Clinical Trial

Personalised Process-based Psychological Interventions for Paediatric Headaches

Study acronym: HEAD-FLEX
Completed
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Summary
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.
Trial Details
NCT Number NCT07418723
Lead Sponsor Royal Holloway University
Collaborators: Great Ormond Street Hospital for Children NHS Foundation Trust, The Hillingdon Hospitals NHS Foundation Trust, UCLH
Conditions Primary Headaches (Includes Migraines, Tension, Cluster Headaches)
Enrollment 5 participants
Start Date 2024-02-09
Primary Completion 2025-03-28 (estimated)
Study Completion 2025-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-18