Migraine, Tension-Type Headache
Conditions
Brief 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.
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).
Interventions
BEHAVIORALHypnosis.
Online, group-based, single session hypnosis workshop followed by 2 weeks of self hypnosis.
OTHERUsual care
Participants will be asked to continue with whatever interventions they are already receiving/employing to manage their migraine and tension-type headaches.
Sponsors
Canterbury Christ Church University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline at 7-8 weeks in mean headache rating averaged over 2 weeks of headache diary entries. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline at week 11 on the Depression, Anxiety and Stress Scales - 21 item version (DASS-21) | Follow-up (week 11) | This measures symptoms of depression, anxiety and stress producing a score between 0 and 63, with higher scores indicating greater symptomatology. |
| Change from baseline at week 11 on the Headache Management Self-efficacy Scale (HMSE). | Follow-up (week 11) | 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. |
| Change from baseline at 7-8 weeks in headache related medication consumption over a two week period. | Post intervention (weeks 7-8) | 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. |
| Change from baseline at 11-12 weeks in headache related medication consumption over a two week period. | Follow-up (weeks 11-12) | 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. |
| Change from baseline at 11-12 weeks in mean headache rating averaged over 2 weeks of headache diary entries. | Follow-up (weeks 11-12) | As described in the primary outcome. |
| Change from baseline at 7-8 weeks in headache frequency over 2 weeks of headache diary entries. | Post intervention (weeks 7-8) | Using the aforementioned headache diary, the frequency of headaches over the 2 week diary period will be calculated. |
| Change from baseline at 11-12 weeks in headache frequency over 2 weeks of headache diary entries. | Follow-up (weeks 11-12) | Using the aforementioned headache diary, the frequency of headaches over the 2 week diary period will be calculated. |
| Change from baseline at 7-8 weeks in mean headache duration over 2 weeks of headache diary entries. | Post intervention (weeks 7-8) | Using the aforementioned headache diary, the mean duration of headaches over the 2 week diary period will be calculated. |
| Change from baseline at 11-12 weeks in mean headache duration over 2 weeks of headache diary entries. | Follow-up (weeks 11-12) | Using the aforementioned headache diary, the mean duration of headaches over the 2 week diary period will be calculated. |
| Change from baseline at week 7 on the Depression, Anxiety and Stress Scales - 21 item version (DASS-21) | Post intervention (week 7) | This measures symptoms of depression, anxiety and stress producing a score between 0 and 63, with higher scores indicating greater symptomatology. |
| Change from baseline at week 7 on the Warwick-Edinburgh Mental Wellbeing (WEMWBS) Scale | Post intervention (week 7) | This measures psychological wellbeing, producing a score between 15 and 75, with higher scores indicating greater wellbeing. |
| Change from baseline at week 11 on the Warwick-Edinburgh Mental Wellbeing (WEMWBS) Scale | Follow-up (week 11) | This measures psychological wellbeing, producing a score between 15 and 75, with higher scores indicating greater wellbeing. |
| Change from baseline at week 7 on the Headache-Specific Locus of Control Scale (HSLC). | Post intervention (week 7) | 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. |
| Change from baseline at week 11 on the Headache-Specific Locus of Control Scale (HSLC). | Follow-up (week 11) | 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. |
| Change from baseline at week 7 on the Headache Management Self-efficacy Scale (HMSE). | Post intervention (week 7) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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]. | Within the online, group-based intervention session (week 2). | 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. |
| Baseline scores on the Credibility/Expectancy of Change Questionnaire will moderate the primary and secondary outcomes. | Baseline (week 0) | 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. |
| Baseline scores on the Attitudes Towards Hypnosis scale will moderate the primary and secondary outcomes specified above. | Baseline (week 0) | 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. |
Countries
United Kingdom
Outcome results
None listed