention (week 7)
Change from baseline at week 11 on the Depression, Anxiety and Stress Scales - 21 item version (DASS-21)
Time frame: Follow-up (week 11)
Change from baseline at week 7 on the Warwick-Edinburgh Mental Wellbeing (WEMWBS) Scale
Time frame: Post intervention (week 7)
Change from baseline at week 11 on the Warwick-Edinburgh Mental Wellbeing (WEMWBS) Scale
Time frame: Follow-up (week 11)
Change from baseline at week 7 on the Headache-Specific Locus of Control Scale (HSLC).
Time frame: Post intervention (week 7)
Change from baseline at week 11 on the Headache-Specific Locus of Control Scale (HSLC).
Time frame: Follow-up (week 11)
Change from baseline at week 7 on the Headache Management Self-efficacy Scale (HMSE).
Time frame: Post intervention (week 7)
Change from baseline at week 11 on the Headache Management Self-efficacy Scale (HMSE).
Time frame: Follow-up (week 11)
Change from baseline at 7-8 weeks in headache related medication consumption over a two week period.
Time frame: Post intervention (weeks 7-8)
Change from baseline at 11-12 weeks in headache related medication consumption over a two week period.
Time frame: Follow-up (weeks 11-12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
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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.
Paul Davies, MSc principal investigator
Canterbury Christ Church University
Fergal Jones, PhD, PsychD study director
Canterbury Christ Church University
Robert Agnew, DClinPsych study director
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis. in people with Migraine and Tension-Type Headache, run by Canterbury Christ Church University at 1 site 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2021.