NCT07418723Completed
Personalised Process-based Psychological Interventions for Paediatric Headaches
Personalised Process-based Psychological Intervention for Paediatric Headache Cases: An Idiographic Ecological Momentary Study With Weekly Feedback Provision
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
This project was an empirical single-case experimental design (SCED) study conducted as part of a DClinPsy doctoral thesis completed by one of the researchers. The study used a brief and highly personalised psychological intervention for adolescents experiencing headaches. The aim was to understand how participants' real-time data could guide the personalised intervention provided to adolescents, including the development of skills to cope with headaches. The study began with an initial assessment of adolescents' (n = 6-8) headache experiences. Following this, the researchers formulated an individualised diagram for each participant to identify central problem areas or problematic responses relevant to their headaches. Based on these formulations, the team delivered a brief personalised intervention focused on developing adaptive psychological skills and coping responses. The intervention consisted of 4-5 weekly, 30-minute, one-to-one online sessions, targeting headache-related areas of concern. These sessions drew from established Cognitive Behavioural Therapy (CBT) and Acceptance and Commitment Therapy (ACT) interventions, both of which have previously been shown to reduce headache-related disability and improve functioning. During data collection, adolescents were prompted to complete brief online questionnaires on their smartphones. The questionnaires were personalised to each participant and measured specific psychological processes that had been identified as target areas during the assessment and formulation stages. This personalised data collection approach was then used to analyse individual-level changes and to explore how these changes facilitated progress in areas identified as important to each adolescent (e.g., school involvement or extracurricular activities). The study also examined whether overall headache-related disability decreased and whether daily functioning improved following the completion of the intervention.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 30 Jan 2026
- Start date
- 9 Feb 2024
- Primary completion date
- 28 Mar 2025
- Lead sponsor
- Royal Holloway University
- Diseases
- Migraine
- NCT number
- NCT07418723
What you commit to
- Study type: Interventional
- Participants enrolled: 5
- From 9 Feb 2024 to the primary completion date, 28 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving psychological support for headaches or having prior engagement with psychological support for headaches up to 6 months before screening.
- An indication of a need for multisystemic therapies (e.g. a PedMIDAS score of 140)
Other illness
- Presence, history or suspicion of secondary headache disorder.
- Diagnosis of pervasive developmental disorder or serious mental health difficulty (e.g., psychosis, active suicidal thoughts) as determined by the referrer.
Age
- Aged younger than 12 or older than 18.
Other
- Adolescents living in families experiencing significant distress or psychosocial issues.
- Adolescents and their carer not fluent in speaking and writing in English.
- Limited access to a smartphone device with a consistent internet connection.
Who the study is looking for
- Adolescents aged 12-18.
- Recurrent headaches occurring for 3 months or more, ideally (but not necessarily) diagnosed as a primary headache by a Neurologist.
- The headache should be deemed to be resulting from a primary headache disorder as opposed to a secondary symptom of another health condition.
- No current or prior engagement with psychological support for headache for up to 6 months before screening.
- Experiencing at least minimal disability or interference from headaches (e.g. PedMIDAS score of greater than 10 points
- Adolescents and their caregiver fluent in speaking and writing in English.
- Frequent access to a smartphone with consistent internet access.
Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Psychology, Clinical psychology program, Bowyer Building Coordinator of this site? Confirm its status | Egham | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.