Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611001086954
Ethics application status
Approved
Date submitted
19/10/2011
Date registered
19/10/2011
Date last updated
23/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Behavioural Therapy for Vestibular Migraine
Scientific title
Assessing the effectiveness of cognitive behavioural therapy to improve the severity and frequency of dizzy spells, dizziness handicap and quality of life in people with vestibular migraine
Secondary ID [1] 273233 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vestibular migraine 278992 0
Depression 278993 0
Anxiety 278994 0
Condition category
Condition code
Neurological 279174 279174 0 0
Other neurological disorders
Mental Health 279175 279175 0 0
Depression
Mental Health 279176 279176 0 0
Anxiety

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 group psychological treatment based on cognitive behavioural therapy principles. This program is specifically designed to try to improve frequency of dizzy spells, dizziness-related handicap, quality of life and psychopathology in the context of vestibular migraine. Each weekly treatment session will be conducted by a psychologist and last 120 minutes. The sessions will include the following components: orientation to therapy and psychoeducation about vestibular migraine and anxiety; behavioural experiments and addressing avoidance through exposure; cognitive therapy strategies to challenge unhelpful beliefs; consolidation of skills developed throughout the program, identification of high risk situations and development of a plan for managing symptoms.
Intervention code [1] 269564 0
Treatment: Other
Intervention code [2] 269568 0
Behaviour
Comparator / control treatment
Wait-list control. Will be offered treatment three months after assessment.
Control group
Active

Outcomes
Primary outcome [1] 279811 0
Migraine frequency. This will be measured using participant self-report diaries and the Migraine Disability Assessment Questionnaire (MIDAS; Lipton et al., 2001) 7-item scale strongly related to migraine frequency.
Timepoint [1] 279811 0
Diary kept one week prior to commencement of the groups and throughout treatment. MIDAS administered pre-treatment (assessment session) at post-treatment (final therapy session) then 3 and 6 months post-treatment.
Primary outcome [2] 279813 0
Dizziness handicap. This will be measured using the Dizziness Handicap Inventory (DHI; Jacobsen & Newman, 1990) 25-item scale to measure self-perceived handicap experienced due to vestibular system disease.
Timepoint [2] 279813 0
Pre-treatment (assessment session) at post-treatment (final therapy session) then 3 and 6 months post-treatment.
Primary outcome [3] 300837 0
Anxiety and depression symptomatology. This will be measured using the Hospital Anxiety Depression Scale (HADS; Zigmond & Snaith, 1983) 14 item self-report measure.
Timepoint [3] 300837 0
Pre-treatment, post-treatment, three and six month follow-up
Secondary outcome [1] 331003 0
Quality of life. This will be measured using the WHOQoL-BREF Australian version (WHO, 2000) 26 item self-report measure.
Timepoint [1] 331003 0
Pre-treatment (assessment session) at post-treatment (post final therapy session) and then 3 and 6 months post-treatment.

Eligibility
Key inclusion criteria
People with vestibular migraine
Minimum age
18 Years
Maximum age
75 Years
Sex
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)
Central randomisation carried out by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/01/2012
Actual
27/08/2012
Date of last participant enrolment
Anticipated
Actual
10/07/2015
Date of last data collection
Anticipated
Actual
24/05/2016
Sample size
Target
70
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7359 0
Royal Prince Alfred Hospital - Camperdown

Funding & Sponsors
Funding source category [1] 270062 0
Self funded/Unfunded
Name [1] 270062 0
Country [1] 270062 0
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 269025 0
University
Name [1] 269025 0
University of Sydney Psychology Clinic
Address [1] 269025 0
Psychology Clinic
Mackie Building K01
University of Sydney
Camperdown NSW 2006
Country [1] 269025 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272018 0
Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 272018 0
Research Development Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 272018 0
Australia
Date submitted for ethics approval [1] 272018 0
26/10/2011
Approval date [1] 272018 0
14/12/2011
Ethics approval number [1] 272018 0
11/RPAH643

Summary
Brief summary
The experience of both migrainous and vestibular symptoms is likely to be associated with greater compromise than for either disorder presenting independently. The impact of VM is compounded due to the current lack of evidence-based treatment that has proven to be definitely efficacious. CBT is likely to be an effective adjunct treatment to medication in the treatment of VM. Trials are urgently needed to provide an evidence-base for such approaches.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33281 0
Prof Louise Sharpe
Address 33281 0
Room 450, Brennan MacCallum (A18)
The University of Sydney
NSW 2006 Australia
Country 33281 0
Australia
Phone 33281 0
+61 2 9351 4558
Fax 33281 0
Email 33281 0
[email protected]
Contact person for public queries
Name 16528 0
Ms Ingrid McPhee
Address 16528 0
School of Psychology
Brennan MacCallum Building (A18)
University of Sydney
Camperdown NSW 2006
Country 16528 0
Australia
Phone 16528 0
+61 02 90367855
Fax 16528 0
Email 16528 0
[email protected]
Contact person for scientific queries
Name 7456 0
Ms Ingrid McPhee
Address 7456 0
School of Psychology
Brennan MacCallum Building (A18)
University of Sydney
Camperdown NSW 2006
Country 7456 0
Australia
Phone 7456 0
+61 02 90367855
Fax 7456 0
Email 7456 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.