An interventional study of PBT Personalised in Primary Headaches (Includes Migraines, Tension, Cluster Headaches), sponsored by Royal Holloway University. Completed at 1 site in United Kingdom. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Royal Holloway University · Not applicable, Interventional, and Supportive care
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.
Paediatric primary headaches represent a highly common health condition, affecting more than 62% of children and adolescents globally. These headaches contribute substantially to difficulties in day-to-day functioning, including disruptions in academic engagement and participation in social or leisure activities. Adolescents also report reductions in overall quality of life associated with recurrent headaches.
Despite this significant burden, current psychological treatments demonstrate only small to medium effects in reducing headache-related impairment and improving quality of life. Progress in treatment efficacy has remained relatively limited. For example, although Cognitive Behavioural Therapy (CBT) is the recommended psychological approach for managing paediatric headaches, only around half of young people receiving CBT show meaningful improvements in disability and functional outcomes. This suggests that conventional delivery formats may not adequately address individual differences in needs and symptom patterns.
Personalised psychological interventions-those tailored to the specific goals, characteristics, and difficulties of each individual-offer a promising avenue for optimising treatment effectiveness in young people. Such approaches focus on personally meaningful targets and select therapeutic components that best support progress toward those targets. A recent systematic review aggregating data across multiple studies provides evidence that personalised interventions can enhance outcomes linked to personally defined goals. However, research examining personalised treatment approaches specifically within paediatric populations remains limited.
One emerging framework for delivering personalised care is Process-Based Therapy (PBT). PBT involves the ongoing identification and monitoring of the psychological, behavioural, and environmental processes that contribute to an adolescent's headaches-such as triggers, coping behaviours, contextual stressors, and emotional responses. This approach relies on regular, repeated data collection in adolescents' natural environments, which provides therapists with up-to-date information that can be used to guide treatment decisions. The 2012 NICE guidelines for headache management in individuals over 12 years old already recommend tracking headache severity, frequency, and duration with diaries, highlighting the value of continuous monitoring.
Within our study, this ongoing assessment-feedback loop enabled therapists to observe short-term changes, refine hypotheses about maintaining processes, and adjust intervention components accordingly (e.g., introducing emotional regulation strategies if data indicated high emotional reactivity during headache episodes).
PBT appears particularly suited to paediatric headache management, where adolescents often present with diverse symptom profiles and needs. Rather than constituting a new therapeutic model, PBT represents a shift in the delivery of therapy-emphasising the selection of targeted CBT-based strategies to influence key processes of change, rather than relying on standardised, protocol-driven, diagnosis-specific treatment packages.
A defining feature of PBT is the use of continuous data collection methods such as Ecological Momentary Assessment (EMA). EMA involves gathering brief, real-time information multiple times per week in adolescents' everyday environments, enabling accurate capture of their moment-to-moment experiences. In addition to providing rich data for clinical decision-making, EMA has been shown to enhance young people's insight, self-awareness, and ability to self-manage headache-related difficulties. In this study, EMA was used to collect weekly data, supporting both progress monitoring and the ongoing tailoring of interventions to each adolescent's specific needs.
123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.
This study's enrollment of 5 is below the median of 42 across 90 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →Royal Holloway University is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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No current or prior engagement with psychological support for headache for up to 6 months before screening.
Exclusion Criteria:
Each participant was invited to attend up to five weekly online brief therapy sessions, each lasting approximately 30-40 minutes. These sessions focused on the specific target processes identified during Phase 2. The personalised intervention drew on established, evidence-based CBT-informed approaches for managing headaches. Personalisation of the intervention was an ongoing collaborative process. The research team reviewed participants' collected data each week, and this information directly informed the focus of each subsequent session. The data collection schedule remained the same as in Phase 3: on three days per week, participants received 2-3 prompts to complete a brief questionnaire, and once per week they were asked to complete a measure assessing headache-related disability and interference. At the final session, participants completed a Client Feedback Form based on Sekhon et al.'s (2018) Theoretical Framework of Acceptability (TFA) for health 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.
Perceived progress in a personally defined goal (Visual analogue scale, one item 0-100).
This is one visual analogue scale as per ecological momentary assessment suggestions. A higher score in this item denotes higher perceived progress in personally defined goals.
Time frame: From enrollment to the end of the 1 month follow-up
Perceived ability to cope with headache (one visual analogue item - 0-100)
This is one visual analogue item as per the ecological momentary assessment suggestions. A higher score in this item denotes higher perceived ability to cope with headaches.
Time frame: From enrolment till the end of 1 month follow-up
Perceived headache interference (one visual analogue item - 0-100)
This is one visual analogue scale as per ecological momentary assessment suggestions. A higher score in this item indicates lower interference of headache in daily life activities.
Time frame: From enrolment till the end of 1 month follow-up
Headache activity (2 items visual analogue scale- 0-100: headache frequency and intensity)
We measured headache frequency and headache intensity every 3 days. For headache frequency, participants were asked to state the number of episodes they have had in a week (e.g."1 episode"). Headache intensity was measured on a visual analogue scale (VAS )from 0 to 100, where 0 represented "no headache" and 100 represented "extreme pain". This is a reliable and valid method to obtain a self-report measure of pain in paediatric samples (von Baeyer, 2009). A higher score in these two items indicates higher headache frequency and intensity, respectively.
Time frame: From enrolment till the end of 1 month follow-up
Paediatric Pain Interference (PPI)
The Patient Reported Outcomes Measurement Information System (PROMIS) Paediatric Pain Interference (PPI) 8 Item Bank measures the daily interference of pain on physical, psychological, and social functioning. Each item is scored on a 1-5 Likert scale ranging from "never" to "almost always", with min and max scores ranging from 8 to 40. Higher scores indicate greater pain interference. This is a unidimensional item bank which has been validated in paediatric chronic pain samples and has been shown to have good internal consistency (Cronbach's alpha= 0.9).
Time frame: From enrollment once per week till the end of 1 month follow-up
Paediatric Migraine Disability Assessment Scale (PedMIDAS)
The Paediatric Migraine Disability Assessment Scale (PedMIDAS) is a 6-item questionnaire measuring the frequency of disruption (using days as the unit) to daily activities caused by headache. The scores range from 0-240, where \>50 indicates severe impairment, 31-50 moderate, 11-30 is mild, and 0-10 is little to no impairment. The PedMIDAS has been shown to have internal consistency (Cronbach's alpha 0.80) and validity in measuring headache-related disability. While the PedMIDAS asks individuals to retrospectively estimate disruption to daily activities over a period of 3 months, we adapted the questionnaire to ask individuals to estimate disruption over a one-week period, to increase sensitivity to changes within shorter time periods.
Time frame: From enrollment once per week till the end of 1 month follow-up
Client Feedback Form
We administered a Client Feedback Form at the end of the follow-up period, based on Sekhon et al.'s theoretical framework of acceptability (TFA) for health interventions. This includes six items, rated on a 5-point Likert scale: affective attitude, burden, perceived effectiveness, intervention coherence, self-efficacy, and opportunity/ costs. Participants were provided with an optional qualitative comment box for further feedback.
Time frame: Once at the end of the follow-up period (1 month)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — A fully anonymised dataset may become available for further analyses.
Ran from Feb 2024 to primary completion in Mar 2025, 13 months.
Of 26 interventional studies with no phase under Cluster Headache, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 25. This study's 13 months is below that.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Royal Holloway University