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

Not Applicable

Completed

• Conditions: Migraine; Tension-Type Headache

• 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).

Study Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-21
• Study Start: 2020-10-27
• Primary Completion: 2021-02-24
• Study Completion: 2021-02-24
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 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 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 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