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

• ClinicalTrials.gov Identifier: NCT04523311
• Recruitment Status: Completed
• First Posted: August 21, 2020
• Last Update Posted: July 27, 2021
• Sponsor: Canterbury Christ Church University
• Information provided by (Responsible Party): Canterbury Christ Church University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Migraine; Tension-Type Headache	Behavioral: Hypnosis.; Other: Usual care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Evaluation of Brief Online Hypnosis for Migraine and Tension-type Headaches
• Actual Study Start Date: October 27, 2020
• Actual Primary Completion Date: February 24, 2021
• Actual Study Completion Date: February 24, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Hypnosis + 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.	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.
Waitlist control + 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Change from baseline at 7-8 weeks in mean headache rating averaged over 2 weeks of headache diary entries. [ Time Frame: 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 :

1. Change from baseline at 11-12 weeks in mean headache rating averaged over 2 weeks of headache diary entries. [ Time Frame: Follow-up (weeks 11-12) ]
   As described in the primary outcome.
2. Change from baseline at 7-8 weeks in headache frequency over 2 weeks of headache diary entries. [ Time Frame: Post intervention (weeks 7-8) ]
   Using the aforementioned headache diary, the frequency of headaches over the 2 week diary period will be calculated.
3. Change from baseline at 11-12 weeks in headache frequency over 2 weeks of headache diary entries. [ Time Frame: Follow-up (weeks 11-12) ]
   Using the aforementioned headache diary, the frequency of headaches over the 2 week diary period will be calculated.
4. Change from baseline at 7-8 weeks in mean headache duration over 2 weeks of headache diary entries. [ Time Frame: Post intervention (weeks 7-8) ]
   Using the aforementioned headache diary, the mean duration of headaches over the 2 week diary period will be calculated.
5. Change from baseline at 11-12 weeks in mean headache duration over 2 weeks of headache diary entries. [ Time Frame: Follow-up (weeks 11-12) ]
   Using the aforementioned headache diary, the mean duration of headaches over the 2 week diary period will be calculated.
6. Change from baseline at week 7 on the Depression, Anxiety and Stress Scales - 21 item version (DASS-21) [ Time Frame: 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.
7. Change from baseline at week 11 on the Depression, Anxiety and Stress Scales - 21 item version (DASS-21) [ Time Frame: 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.
8. Change from baseline at week 7 on the Warwick-Edinburgh Mental Wellbeing (WEMWBS) Scale [ Time Frame: Post intervention (week 7) ]
   This measures psychological wellbeing, producing a score between 15 and 75, with higher scores indicating greater wellbeing.
9. Change from baseline at week 11 on the Warwick-Edinburgh Mental Wellbeing (WEMWBS) Scale [ Time Frame: Follow-up (week 11) ]
   This measures psychological wellbeing, producing a score between 15 and 75, with higher scores indicating greater wellbeing.
10. Change from baseline at week 7 on the Headache-Specific Locus of Control Scale (HSLC). [ Time Frame: 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.
11. Change from baseline at week 11 on the Headache-Specific Locus of Control Scale (HSLC). [ Time Frame: 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.
12. Change from baseline at week 7 on the Headache Management Self-efficacy Scale (HMSE). [ Time Frame: 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.
13. Change from baseline at week 11 on the Headache Management Self-efficacy Scale (HMSE). [ Time Frame: 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.
14. Change from baseline at 7-8 weeks in headache related medication consumption over a two week period. [ Time Frame: 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.
15. Change from baseline at 11-12 weeks in headache related medication consumption over a two week period. [ Time Frame: 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.

Other Outcome Measures:

1. Baseline scores on the Credibility/Expectancy of Change Questionnaire will moderate the primary and secondary outcomes. [ Time Frame: Baseline (week 0) ]
   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.
2. Baseline scores on the Attitudes Towards Hypnosis scale will moderate the primary and secondary outcomes specified above. [ Time Frame: Baseline (week 0) ]
   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.
3. 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]. [ Time Frame: Within the online, group-based intervention session (week 2). ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United Kingdom

Salomons Institute for Applied Psychology

Tunbridge Wells, United Kingdom

Sponsors and Collaborators

Canterbury Christ Church University

Investigators

• Principal Investigator: Paul Davies, MSc; Canterbury Christ Church University
• Study Director: Fergal Jones, PhD, PsychD; Canterbury Christ Church University
• Study Director: Robert Agnew, DClinPsych; Private Practice

More Information

• Responsible Party: Canterbury Christ Church University
• ClinicalTrials.gov Identifier: NCT04523311
• Other Study ID Numbers: PaulDavies2020
• First Posted: August 21, 2020
• Last Update Posted: July 27, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Migraine Disorders; Tension-Type Headache; Headache; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations