ThinkNinja for epilepsy: a cognitive behavioural therapy app to improve mental health in epilepsy

Not Applicable

Completed

• Conditions: Mental health problems in people with epilepsy; Mental and Behavioural Disorders

• Registration Number: ISRCTN16270209
• Lead Sponsor: Healios Ltd

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36409536/ (added 22/11/2022)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-04
• Study Completion: 2023-04-30
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

Current inclusion criteria as of 16/05/2022:
1. Adult aged 18-65 years
2. UK resident
3. Fluent in English
4. Scoring =5 on the GAD-7 indicating at least mild anxiety at screen-in (incl. diagnosed/non-diagnosed)
5. The participant is willing and able to receive notifications and email messages
6. Have a confirmed Epilepsy diagnosis (6 months minimum time since diagnosis, suspected cases are not permitted). Diagnosis to be confirmed ideally by participant submitting a photograph of their current medication and/or letter/report from their healthcare provider
7. Stable epilepsy and anxiety/depression medication regime (anti-epileptic, antidepressant, anxiolytic drug etc. A stable medication regimen for the present study refers to no change in medication in the last 4 weeks. Questions to cover this at all data collection time points. Should participants change medication during the study period, this will not affect their inclusion, however, this will be explored in the analysis.

Previous inclusion criteria:
1. Adult aged 18-65 years
2. UK resident
3. Fluent in English
4. Clinical levels of anxiety (=10 on the GAD-7) at screen-in (incl. diagnosed/non-diagnosed)
5. The participant is willing and able to receive notifications and email messages
6. Have a confirmed Epilepsy diagnosis (6 months minimum time since diagnosis, suspected cases are not permitted). Diagnosis to be confirmed ideally by participant submitting a photograph of their current medication and/or letter/report from their healthcare provider
7. Stable epilepsy and anxiety/depression medication regime (anti-epileptic, antidepressant, anxiolytic drug etc. A stable medication regimen for the present study refers to no change in medication in the last 4 weeks. Questions to cover this at all data collection time points. Should participants change medication during the study period, this will not affect their inclusion, however, this will be explored in the analysis.

Exclusion Criteria

1. Have a subclinical score on the GAD-7 at screening
2. Have a score =20 on the PHQ-9 indicating severe depression at screen in or if they answer ‘more than half of the days’ or ‘nearly every day’’ to the question ‘Over the last 2 weeks, how often have you been bothered by thoughts that you would be better off dead or of hurting yourself in some way?’
3. Sensitivity to mobile phone screen exposure
4. Currently receiving counselling or psychological therapy (however, will not be excluded if they seek support during the study)
5. Individuals involved in current or ongoing research
6. Pregnant or has given birth in the past 12 months
7. Diagnosis of a severe mental illness (severe depression including suicidal ideation, schizophrenia, bipolar, psychosis, personality disorder, PTSD, substance misuse)
8. Severe learning disability and individuals requiring a carer for their epilepsy
9. Does not have access to a smartphone (iPhone with iOS 9 or greater capabilities, or an Android with OS 7 or greater capabilities)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life measured by the Quality of Life in Epilepsy questionnaire (QOLIE-10-P) at baseline (T0), 4 weeks after the beginning of the intervention (T1), at the completion of the intervention (T2) and at follow-up 8 weeks post study (T3)

Secondary Outcome Measures

Name	Time	Method
1. Anxiety measured using the Generalised Anxiety Disorder Assessment (GAD-7) at baseline (T0), 4 weeks after the beginning of the intervention (T1), at the completion of the intervention (T2) and at follow-up 8 weeks post study (T3)<br>2. Depression measured using the Patients Health Questionnaire (PHQ-9) at baseline (T0), 4 weeks after the beginning of the intervention (T1), at the completion of the intervention (T2) and at follow-up 8 weeks post study (T3)<br>3. Medication adherence measured using the Medical Acceptability Questionnaire (MAQ) at baseline (T0), 4 weeks after the beginning of the intervention (T1), at the completion of the intervention (T2) and at follow-up 8 weeks post study (T3)<br>4. Impression of change measured using the Patients’ Global Impression of Change (PGIC) at the completion of the intervention (T2) and at follow-up 8 weeks post study (T3)