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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnosis. | Behavioral | Online, group-based, single session hypnosis workshop followed by 2 weeks of self hypnosis. |
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| 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) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline scores on the Credibility/Expectancy of Change Questionnaire will moderate the primary and secondary outcomes. | 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 (week 0) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Davies, MSc | Canterbury Christ Church University | Principal Investigator |
| Fergal Jones, PhD, PsychD | Canterbury Christ Church University | Study Director |
| Robert Agnew, DClinPsych | Private Practice | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salomons Institute for Applied Psychology | Royal Tunbridge Wells | United Kingdom |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D018781 | Tension-Type Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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| Usual care | Other | Participants will be asked to continue with whatever interventions they are already receiving/employing to manage their migraine and tension-type headaches. |
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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) |
| Baseline scores on the Attitudes Towards Hypnosis scale will moderate the primary and secondary outcomes specified above. | 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. | Baseline (week 0) |
| 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]. | 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. | Within the online, group-based intervention session (week 2). |
| D009422 | Nervous System Diseases |
| D004191 |
| Behavioral Disciplines and Activities |