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

Primary Purpose

Migraine, Tension-Type Headache

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hypnosis.
Usual care
Sponsored by
Canterbury Christ Church University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Salomons Institute for Applied Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Hypnosis + usual care

Waitlist control + usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 19, 2020
Last Updated
July 26, 2021
Sponsor
Canterbury Christ Church University
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1. Study Identification

Unique Protocol Identification Number
NCT04523311
Brief Title
An Evaluation of Brief Online Hypnosis for Migraine and Tension-type Headaches
Official Title
An Evaluation of Brief Online Hypnosis for Migraine and Tension-type Headaches
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
February 24, 2021 (Actual)
Study Completion Date
February 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canterbury Christ Church University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Tension-Type Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis + usual care
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control + usual care
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis.
Intervention Description
Online, group-based, single session hypnosis workshop followed by 2 weeks of self hypnosis.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Participants will be asked to continue with whatever interventions they are already receiving/employing to manage their migraine and tension-type headaches.
Primary Outcome Measure Information:
Title
Change from baseline at 7-8 weeks in mean headache rating averaged over 2 weeks of headache diary entries.
Description
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.
Time Frame
Post intervention (weeks 7-8)
Secondary Outcome Measure Information:
Title
Change from baseline at 11-12 weeks in mean headache rating averaged over 2 weeks of headache diary entries.
Description
As described in the primary outcome.
Time Frame
Follow-up (weeks 11-12)
Title
Change from baseline at 7-8 weeks in headache frequency over 2 weeks of headache diary entries.
Description
Using the aforementioned headache diary, the frequency of headaches over the 2 week diary period will be calculated.
Time Frame
Post intervention (weeks 7-8)
Title
Change from baseline at 11-12 weeks in headache frequency over 2 weeks of headache diary entries.
Description
Using the aforementioned headache diary, the frequency of headaches over the 2 week diary period will be calculated.
Time Frame
Follow-up (weeks 11-12)
Title
Change from baseline at 7-8 weeks in mean headache duration over 2 weeks of headache diary entries.
Description
Using the aforementioned headache diary, the mean duration of headaches over the 2 week diary period will be calculated.
Time Frame
Post intervention (weeks 7-8)
Title
Change from baseline at 11-12 weeks in mean headache duration over 2 weeks of headache diary entries.
Description
Using the aforementioned headache diary, the mean duration of headaches over the 2 week diary period will be calculated.
Time Frame
Follow-up (weeks 11-12)
Title
Change from baseline at week 7 on the Depression, Anxiety and Stress Scales - 21 item version (DASS-21)
Description
This measures symptoms of depression, anxiety and stress producing a score between 0 and 63, with higher scores indicating greater symptomatology.
Time Frame
Post intervention (week 7)
Title
Change from baseline at week 11 on the Depression, Anxiety and Stress Scales - 21 item version (DASS-21)
Description
This measures symptoms of depression, anxiety and stress producing a score between 0 and 63, with higher scores indicating greater symptomatology.
Time Frame
Follow-up (week 11)
Title
Change from baseline at week 7 on the Warwick-Edinburgh Mental Wellbeing (WEMWBS) Scale
Description
This measures psychological wellbeing, producing a score between 15 and 75, with higher scores indicating greater wellbeing.
Time Frame
Post intervention (week 7)
Title
Change from baseline at week 11 on the Warwick-Edinburgh Mental Wellbeing (WEMWBS) Scale
Description
This measures psychological wellbeing, producing a score between 15 and 75, with higher scores indicating greater wellbeing.
Time Frame
Follow-up (week 11)
Title
Change from baseline at week 7 on the Headache-Specific Locus of Control Scale (HSLC).
Description
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.
Time Frame
Post intervention (week 7)
Title
Change from baseline at week 11 on the Headache-Specific Locus of Control Scale (HSLC).
Description
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.
Time Frame
Follow-up (week 11)
Title
Change from baseline at week 7 on the Headache Management Self-efficacy Scale (HMSE).
Description
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.
Time Frame
Post intervention (week 7)
Title
Change from baseline at week 11 on the Headache Management Self-efficacy Scale (HMSE).
Description
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.
Time Frame
Follow-up (week 11)
Title
Change from baseline at 7-8 weeks in headache related medication consumption over a two week period.
Description
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.
Time Frame
Post intervention (weeks 7-8)
Title
Change from baseline at 11-12 weeks in headache related medication consumption over a two week period.
Description
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.
Time Frame
Follow-up (weeks 11-12)
Other Pre-specified Outcome Measures:
Title
Baseline scores on the Credibility/Expectancy of Change Questionnaire will moderate the primary and secondary outcomes.
Description
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.
Time Frame
Baseline (week 0)
Title
Baseline scores on the Attitudes Towards Hypnosis scale will moderate the primary and secondary outcomes specified above.
Description
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.
Time Frame
Baseline (week 0)
Title
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].
Description
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.
Time Frame
Within the online, group-based intervention session (week 2).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Davies, MSc
Organizational Affiliation
Canterbury Christ Church University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fergal Jones, PhD, PsychD
Organizational Affiliation
Canterbury Christ Church University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robert Agnew, DClinPsych
Organizational Affiliation
Private Practice
Official's Role
Study Director
Facility Information:
Facility Name
Salomons Institute for Applied Psychology
City
Tunbridge Wells
Country
United Kingdom

12. IPD Sharing Statement

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

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