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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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.
Salomons Institute for Applied Psychology
Royal Tunbridge Wells, United Kingdom
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.
Time frame: Post intervention (weeks 7-8)
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.
Time frame: 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.
Time frame: 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.
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.
Using the aforementioned headache diary, the mean duration of headaches over the 2 week diary period will be calculated.
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.
Using the aforementioned headache diary, the mean duration of headaches over the 2 week diary period will be calculated.
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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)
This measures symptoms of depression, anxiety and stress producing a score between 0 and 63, with higher scores indicating greater symptomatology.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Follow-up (weeks 11-12)