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Trial registered on ANZCTR


Registration number
ACTRN12614001300662
Ethics application status
Approved
Date submitted
8/12/2014
Date registered
12/12/2014
Date last updated
9/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the Feasibility of an Internet-Delivered Cognitive Behaviour Therapy program for emotional wellbeing among people with epilepsy.
Scientific title
An open trial examining the feasibility of an internet-delivered Cognitive Behaviour Therapy (iCBT) program for adults with epilepsy aimed at improving emotional wellbeing.
Secondary ID [1] 285791 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 293681 0
Anxiety 293682 0
Depression 293683 0
Condition category
Condition code
Mental Health 293979 293979 0 0
Depression
Mental Health 293980 293980 0 0
Anxiety
Neurological 293981 293981 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be assigned to one group, who will receive an internet-delivered Cognitive Behaviour Therapy program, the Managing Your Wellbeing Epilepsy Course. All participants will have a diagnosis of epilepsy. Participants will complete 5 lessons of Internet based treatment about management of symptoms of anxiety and depression in the context of living with a chronic health condition (epilepsy). One lesson will be completed every 7 to 10 days. Each lesson will take about 15 minutes to complete. Participants will also have access to summaries of each lesson, and will read anonymous stories about other people with chronic health conditions, including epilepsy, taking a further 20 minutes per summary.

Online monitoring will occur to monitor lessons completed and treatment adherence. When each participant clicks through all the slides of each lesson the computer will log the time spent on the lesson and the time/date when the lesson was completed.

Participants will have the option of weekly telephone calls or emails from a trained and supervised Psychologist at the eCentreClinic to provide support, encouragement and to answer questions about the content of the Course. The duration of the program is 8 weeks. Study questionnaires will be administered at application, pre-treatment, posttreatment, and at 3 month follow-up. Some questionnaires will be administered weekly during the Course. The major sets of questionnaires will take about 10 to 15 minutes to complete. The treatment materials are based on previous internet-based programs, which apply cognitive behavioural techniques.
Intervention code [1] 290754 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293755 0
Patient Health Questionnaire 9-Item (PHQ9) and Neurological Depressive Disorders Inventory for Epilepsy (NDDI-E), which are two measures of depression.
Timepoint [1] 293755 0
Application, pre-treatment, weekly during treatment (PHQ-9), post-treatment and 3 month follow-up.
Primary outcome [2] 293756 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
Timepoint [2] 293756 0
Application, pre-treatment, weekly during treatment, post-treatment and 3 month follow-up.
Primary outcome [3] 293757 0
World Health Organisation Disability Assessment Schedule 2.0 (WHODAS-2), which is a measure of disability associated with living with a chronic health condition.
Timepoint [3] 293757 0
Pre-treatment, post-treatment and 3 month follow-up.
Secondary outcome [1] 311761 0
Liverpool Seizure Severity (LSSS), which is a measure of patient’s perception of seizure severity.
Timepoint [1] 311761 0
Application, pre-treatment, post-treatment and 3 month follow-up.


Secondary outcome [2] 311762 0
Seizure Frequency Questionnaire (SFQ) and Weekly Seizure Frequency Questionnaire (WSFQ), which are two brief purpose built measures to assess seizure activity.
Timepoint [2] 311762 0
The SFQ will be administered at application, pre-treatment, post-treatment and 3 month follow-up. The WSFQ will be administered weekly during treatment.
Secondary outcome [3] 311763 0
Satisfaction with Life Questionnaire (SWL), which is a measure of of satisfaction with life.
Timepoint [3] 311763 0
Pre-treatment, post-treatment and 3 month follow-up.
Secondary outcome [4] 311766 0
Service Use Questionnaire (SUQ), which is a measure to assess participants’ use of specific medications and treatment services.
Timepoint [4] 311766 0
Pre-treatment, post-treatment and 3 month follow-up.
Secondary outcome [5] 311767 0
Treatment Satisfaction Questionnaires (TSQ), which measures the acceptability of online treatment Courses and participants’ satisfaction with treatment.
Timepoint [5] 311767 0
Post-treatment, 3 month follow up
Secondary outcome [6] 315431 0
Perceived Difficulties Questionnaire (PDQ)
Timepoint [6] 315431 0
pre-treatment, post-treatment, 3 month follow up.

Eligibility
Key inclusion criteria
- 18+ years of age.
- Confirmed diagnosis of epilepsy; which is being managed by a GP or specialist.
- Living in Australia.
- Has had a recent consultation (i.e., in the last 6 months) with a GP or specialist.
- Provide informed consent to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inability to use a computer.
- Severe depression (i.e., indicated by a score > 22 on the PHQ-9).
- Significant suicidal ideation (i.e., indicated by a score > 2 to Question 9 of the PHQ-9).
- Acutely suicidal or recent history of attempted suicide or self-harm (i.e., last 12 months).
- Serious cognitive impairment or dementia (<21 on the Telephone Interview of Cognitive Status; TICS).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply online via the clinic's website
(www.ecentreclinic.org.au). Successful applications are followed by a telephone interview to confirm suitability for the trial. Participants who met inclusion criteria will be allocated to one group (i.e., the Managing Your Wellbeing - Epilepsy Course).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As open trial, no randomisation sequence required
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All analyses will be carried out using conservative intention-to-treat principles and using mixed-linear models analyses to handle missing data. Mixed-models are a robust statistical approach for analysing clinical.

With alpha set at .05, power set at .80 and a sample size of 30, the study is powered to enable the detection of moderate-to-large effect size (i.e., Cohen’s d > 0.50) differences in symptoms of anxiety, depression and disability from pre-treatment to post-treatment and follow-up. The project is, therefore, well powered.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 290354 0
University
Name [1] 290354 0
Macquarie University
Address [1] 290354 0
eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University, NSW, 2109, Australia.
Country [1] 290354 0
Australia
Primary sponsor type
Individual
Name
Dr Milena Gandy
Address
eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University, NSW, 2109, Australia.
Country
Australia
Secondary sponsor category [1] 289077 0
Individual
Name [1] 289077 0
Dr Blake Dear
Address [1] 289077 0
Department of Psychology
Macquarie University
Balaclava Road, North Ryde, NSW, 2109, Australia.
Country [1] 289077 0
Australia
Secondary sponsor category [2] 289078 0
University
Name [2] 289078 0
Macquarie University
Address [2] 289078 0
eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University, North Ryde, NSW, 2109, Australia.
Country [2] 289078 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292056 0
Macquarie University, HUman Research Ethics Committee
Ethics committee address [1] 292056 0
Human Research Ethics Committee
Level 3, Research Hub, Building C5C, Macquarie University, North Ryde, NSW, 2109.
Ethics committee country [1] 292056 0
Australia
Date submitted for ethics approval [1] 292056 0
Approval date [1] 292056 0
30/09/2014
Ethics approval number [1] 292056 0
5201400820

Summary
Brief summary
The purpose of the proposed project is to examine the acceptability, efficacy and feasibility of a low-intensity Cognitive Behaviour Therapy (CBT)-based self-management program, the Managing Your Wellbeing Epilepsy Course, in reducing symptoms of anxiety, depression and disability among adults with epilepsy. The Course contains a 5-lesson 8 week CBT program, which can be administered via the internet. Participants will have brief weekly contact with a clinical psychologist as they work through the Course. We expect participants will rate the Course as acceptable and will report that it was worth their time. We also expect that overall sample will make improvements in symptoms of disability, anxiety and depression from pre-treatment to post-treatment, which will be maintained at 3-month.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
Gandy, M., Sharpe, L., Nicholson Perry, K., Miller, L, Thayer, Z, Boserio, J., & Mohamed, A. [2014]: Cognitive Behaviour Therapy to Improve Mood in People with Epilepsy: A Randomized Controlled Trial. Cognitive Behaviour Therapy, 43[2], 153-166

Gandy, M., Sharpe, L., & Nicholson Perry, K. [2013]. Cognitive behavior therapy for depression in people with epilepsy: A systematic review. Epilepsia, 54, 1725-1734

Dear, B. F., Titov, N., Nicholson Perry, K., Johnston, L., Wootton, B. M., Terides, M. D. Hudson, J. L. (2013). The Pain Course: A randomised controlled trial of a clinician-guided Internet-delivered cognitive behaviour therapy program for managing chronic pain and emotional well-being. Pain, 154(6), 942-950
Public notes

Contacts
Principal investigator
Name 53286 0
Dr Milena Gandy
Address 53286 0
Department of Psychology, Macquarie University, NSW 2109, Australia.
Country 53286 0
Australia
Phone 53286 0
+61 2 9850 4152
Fax 53286 0
Email 53286 0
milena.gandy@mq.edu.au
Contact person for public queries
Name 53287 0
Dr Milena Gandy
Address 53287 0
Department of Psychology, Macquarie University, NSW 2109, Australia.
Country 53287 0
Australia
Phone 53287 0
+61 2 9850 4152
Fax 53287 0
Email 53287 0
milena.gandy@mq.edu.au
Contact person for scientific queries
Name 53288 0
Dr Milena Gandy
Address 53288 0
Department of Psychology, Macquarie University, NSW 2109, Australia.
Country 53288 0
Australia
Phone 53288 0
+61 2 9850 4152
Fax 53288 0
Email 53288 0
milena.gandy@mq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary