An Exploratory RCT of a Psychosocial Group Intervention for Epilepsy (PIE)

NHS Trust

Status: Unknown

Conditions: Epilepsy

Treatments: Other: Waiting list control; Behavioral: Psychosocial Intervention Group

Study type: Interventional

Funder types: Other

Identifiers

NCT02349529

GN12KH157

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Psychosocial group intervention

Experimental group

Treatment:

Behavioral: Psychosocial Intervention Group

Waiting List control

Other group

Description:

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.

Treatment:

Other: Waiting list control