An Evaluation of Brief Online Hypnosis for Migraine and Tension-type Headaches
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2020
CompletedFirst Posted
Study publicly available on registry
August 21, 2020
CompletedStudy Start
First participant enrolled
October 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2021
CompletedJuly 27, 2021
July 1, 2021
4 months
August 19, 2020
July 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (15)
Change from baseline at 11-12 weeks in mean headache rating averaged over 2 weeks of headache diary entries.
Follow-up (weeks 11-12)
Change from baseline at 7-8 weeks in headache frequency over 2 weeks of headache diary entries.
Post intervention (weeks 7-8)
Change from baseline at 11-12 weeks in headache frequency over 2 weeks of headache diary entries.
Follow-up (weeks 11-12)
Change from baseline at 7-8 weeks in mean headache duration over 2 weeks of headache diary entries.
Post intervention (weeks 7-8)
Change from baseline at 11-12 weeks in mean headache duration over 2 weeks of headache diary entries.
Follow-up (weeks 11-12)
- +10 more secondary outcomes
Other Outcomes (3)
Baseline scores on the Credibility/Expectancy of Change Questionnaire will moderate the primary and secondary outcomes.
Baseline (week 0)
Baseline scores on the Attitudes Towards Hypnosis scale will moderate the primary and secondary outcomes specified above.
Baseline (week 0)
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].
Within the online, group-based intervention session (week 2).
Study Arms (2)
Hypnosis + usual care
EXPERIMENTALAn online, group-based, single session hypnosis workshop followed by 2 weeks of self hypnosis. Participants will continue with whatever usual care they receive/undertake.
Waitlist control + usual care
OTHERThe 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.
Interventions
Online, group-based, single session hypnosis workshop followed by 2 weeks of self hypnosis.
Participants will be asked to continue with whatever interventions they are already receiving/employing to manage their migraine and tension-type headaches.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Salomons Institute for Applied Psychology
Royal Tunbridge Wells, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2020
First Posted
August 21, 2020
Study Start
October 27, 2020
Primary Completion
February 24, 2021
Study Completion
February 24, 2021
Last Updated
July 27, 2021
Record last verified: 2021-07