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Completed

NCT Number: NCT04523311

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Tension-Type Headache

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salomons Institute for Applied Psychology

Royal Tunbridge Wells, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypnosis.

Behavioral

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

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Canterbury Christ Church University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2020
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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