Personalised Process-based Psychological Interventions for Paediatric Headaches

NCT07418723 | Completed

• 1 other identifier: 24/SS/0077 (IRAS:340890)
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

headaches; pediatric headaches; SCED; Disability; personalised therapy; process-based therapy; EMA

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  From enrolment till the end of 1 month follow-up

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Client Feedback Form

  Once at the end of the follow-up period (1 month)

Study Arms (1)

5 weekly online brief therapy sessions

EXPERIMENTAL

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

Interventions

PBT Personalised BEHAVIORAL

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.

5 weekly online brief therapy sessions

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Aged younger than 12 or older than 18.
• 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.

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator
• The Hillingdon Hospitals NHS Foundation Trust: collaborator
• Royal Holloway University: lead
• UCLH: collaborator

Study Sites (1)

Department of Psychology, Clinical psychology program, Bowyer Building

Egham, TW20 0EX, United Kingdom

Location

Related Publications (19)

• Tate, R. L., Perdices, M., Rosenkoetter, U., Shadish, W., Vohra, S., Barlow, D. H., Horner, R., Kazdin, A., Kratochwill, T., McDonald, S., Sampson, M., Shamseer, L., Togher, L., Albin, R., Backman, C., Douglas, J., Evans, J. J., Gast, D., Manolov, R., Mitchell, G., … Wilson, B. (2016). The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement. Physical therapy, 96(7), e1-e10. https://doi.org/10.2522/ptj.2016.96.7.e1

  BACKGROUND

• Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.

  PMID: 28126032 BACKGROUND

• Onofri, A., Pensato, U., Rosignoli, C., Wells-Gatnik, W., Stanyer, E., Ornello, R., Chen, H. Z., De Santis, F., Torrente, A., Mikulenka, P., Monte, G., Marschollek, K., Waliszewska-Prosół, M., Wiels, W., Boucherie, D. M., Onan, D., Farham, F., Al-Hassany, L., Sacco, S., & European Headache Federation School of Advanced Studies (EHF-SAS) (2023). Primary headache epidemiology in children and adolescents: a systematic review and meta-analysis. The journal of headache and pain, 24(1), 8. https://doi.org/10.1186/s10194-023-01541-0

  BACKGROUND

• Nye, A., Delgadillo, J., & Barkham, M. (2023). Efficacy of personalized psychological interventions: A systematic review and meta-analysis. Journal of consulting and clinical psychology, 91(7), 389-397. https://doi.org/10.1037/ccp0000820

  BACKGROUND

• Moskowitz, D. S., & Young, S. N. (2006). Ecological momentary assessment: what it is and why it is a method of the future in clinical psychopharmacology. Journal of psychiatry & neuroscience : JPN, 31(1), 13-20.

  BACKGROUND

• Mihura, J. L., Meyer, G. J., Dumitrascu, N., & Bombel, G. (2013). The validity of individual Rorschach variables: systematic reviews and meta-analyses of the comprehensive system. Psychological bulletin, 139(3), 548-605. https://doi.org/10.1037/a0029406

  BACKGROUND

• Law, E. F., Beals-Erickson, S. E., Noel, M., Claar, R., & Palermo, T. M. (2015). Pilot Randomized Controlled Trial of Internet-Delivered Cognitive-Behavioral Treatment for Pediatric Headache. Headache, 55(10), 1410-1425. https://doi.org/10.1111/head.12635

  BACKGROUND

• Larsson, B., Sigurdson, J. F., & Sund, A. M. (2018). Long-term follow-up of a community sample of adolescents with frequent headaches. The journal of headache and pain, 19(1), 79. https://doi.org/10.1186/s10194-018-0908-5

  BACKGROUND

• Kratochwill, T. R., Hitchcock, J. H., Horner, R. H., Levin, J. R., Odom, S. L., Rindskopf, D. M., & Shadish, W. R. (2013). Single-case intervention research design standards. Remedial and Special Education, 34(1), 26-38. https://doi.org/10.1177/0741932512452794

  BACKGROUND

• Krasny-Pacini, A., & Evans, J. (2018). Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Annals of physical and rehabilitation medicine, 61(3), 164-179. https://doi.org/10.1016/j.rehab.2017.12.002

  BACKGROUND

• Kazdin AE. Single-case experimental designs. Evaluating interventions in research and clinical practice. Behav Res Ther. 2019 Jun;117:3-17. doi: 10.1016/j.brat.2018.11.015. Epub 2018 Dec 2.

  PMID: 30527785 BACKGROUND

• Hershey, A. D., Powers, S. W., Vockell, A. L., LeCates, S., Kabbouche, M. A., & Maynard, M. K. (2001). PedMIDAS: development of a questionnaire to assess disability of migraines in children. Neurology, 57(11), 2034-2039. https://doi.org/10.1212/wnl.57.11.2034

  BACKGROUND

• Harnas, S. J., Knoop, H., Sprangers, M. A. G., & Braamse, A. M. J. (2024). Defining and operationalizing personalized psychological treatment - a systematic literature review. Cognitive Behaviour Therapy, 53(5), 467-489. https://doi.org/10.1080/16506073.2024.2333345

  BACKGROUND

• Gibler, R. C., Knestrick, K. E., Reidy, B. L., Lax, D. N., & Powers, S. W. (2022). Management of Chronic Migraine in Children and Adolescents: Where are We in 2022?. Pediatric health, medicine and therapeutics, 13, 309-323. https://doi.org/10.2147/PHMT.S334744

  BACKGROUND

• Cramm, J. M., Strating, M. M., Roebroeck, M. E., & Nieboer, A. P. (2013). The Importance of General Self-Efficacy for the Quality of Life of Adolescents with Chronic Conditions. Social indicators research, 113(1), 551-561. https://doi.org/10.1007/s11205-012-0110-0

  BACKGROUND

• Ceniza-Bordallo, G., Fraile, A. G., Martín-Casas, P., & López-de-Uralde-Villanueva, I. (2022). Validity and reliability of Spanish PROMIS pediatric pain interference short form. Journal of pediatric nursing, 66, 79-85. https://doi.org/10.1016/j.pedn.2022.05.015

  BACKGROUND

• Ciarrochi, J., Hayes, S. C., Oades, L. G., & Hofmann, S. G. (2022). Toward a Unified Framework for Positive Psychology Interventions: Evidence-Based Processes of Change in Coaching, Prevention, and Training. Frontiers in psychology, 12, 809362. https://doi.org/10.3389/fpsyg.2021.809362

  BACKGROUND

• Buhrman, M., Syk, M., Burvall, O., Hartig, T., Gordh, T., & Andersson, G. (2015). Individualized Guided Internet-delivered Cognitive-Behavior Therapy for Chronic Pain Patients With Comorbid Depression and Anxiety: A Randomized Controlled Trial. The Clinical journal of pain, 31(6), 504-516. https://doi.org/10.1097/AJP.0000000000000176

  BACKGROUND

• Bellini, B., Arruda, M., Cescut, A., Saulle, C., Persico, A., Carotenuto, M., Gatta, M., Nacinovich, R., Piazza, F. P., Termine, C., Tozzi, E., Lucchese, F., & Guidetti, V. (2013). Headache and comorbidity in children and adolescents. The journal of headache and pain, 14(1), 79. https://doi.org/10.1186/1129-2377-14-79

  BACKGROUND

Related Links

• The University's Doctoral repository, Calladine, A. (2025). Personalised process-based psychological interventions for paediatric headaches: a single-case experimental design study. \[Doctoral Thesis, Royal Holloway, University of London\].

MeSH Terms

Conditions

Cluster Headache; Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jess Kingston, Ph.D.

  Royal Holloway University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Clinical Psychology, HCPC Registered Practitioner in Clinical & Health Psychology

Model Details: This study employed a single-case experimental design (SCED) incorporating a combined multiple-baseline structure and Ecological Momentary Assessment (EMA) methodology. Each participant completed a baseline monitoring phase lasting between one and three weeks prior to receiving the intervention. During the study period, participants were asked not to begin any other psychological treatment for headaches to avoid confounding effects.

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 18, 2026
• Study Start: February 9, 2024
• Primary Completion: March 28, 2025
• Study Completion: April 30, 2025
• Last Updated: February 18, 2026

Record last verified: 2024-02

Locations

GB (1)