An Evaluation of Brief Online Hypnosis for Migraine and Tension-type Headaches
- Conditions
- MigraineTension-Type Headache
- Interventions
- Behavioral: Hypnosis.Other: Usual care
- Registration Number
- NCT04523311
- Lead Sponsor
- Canterbury Christ Church University
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hypnosis + usual care Hypnosis. 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. Waitlist control + usual care 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. Hypnosis + usual care 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 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 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 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.
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 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-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 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 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.
Trial Locations
- Locations (1)
Salomons Institute for Applied Psychology
🇬🇧Tunbridge Wells, United Kingdom