ANZCTR - Registration

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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]

Milena Gandy

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Epilepsy

Depression

Quality of Life

Condition category

Condition code

Mental Health

Depression

Neurological

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]

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]

Depressive sympotmolgy. This will be measure using the Hospital Anxiety Depression Scale (HADS; Zigmond & Snaith, 1983) 14 item self-report measure.

Timepoint [1]

Pre treatment (assessment session) at post treatment (final therapy session) then 3 and 6 months post treatment

Primary outcome [2]

The Neurological Depressive Disorders Inventory NDDI-E (Gilliam et al., 2006).

Timepoint [2]

Pre treatment (assessment session) at post treatment (final therapy session) then 3 months post treatment

Secondary outcome [1]

Quality of Life. This will be measured using the Quality of Life Inventory in Epilepsy 31 item (Cramer et al., 1998).

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/06/2009

Actual

10/01/2011

Date of last participant enrolment

Anticipated

Actual

21/12/2011

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]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

University

Name [1]

The Psychology Clinic The Univerisy

Address [1]

Psychology Clinic
Transient Building F12
Camperdown
2006

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

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]

Research Development Office, Royal Prince Alfred Hospital CAMPERDOWN NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/05/2009

Approval date [1]

02/07/2009

Ethics approval number [1]

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

Dr Milena Gandy

Address

Centre for Emotional Health
eCentreClinic,
Department of Psychology,
Macquarie University NSW 2109.

Country

Australia

Phone

+ 61 2 98504152

Fax

milena.gandy@mq.edu.au

Contact person for public queries

Name

Milena Gandy

Address

Centre for Emotional Health
eCentreClinic,
Department of Psychology,
Macquarie University NSW 2109.

Country

Australia

Phone

+61 2 98504152

Fax

milena.gandy@mq.edu.au

Contact person for scientific queries

Name

Milena Gandy

Address

Centre for Emotional Health
eCentreClinic,
Department of Psychology,
Macquarie University NSW 2109.

Country

Australia

Phone

+61 298504152

Fax

milena.gandy@mq.edu.au

No information has been provided regarding IPD availability

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No Supporting Document Provided

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