EpilepsyPIENCT02349529
An Exploratory RCT of a Psychosocial Group Intervention for Epilepsy
A study testing Psychosocial Intervention Group in people with Epilepsy, run by NHS Greater Glasgow and Clyde.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Psychosocial Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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:
- Postnatally acquired structural lesions (e.g. TBI or neurooncological conditions)
- Immune mediated disorders (e.g. limbic or antiNMDAR encephalopathy)
- Metabolic disorders (e.g. GLUT1 deficiency)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Exploratory Randomised Controlled Trial of a Manualised Psychosocial Group Intervention for Young People With Epilepsy (PIE)
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.
- Conditions
- Epilepsy
- Being tested
- Psychosocial Intervention Group, Waiting list control
- Keywords
- Epilepsy, psychosocial
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial Intervention GroupBehavioural
6 group sessions
Waiting list controlOther
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial group intervention | Experimental | Not described Receives: Behavioral: Psychosocial Intervention Group |
| Waiting List control | Other | 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. Receives: Other: Waiting list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Effectiveness of the PIE group
Measured: 6 weeks
Effectiveness of the PIE group
Measured: 3 months
Effectiveness of the PIE group
Measured: 6 months
Secondary outcomes (6)
The Paediatric Index of Emotional Distress (PIED).
Measured: Baseline, 6 weeks, 3 months and 6 months
The Seizure Self Efficacy Scale for Children (SSEC)
Measured: Baseline, 6 weeks, 3 months and 6 months
Epilepsy Knowledge ProfileGeneral (EKPG)
Measured: Baseline, 6 weeks, 3 months and 6 months
Brief Illness Representations Questionnaire (BIPQ).
Measured: Baseline, 6 weeks, 3 months and 6 months
Participant social functioning
Measured: Baseline, 6 weeks, 3 months and 6 months
seizure control
Measured: Baseline, 6 weeks, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liam Dorris, BSc (Hons), D.Clin.Psy, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349529
- Sponsor's protocol ID
- GN12KH157
- Acronym
- PIE
- Status last verified
- Jan 2015
- First submitted
- 19 Jan 2015
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Randomised Controlled Trial of a Manualised Psychosocial Group Intervention for Young People With Epilepsy (PIE)
- ClinicalTrials.gov ID
- NCT02349529
- Acronym / sponsor ID
- PIE / GN12KH157
- Conditions
- Epilepsy
- Keywords
- Epilepsy, psychosocial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosocial group intervention | Experimental | Behavioral: Psychosocial Intervention Group |
| Waiting List control | Other | Other: Waiting list controlParticipants 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial Intervention Group6 group sessions | Behavioural | Psychosocial group intervention |
| Waiting list controlTreatment as usual | Other | Waiting List control |
Primary outcome
Effectiveness of the PIE group
Time frame: Baseline
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
Effectiveness of the PIE group
Time frame: 6 weeks
Effectiveness of the PIE group
Time frame: 3 months
Effectiveness of the PIE group
Time frame: 6 months
6 secondary outcomes
The Paediatric Index of Emotional Distress (PIED).
Time frame: Baseline, 6 weeks, 3 months and 6 months
The Seizure Self Efficacy Scale for Children (SSEC)
Time frame: Baseline, 6 weeks, 3 months and 6 months
Epilepsy Knowledge ProfileGeneral (EKPG)
Time frame: Baseline, 6 weeks, 3 months and 6 months
Brief Illness Representations Questionnaire (BIPQ).
Time frame: Baseline, 6 weeks, 3 months and 6 months
Participant social functioning
Time frame: Baseline, 6 weeks, 3 months and 6 months
seizure control
Time frame: Baseline, 6 weeks, 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
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Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liam Dorris, BSc (Hons), D.Clin.Psy principal investigator
NHS Greater Glasgow and Clyde
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Intervention Group in people with Epilepsy, run by NHS Greater Glasgow and Clyde.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liam Dorris, BSc (Hons), D.Clin.Psy (01412010638, liam.dorris@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the PIE group (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2015.