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Trial registered on ANZCTR


Registration number
ACTRN12609000389202
Ethics application status
Approved
Date submitted
13/05/2009
Date registered
29/05/2009
Date last updated
16/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Depression in Epilespy
Scientific title
Assessing the effectiveness of Cognitive Behavioural Therapy to improve quality of life and mood in people with epilepsy
Secondary ID [1] 273232 0
Milena Gandy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 4769 0
Depression 4770 0
Quality of Life 4771 0
Condition category
Condition code
Mental Health 237110 237110 0 0
Depression
Neurological 237222 237222 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
If participants agree to take part in this study they will be randomly allocated to one of two conditions, an immediate treatment condition or a waitlist control. The immediate treatment condition involves a detailed assessment of psychological functioning and 8 weeks of individual psychological treatment based on cognitive behavioural therapy principles. This program is specific to improving quality of life and mood in the context of epilepsy. Each weekly treatment session lasts 50 mins. Therapy will include the following elements; completion of weekly seizures & trigger diaries; education about epilepsy and its affects on quality of life, goal-setting; the role and management of lifestyle factors, sleep, alcohol, exercise, diet; implementation of lifestyle management plan, management of ictal / post-ictal mood symptoms; behavioural aspects of mood impairment: role of pleasant events and avoidance; implementation of behavioural management of mood strategies; cognitive aspects of mood impairment: identifying unhelpful thoughts. Behavioural aspects of mood impairment: graded exposure; monitoring unhelpful thoughts with mood diary; cognitive aspects of mood impairment: challenging unhelpful thoughts; challenging unhelpful thoughts with mood diary. Implementation of graded exposure; social aspects of living with epilepsy: talking with others and assertiveness; talking to key others about change to management of epilepsy; relapse prevention strategies; development and practice of relapse prevention strategies; and review and re-setting of goals for future.
Intervention code [1] 4549 0
Treatment: Other
Comparator / control treatment
Waitlist control. They will be offered treatment 4 months following the immediate control condition
Control group
Active

Outcomes
Primary outcome [1] 5941 0
Depressive sympotmolgy. This will be measure using the Hospital Anxiety Depression Scale (HADS; Zigmond & Snaith, 1983) 14 item self-report measure.
Timepoint [1] 5941 0
Pre treatment (assessment session) at post treatment (final therapy session) then 3 and 6 months post treatment
Primary outcome [2] 290988 0
The Neurological Depressive Disorders Inventory NDDI-E (Gilliam et al., 2006).
Timepoint [2] 290988 0
Pre treatment (assessment session) at post treatment (final therapy session) then 3 months post treatment
Secondary outcome [1] 242036 0
Quality of Life. This will be measured using the Quality of Life Inventory in Epilepsy 31 item (Cramer et al., 1998).
Timepoint [1] 242036 0
Pre treatment (assessment session) at post treatment (final therapy session) then 3 and 6 months post treatment

Eligibility
Key inclusion criteria
People with Epilepsy
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
About to undergo major surgery or significant change to medication
Significantly impaired cognitive functioning
psychosis
inability to speak English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible participants were provided with an information and consent form. Those who consented completed the battery of baseline measures. Following completion of baseline measures, participants were randomly allocated to treatment condition. A list of random numbers using the Bernoulli function was generated by an independent researcher who was not involved in the treatment or assessment of the participants. The set of random numbers was consecutively assigned to each new participant. Random allocation was concealed until after participants had completed the baseline data.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

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)

Funding & Sponsors
Funding source category [1] 4955 0
Self funded/Unfunded
Name [1] 4955 0
Address [1] 4955 0
Country [1] 4955 0
Primary sponsor type
Hospital
Name
Royal Prince Alfred
Address
8 East Neurology,
Royal Prince Alfred Hospital
Camperdown
NSW
2050
Country
Australia
Secondary sponsor category [1] 4473 0
University
Name [1] 4473 0
The Psychology Clinic The Univerisy
Address [1] 4473 0
Psychology Clinic
Transient Building F12
Camperdown
2006
Country [1] 4473 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7052 0
Sydney South West Area Health Service Ethics Review Committee (RPAH Zone) X09-0155 & HREC/09/RPAH/247 Ratified by Sydney University Ethics Comittee
Ethics committee address [1] 7052 0
Research Development Office, Royal Prince Alfred Hospital CAMPERDOWN NSW 2050
Ethics committee country [1] 7052 0
Australia
Date submitted for ethics approval [1] 7052 0
27/05/2009
Approval date [1] 7052 0
02/07/2009
Ethics approval number [1] 7052 0
HREC/09/RPAH/247

Summary
Brief summary
The effectiveness of psychological treatments for depression in People with epilepsy (PWE) is currently unknown, although there are some encouraging results to suggest that Cognitive Behavioural Therapy (CBT) might have a useful role (Ramarantnam, Baker, & Goldstein, 2008). This study aims to assess the effectiveness of a CBT intervention to improve Quality of Life (QoL) and mood in people with epilepsy. This study will be the first to help us to assess the effectiveness of CBT interventions in an Australian sample to improve quality of life and mood in PWE. In addition, it will help us to develop an understanding of two important additional questions: do particular sub-groups benefit more than others from CBT and what are the mechanisms of treatment change? The costs of depression in epilepsy are high both for the individuals concerned, in terms of quality of life and seizure activity, but also for society due to greater economic and health care costs in those with untreated depression and epilepsy (Cramer, Blum, Fanning, & Reed, 2004). Neurologists report that they tend not to screen for depression due to lack of available resources for its treatment (Gilliam et al., 2004), and so the development of an effective and available local service may increase the overall rates of detection and treatment in this group.
Trial website
Trial related presentations / publications
28/05/2013. Title Presentation: Depression In Epilepsy: Clinical Applications presented at the annual Psychologist Network Training Day for the Sydney and South Western Sydney Local Health Districts Area.
04/07/2013. Title Presentation: The Identification, Prediction and Management of Depression in People with Epilepsy at the Royal Prince Alfred Hospital.
21/11/2012. Presentation Title: A randomized controlled trial of Cognitive Behavioural Therapy to improve depression in adults with epilepsy at The Fifth Annual Sydney Postgraduate Psychology Conference.
01/09/2012. Presented the results of my PhD randomized controlled trial of Cognitive Behavioral Therapy to Improve Depression in Adults with Epilepsy at Psychotherapy & Neuroscience: Evidence & Challenges for CBT: 42nd European Association of Behavioral and Cognitive Therapy Switzerland.
11/2011. Presented Preliminary findings of my PhD The Identification, Prediction and Management of Depression in People with Epilepsy at Fourth Annual Sydney Postgraduate Psychology Conference
24/11/2010. Presentation Presented the rationale and methodological plans for my PhD research The Third Annual Sydney Postgraduate Psychology Conference

Publications:
Gandy, M., Sharpe, L., Nicholson Perry, K., (2013). Cognitive behavior therapy for depression in people with epilepsy: a systematic review. Epilepsia, 54(10) 1725-34.
Gandy, M., Sharpe, L., Nicholson Perry, K., Miller, L., Thayer, Z., Boserio, J., et al. (2013). The psychosocial predictors of depression and suicidality in people with epilepsy. Journal of Psychosomatic Research, 74(3) 227-232.
Gandy, M., Sharpe, L., Nicholson Perry, K, Miller, L., Thayer, Z., Boserio, J., et al. (2013). Rates of DSM-IV mood, anxiety disorders and suicidality in Australian adult epilepsy outpatients: A comparison of well-controlled versus refractory epilepsy. Epilepsy & Behaviour, 26(1), 29-53.
Gandy, M., Sharpe, L., Nicholson Perry, K., Miller, L, Thayer, Z, Boserio, J.et al. (2012). Assessing the efficacy of 2 screening measures for depression in people with epilepsy. Neurology, 79(4), 371-375.
Gandy, M., Sharpe, L., & Nicholson Perry, K. (2012). Psychosocial predictors of depression and anxiety in patients with epilepsy: A systematic review. Journal of Affective Disorders, 140(3), 222-232.
Public notes

Contacts
Principal investigator
Name 29602 0
Dr Milena Gandy
Address 29602 0
Centre for Emotional Health
eCentreClinic,
Department of Psychology,
Macquarie University NSW 2109.
Country 29602 0
Australia
Phone 29602 0
+ 61 2 98504152
Fax 29602 0
Email 29602 0
milena.gandy@mq.edu.au
Contact person for public queries
Name 12849 0
Dr Milena Gandy
Address 12849 0
Centre for Emotional Health
eCentreClinic,
Department of Psychology,
Macquarie University NSW 2109.
Country 12849 0
Australia
Phone 12849 0
+61 2 98504152
Fax 12849 0
Email 12849 0
milena.gandy@mq.edu.au
Contact person for scientific queries
Name 3777 0
Dr Milena Gandy
Address 3777 0
Centre for Emotional Health
eCentreClinic,
Department of Psychology,
Macquarie University NSW 2109.
Country 3777 0
Australia
Phone 3777 0
+61 298504152
Fax 3777 0
Email 3777 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