Clinical trial NCT04523311: 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
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Tension-Type Headache
Lead sponsor: Canterbury Christ Church University
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change from baseline at 7-8 weeks in mean headache rating averaged over 2 weeks of headache diary entries.
timeFrame: Post intervention (weeks 7-8)
Secondary outcomes:
measure: Change from baseline at 11-12 weeks in mean headache rating averaged over 2 weeks of headache diary entries.
timeFrame: Follow-up (weeks 11-12)
measure: Change from baseline at 7-8 weeks in headache frequency over 2 weeks of headache diary entries.
timeFrame: Post intervention (weeks 7-8)
measure: Change from baseline at 11-12 weeks in headache frequency over 2 weeks of headache diary entries.
timeFrame: Follow-up (weeks 11-12)
measure: Change from baseline at 7-8 weeks in mean headache duration over 2 weeks of headache diary entries.
timeFrame: Post intervention (weeks 7-8)
measure: Change from baseline at 11-12 weeks in mean headache duration over 2 weeks of headache diary entries.
timeFrame: Follow-up (weeks 11-12)
measure: Change from baseline at week 7 on the Depression, Anxiety and Stress Scales - 21 item version (DASS-21)
timeFrame: Post intervention (week 7)
measure: Change from baseline at week 11 on the Depression, Anxiety and Stress Scales - 21 item version (DASS-21)
timeFrame: Follow-up (week 11)
measure: Change from baseline at week 7 on the Warwick-Edinburgh Mental Wellbeing (WEMWBS) Scale
timeFrame: Post intervention (week 7)
measure: Change from baseline at week 11 on the Warwick-Edinburgh Mental Wellbeing (WEMWBS) Scale
timeFrame: Follow-up (week 11)
measure: Change from baseline at week 7 on the Headache-Specific Locus of Control Scale (HSLC).
timeFrame: Post intervention (week 7)
measure: Change from baseline at week 11 on the Headache-Specific Locus of Control Scale (HSLC).
timeFrame: Follow-up (week 11)
measure: Change from baseline at week 7 on the Headache Management Self-efficacy Scale (HMSE).
timeFrame: Post intervention (week 7)
measure: Change from baseline at week 11 on the Headache Management Self-efficacy Scale (HMSE).
timeFrame: Follow-up (week 11)
measure: Change from baseline at 7-8 weeks in headache related medication consumption over a two week period.
timeFrame: Post intervention (weeks 7-8)
measure: Change from baseline at 11-12 weeks in headache related medication consumption over a two week period.
timeFrame: Follow-up (weeks 11-12)
Other outcomes:
measure: Baseline scores on the Credibility/Expectancy of Change Questionnaire will moderate the primary and secondary outcomes.
timeFrame: Baseline (week 0)
measure: Baseline scores on the Attitudes Towards Hypnosis scale will moderate the primary and secondary outcomes specified above.
timeFrame: Baseline (week 0)
measure: 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].
timeFrame: Within the online, group-based intervention session (week 2).
Locations:
city: Tunbridge Wells
country: United Kingdom
facility: Salomons Institute for Applied Psychology
Study officials:
affiliation: Canterbury Christ Church University
name: Paul Davies, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Canterbury Christ Church University
name: Fergal Jones, PhD, PsychD
role: STUDY_DIRECTOR
affiliation: Private Practice
name: Robert Agnew, DClinPsych
role: STUDY_DIRECTOR
References: