An Evaluation of Brief Online Hypnosis for Migraine and Tension-type Headaches

Study Overview
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Brief Summary
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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
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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).

Official Title
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An Evaluation of Brief Online Hypnosis for Migraine and Tension-type Headaches

Conditions
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Migraine, Tension-Type Headache

Intervention / Treatment
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* Behavioral: Hypnosis.
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis + usual care<br>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. | Behavioral: Hypnosis.<br>* Online, group-based, single session hypnosis workshop followed by 2 weeks of self hypnosis.<br>Other: Usual care<br>* Participants will be asked to continue with whatever interventions they are already receiving/employing to manage their migraine and tension-type headaches.<br>|
| Other: Waitlist control + usual care<br>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. | Other: Usual care<br>* Participants will be asked to continue with whatever interventions they are already receiving/employing to manage their migraine and tension-type headaches.<br>|

What is the study measuring?
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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. | 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. | Post intervention (weeks 7-8) | 

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. | As described in the primary outcome. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Follow-up (weeks 11-12) |