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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04523311
• Other study ID #: PaulDavies2020
• Status: Completed
• Phase: N/A
• Start date: October 27, 2020
• Est. completion date: February 24, 2021

Study information

• Verified date: July 2021
• Source: Canterbury Christ Church University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 24, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders
• Tension-Type Headache

Intervention

Behavioral:
• Hypnosis.
Online, group-based, single session hypnosis workshop followed by 2 weeks of self hypnosis.

Other:
• Usual care
Participants will be asked to continue with whatever interventions they are already receiving/employing to manage their migraine and tension-type headaches.

Locations

Country	Name	City	State
United Kingdom	Salomons Institute for Applied Psychology	Tunbridge Wells

Sponsors (1)

Lead Sponsor	Collaborator
Canterbury Christ Church University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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).
Primary	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)
Secondary	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)
Secondary	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.	Post intervention (weeks 7-8)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)