Personalised Process-based Psychological Intervention for Paediatric Headache Cases: An Idiographic Ecological Momentary Study With Weekly Feedback Provision
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Perceived progress in a personally defined goal (Visual analogue scale, one item 0-100).
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged 12-
- •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.
排除标准
- •Aged younger than 12 or older than
- •Presence, history or suspicion of secondary headache disorder.
- •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)
- •Diagnosis of pervasive developmental disorder or serious mental health difficulty (e.g., psychosis, active suicidal thoughts) as determined by the referrer.
- •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.
研究组 & 干预措施
5 weekly online brief therapy sessions
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.
干预措施: PBT Personalised (Behavioral)
结局指标
主要结局
Perceived progress in a personally defined goal (Visual analogue scale, one item 0-100).
时间窗: From enrollment to the end of the 1 month follow-up
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.
Perceived ability to cope with headache (one visual analogue item - 0-100)
时间窗: From enrolment till the end of 1 month follow-up
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.
Perceived headache interference (one visual analogue item - 0-100)
时间窗: From enrolment till the end of 1 month follow-up
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.
Headache activity (2 items visual analogue scale- 0-100: headache frequency and intensity)
时间窗: From enrolment till the end of 1 month follow-up
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.
次要结局
- Paediatric Pain Interference (PPI)(From enrollment once per week till the end of 1 month follow-up)
- Paediatric Migraine Disability Assessment Scale (PedMIDAS)(From enrollment once per week till the end of 1 month follow-up)
研究者
Vasilis S. Vasiliou
Lecturer in Clinical Psychology, HCPC Registered Practitioner in Clinical & Health Psychology
Royal Holloway University