An Exploratory RCT of a Psychosocial Group Intervention for Epilepsy

Epilepsy Clinical Trial

— PIE  

Official title:

An Exploratory Randomised Controlled Trial of a Manualised Psychosocial Group Intervention for Young People With Epilepsy (PIE)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02349529
• Other study ID #: GN12KH157
• Status: Not yet recruiting
• Phase: N/A
• First received: January 19, 2015
• Last updated: January 23, 2015
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: January 2015
• Source: NHS Greater Glasgow and Clyde
• Contact: Liam Dorris, BSc (Hons), D.Clin.Psy
• Phone: 01412010638
• Email: liam.dorris[@]ggc.scot.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Epilepsy

Intervention

Behavioral:
• Psychosocial Intervention Group
6 group sessions

Other:
• Waiting list control
Treatment as usual

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of the PIE group	Comparing participant's quality of life at baseline, completion of intervention, and at 3 and 6 month post group completion, as measured via the GEOSYP and PedsQL	Baseline	No
Primary	Effectiveness of the PIE group		6 weeks	No
Primary	Effectiveness of the PIE group		3 months	No
Primary	Effectiveness of the PIE group		6 months	No
Secondary	The Paediatric Index of Emotional Distress (PIED).		Baseline, 6 weeks, 3 months and 6 months	No
Secondary	The Seizure Self Efficacy Scale for Children (SSEC)		Baseline, 6 weeks, 3 months and 6 months	No
Secondary	Epilepsy Knowledge ProfileGeneral (EKPG)		Baseline, 6 weeks, 3 months and 6 months	No
Secondary	Brief Illness Representations Questionnaire (BIPQ).		Baseline, 6 weeks, 3 months and 6 months	No
Secondary	Participant social functioning		Baseline, 6 weeks, 3 months and 6 months	No
Secondary	seizure control		Baseline, 6 weeks, 3 months and 6 months	No