Can a digital self-help tool, created together with autistic people, support them in managing headaches?

Feasibility of a co-designed digital self-management intervention for autistic individuals with headache: a mixed methods study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12504081

Enrollment

Registered

2026-07-01

Start date

2026-09-01

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Self reported persistent or chronic headache in autistic individuals Nervous System Diseases

Interventions

This is a two-phase, single-arm mixed-methods feasibility study. There is no control group and no randomisation. Phase 1 (qualitative and co-design): participants take part in one semi-structured int

Eligibility

Sex/Gender

All

Age

16 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age 16 or older 2. Formal autism diagnosis or self-identification as autistic 3. Persistent primary headache disorder or cervicogenic headaches 4. Persistent defined as: 4.1. Episodic (1 to 14 days per month) 4.2. Chronic (15 or more days per month) headache for 3 months or more

Exclusion criteria

Exclusion criteria: 1. Currently enrolled in another headache or pain intervention trial 2. New headache, or symptoms suggestive of serious pathology (red flags, or secondary headaches other than cervicogenic) 3. Acute mental health (for example, very recent hospital admission or active care from a crisis team) 4. Photosensitive epilepsy, or epilepsy where the participant has been advised against the use of mobile screen-based apps

Design outcomes

Primary

Measure	Time frame
Recruitment over 6 month recruitment window measured using the number of participants enrolled as a proportion of the Phase 2 target of 20, collected at one time point at the end of the study;Retention measured using the proportion of enrolled participants completing the Week 10 outcome measures at Week 10;App engagement measured using the mean logins per week and proportion of available modules completed between Weeks 0 - 10, collected at one time point at the end of the study;Outcome-measure completeness measured using data on the item-level completeness of the Headache Impact Test (HIT-6) questionnaire, Generalized Anxiety Disorder 7-item (GAD-7) and the System Usability Scale (SUS) between Week 0 and Week 10, collected at one time point at the end of the study	—

Measure

Time frame

Recruitment over 6 month recruitment window measured using the number of participants enrolled as a proportion of the Phase 2 target of 20, collected at one time point at the end of the study;Retention measured using the proportion of enrolled participants completing the Week 10 outcome measures at Week 10;App engagement measured using the mean logins per week and proportion of available modules completed between Weeks 0 - 10, collected at one time point at the end of the study;Outcome-measure completeness measured using data on the item-level completeness of the Headache Impact Test (HIT-6) questionnaire, Generalized Anxiety Disorder 7-item (GAD-7) and the System Usability Scale (SUS) between Week 0 and Week 10, collected at one time point at the end of the study

—

Countries

England, Ireland, Isle of Man, Northern Ireland, Scotland, United Kingdom, Wales

Contacts

Public ContactJoanne Marley

j.marley@ulster.ac.uk+44 07515680571

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026