An Evaluation of Brief Online Hypnosis for Migraine and Tension-type Headaches
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change from baseline at 7-8 weeks in mean headache rating averaged over 2 weeks of headache diary entries.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Hypnosis. (Behavioral)
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.
干预措施: Usual care (Other)
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.
干预措施: Usual care (Other)
结局指标
主要结局
Change from baseline at 7-8 weeks in mean headache rating averaged over 2 weeks of headache diary entries.
时间窗: 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.
次要结局
- Change from baseline at 11-12 weeks in mean headache duration over 2 weeks of headache diary entries.(Follow-up (weeks 11-12))
- Change from baseline at week 7 on the Warwick-Edinburgh Mental Wellbeing (WEMWBS) Scale(Post intervention (week 7))
- 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 week 7 on the Depression, Anxiety and Stress Scales - 21 item version (DASS-21)(Post intervention (week 7))
- Change from baseline at week 11 on the Warwick-Edinburgh Mental Wellbeing (WEMWBS) Scale(Follow-up (week 11))
- Change from baseline at week 7 on the Headache-Specific Locus of Control Scale (HSLC).(Post intervention (week 7))
- Change from baseline at week 7 on the Headache Management Self-efficacy Scale (HMSE).(Post intervention (week 7))
- 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 7-8 weeks in mean headache duration over 2 weeks of headache diary entries.(Post intervention (weeks 7-8))
- Change from baseline at week 11 on the Depression, Anxiety and Stress Scales - 21 item version (DASS-21)(Follow-up (week 11))
- Change from baseline at week 11 on the Headache-Specific Locus of Control Scale (HSLC).(Follow-up (week 11))
- Change from baseline at 11-12 weeks in headache related medication consumption over a two week period.(Follow-up (weeks 11-12))
- Change from baseline at week 11 on the Headache Management Self-efficacy Scale (HMSE).(Follow-up (week 11))
- Change from baseline at 7-8 weeks in headache related medication consumption over a two week period.(Post intervention (weeks 7-8))