Personalised Process-based Psychological Interventions for Paediatric Headaches

NCT07418723 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-08-18

No results posted yet for this study

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.

Conditions

  • Primary Headaches (Includes Migraines, Tension, Cluster Headaches)

Interventions

BEHAVIORAL

PBT Personalised

Participants took part in up to five online brief therapy sessions, each focusing on the key processes identified during their initial assessment and refined throughout treatment. The intervention drew on evidence-based CBT-informed strategies for headache management, and clinical supervision was provided by the lead project supervisor. Because the approach was highly individualised, no fixed protocol was followed. Consistent with Process-Based Therapy, each adolescent's network map was treated as a dynamic formulation and was updated regularly. Weekly EMA data were collected between sessions and reviewed with participants to refine the map and guide session priorities. This integration of EMA feedback and evolving case formulation enabled a personalised and flexible intervention, informing the specific processes targeted and decisions about the overall direction of therapy.

Sponsors & Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    collaborator OTHER
  • The Hillingdon Hospitals NHS Foundation Trust

    collaborator OTHER_GOV
  • UCLH

    collaborator UNKNOWN
  • Royal Holloway University

    lead OTHER

Principal Investigators

  • Jess Kingston, Ph.D. · Royal Holloway University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-09
Primary Completion
2025-03-28
Completion
2025-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07418723 on ClinicalTrials.gov