NCT07265362

Brief Summary

It has frequently been shown that people with long term physical health conditions, like epilepsy, are more likely to have mental health conditions. Studies have shown people with epilepsy report high levels of shame, stress, social isolation and anxiety. Mental health interventions for people with epilepsy, particularly children, has been identified as an area for further research by the NHS. Compassion based interventions have been effective with people with long term physical health conditions. These interventions aim to develop an individual's compassion towards the self and others in response to self-criticism or shame. This study aims to explore whether Compassion Focussed Therapy informed psychoeducation and Loving Kindness Meditation is a feasible and effective intervention for children with epilepsy. Children and young people aged 12-17 years old who have a diagnosis of epilepsy and mild/moderate distress related to their health condition are eligible. Local clinicians in epilepsy services will be asked to identify potential participants. Up to six children/young people will be included in the study. Participants will complete outcomes measures (about their quality of life, mood and self-compassion) weekly before the intervention, for up to five weeks, and then weekly until the end of the intervention. The intervention will be three sessions with the lead researcher, conducted online via Microsoft teams. Participants will then have four weeks to practice Loving Kindness Meditation. They will then have a follow up session about how they found the intervention, what was helpful and what they would change. The results from the study will indicate whether Compassion Focussed Therapy and Loving Kindness Meditation is a beneficial therapeutic intervention for children with epilepsy and if further research in the area is warranted.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Jan 2026Sep 2026

First Submitted

Initial submission to the registry

July 24, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

December 4, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

July 24, 2025

Last Update Submit

December 2, 2025

Conditions

Keywords

EpilepsyCompassion Focussed TherapyChildrenYoung PeopleTeenagersMental healthShameSelf-compassionLoving Kindness Meditation

Outcome Measures

Primary Outcomes (1)

  • Idiographic shame and self-compassion measures

    Idiographic shame and self-compassion weekly measures. Idiographic measures can be designed to ensure the relevant construct is measured by individual participants (Haynes et al., 2009). In this study, utilising idiographic measures will ensure we measure the constructs of shame and self-compassion more effectively than broader psychometric measures. Possible example shame question: "I have been bothered by other people's reactions to my seizures." Possible example self-compassion question: "I have been kind to myself when something has gone wrong."

    Weekly from baseline to end of intervnetion (13 to 15 weeks depending on randomly allocated baseline length)

Secondary Outcomes (3)

  • Glasgow Epilepsy Outcome Scale for Young Persons (GEOS-YP)

    At initial baseline, first week pre-intervention and in the final week after intervention has been complete - week 13, 14 or 15 depending on length of baseline.

  • PedsQL - parent/caregiver proxy report

    At initial baseline, first week pre-intervention and in the final week after intervention has been complete - week 13, 14 or 15 depending on length of baseline.

  • Self-Compassion Scale for Youth

    At initial baseline, first week pre-intervention and in the final week after intervention has been complete - week 13, 14 or 15 depending on length of baseline.

Study Arms (1)

Compassion Focussed Therapy and Loving Kindness Meditation Intervention

EXPERIMENTAL

Single arm study

Other: Compassion Focussed Therapy/Loving Kindness Meditation

Interventions

After a baseline of 3-5 weeks (randomly allocated) is completed, the participant will engage in three sessions of Compassion Focussed Therapy informed psycho-education and introduction to Loving Kindness Meditation (LKM). Following the third session, the participants will have four weeks to practice LKM, receiving weekly email reminders with guided self-help instructions and reminders to complete outcome measures. A final follow-up session will occur after the four weeks, to consolidate knowledge and skills with the participant, plus gather feedback on the intervention.

Compassion Focussed Therapy and Loving Kindness Meditation Intervention

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years old
  • Have a diagnosis of epilepsy. This is to be confirmed by the recruiting professional who will confirm via the participant's medical records.
  • Currently showing or reporting mild-moderate psychological distress: including anxiety, low mood or stress, in relation to their health condition, as identified by local clinicians recruiting to study.
  • Have access to a computer/internet enabled electronic device e.g. a tablet or mobile phone.
  • English speaker to a standard sufficient to participate in verbal communication without an interpreter.

You may not qualify if:

  • Presence of an Intellectual Disability. As this is a time limited intervention with a set protocol, there will not be opportunity to make adaptations to the intervention. Consistency across the participants is important to show any effect of the intervention.
  • Currently receiving any other mental health treatment in order to reduce extraneous variables from other mental health treatment.
  • Current report of self-harming behaviours as the research cannot monitor or manage risk.
  • Severe psychological distress e.g. depression, psychosis or an eating disorder, as this is likely to require specialist psychological support.
  • Seizures are due to Non-Epileptic Attack Disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lincoln

Lincoln, United Kingdom

Location

MeSH Terms

Conditions

EpilepsyPsychological Well-Being

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesPersonal SatisfactionBehavior

Study Officials

  • Nima Moghaddam, DClinPsy

    University of Lincoln

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2025

First Posted

December 4, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

December 4, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations