An Exploratory RCT of a Psychosocial Group Intervention for Epilepsy

Not Applicable

• Conditions: Epilepsy
• Interventions: Behavioral: Psychosocial Intervention Group; Other: Waiting list control

• Registration Number: NCT02349529
• Lead Sponsor: NHS Greater Glasgow and Clyde

Brief Summary

Children and young people with epilepsy are at increased risk of poorer outcomes related to emotional and psychological adjustment, peer relationship problems, lower academic attainment and mental health problems across the lifespan. Despite the well understood risks, there continues to be a lack of psychological and psychosocial support for young people with epilepsy, and a corresponding lack of evidence regarding the effectiveness of psychosocial interventions. This study aims to evaluate a manualised psychosocial group intervention for adolescents with epilepsy. A cognitive behaviour therapy approach is used, aimed at increasing awareness of how epilepsy may impact upon thoughts, feelings and activities and to develop strategies for improved psychological adjustment. In addition, an epilepsy knowledge component aimed at improving a sense of control and epilepsy self-management is included. A group delivery format allows an opportunity for social modelling, and social problem solving, helping others and relating to other young people with similar experiences. The social learning context and availability of knowledgable facilitators (an epilepsy nurse specialist and clinical psychologist) are also key aspects of the intervention. The study will allow us to establish a standard manualised group intervention that can be used throughout the UK which aims to; establish the effectiveness and desirability of this approach; improve the overall quality of life, psychological health and social integration of young people with epilepsy; and to improve epilepsy knowledge and selfmanagement skills aimed at maximising seizure control and overall management.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-01
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-23
• Last Update Submitted: 2015-01-23
• Study First Posted: 2015-01-29
• Last Update Posted: 2015-01-29
• Study Start: 2015-02
• Primary Completion: 2016-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Written informed consent
• Diagnosis of epilepsy (controlled or refractory) of at least 6 months duration
• Between the ages of 1217 years old
• Have a reasonable level of expressive and receptive English language abilities to enable them to fully participate and contribute to the group process
• In mainstream schooling.

Exclusion Criteria

• Formal diagnosis of Learning Disability or attendance at a school for children with Special Educational Needs

• Complex and severe mental health problems;

• Diagnosis of nonepileptic seizures in the absence of epileptic seizures

• Epilepsies occurring in the context of:

  1. Postnatally acquired structural lesions (e.g. TBI or neurooncological conditions)
  2. Immune mediated disorders (e.g. limbic or antiNMDAR encephalopathy)
  3. Metabolic disorders (e.g. GLUT1 deficiency)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychosocial group intervention	Psychosocial Intervention Group	-
Waiting List control	Waiting list control	Participants in the waiting list control will continue in TAU but will then start the intervention once the first group of participants have completed the 3 month follow up in the psychosocial group intervention arm.

Primary Outcome Measures

Name	Time	Method
Effectiveness of the PIE group	6 months

Secondary Outcome Measures

Name	Time	Method
The Paediatric Index of Emotional Distress (PIED).	Baseline, 6 weeks, 3 months and 6 months
The Seizure Self Efficacy Scale for Children (SSEC)	Baseline, 6 weeks, 3 months and 6 months
Epilepsy Knowledge ProfileGeneral (EKPG)	Baseline, 6 weeks, 3 months and 6 months
Brief Illness Representations Questionnaire (BIPQ).	Baseline, 6 weeks, 3 months and 6 months
Participant social functioning	Baseline, 6 weeks, 3 months and 6 months
seizure control	Baseline, 6 weeks, 3 months and 6 months