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Trial registered on ANZCTR


Registration number
ACTRN12610000393055
Ethics application status
Approved
Date submitted
13/05/2010
Date registered
17/05/2010
Date last updated
17/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Behavioural management of the triggers of recurrent headache: Avoidance versus coping
Scientific title
Evaluating an avoidance versus coping based approach to the behavioural management of triggers for migraine and tension-type headaches, by measuring the primary outcomes of: (a) daily headache activity; (b) headache medication use; and (c) impact of headache on daily living
Secondary ID [1] 251740 0
Nil
Universal Trial Number (UTN)
U1111-1114-9842
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraines 257348 0
Tension-type headaches 257349 0
Condition category
Condition code
Other 257494 257494 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Neurological 257522 257522 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1: Three 30-minute sessions scheduled for weeks 1, 4 and 8. Advice is given to avoid headache triggers and on how to accomplish avoidance, administered in an individual format by a registered psychologist. Intervention 2: 8 weekly sessions of cognitive behaviour therapy, relaxation techniques and exposure as an opportunity to practice coping skills or when not possible avoidance, administered in an individual format by a registered psychologist. Each session will be 60 minutes in duration. Intervention 3: Eight 60-minute weekly sessions of cognitive behaviour therapy and relaxation, administered in an individual format by a registered psychologist.
Intervention code [1] 256460 0
Treatment: Other
Comparator / control treatment
Control condition: no treatment
Control group
Active

Outcomes
Primary outcome [1] 258411 0
Self-monitoring diary of daily headache severity.
Timepoint [1] 258411 0
Baseline (for 4 weeks prior to commencement of treatment), throughout treatment, immediately post treatment (for 4 weeks), 4 and 12 months post treatment (for 4 weeks each time). 'Throughout treatment' means monitoring this on a daily basis over the 8 weeks of treatment.
Primary outcome [2] 258412 0
Self-monitoring diary of daily medication consumption.
Timepoint [2] 258412 0
Baseline (for 4 weeks prior to commencement of treatment), throughout treatment, immediately post treatment (for 4 weeks), 4 and 12 months post treatment (for 4 weeks each time). 'Throughout treatment' means monitoring this on a daily basis over the 8 weeks of treatment.
Primary outcome [3] 258413 0
Self-monitoring diary of daily headache triggers presence.
Timepoint [3] 258413 0
Baseline (for 4 weeks prior to commencement of treatment), throughout treatment (for 8 weeks), immediately post treatment (for 4 weeks), 4 and 12 months post treatment (for 4 weeks each time).
Secondary outcome [1] 264165 0
Headache Self-Efficacy Scale (HSESv2).
Timepoint [1] 264165 0
Baseline, immediately post treatment, 4 and 12 months post treatment.
Secondary outcome [2] 264166 0
Headache-Specific Locus of Control (HSLC).
Timepoint [2] 264166 0
Baseline, immediately post treatment, 4 and 12 months post treatment.
Secondary outcome [3] 264167 0
Headache Disability Inventory (HDI).
Timepoint [3] 264167 0
Baseline, immediately post treatment, 4 and 12 months post treatment.
Secondary outcome [4] 264168 0
Short-Form Health Survey (SF-36v2).
Timepoint [4] 264168 0
Baseline, immediately post treatment, 4 and 12 months post treatment.
Secondary outcome [5] 264169 0
Personal Wellbeing Index (PWI).
Timepoint [5] 264169 0
Baseline, immediately post treatment, 4 and 12 months post treatment.
Secondary outcome [6] 264170 0
Headache Triggers Avoidance Questionnaire (HTAQ).
Timepoint [6] 264170 0
Baseline, immediately post treatment, 4 and 12 months post treatment.

Eligibility
Key inclusion criteria
Inclusion criteria: (i) diagnosed as either ‘migraine without aura’, ‘probable migraine without aura’, ‘typical aura with migraine headache’, ‘probable migraine with aura’, ‘chronic migraine’, ‘frequent episodic tension-type headache’, probable frequent episodic tension-type headache’, ‘chronic tension-type headache’, ‘probable ergotamine-overuse headache’, ‘probable triptan -overuse headache’, ‘probable analgesic -overuse headache’, ‘probable opioid-overuse headache’, ‘probable combination analgesic-overuse headache’, ‘headache probably attributed to overuse of acute medication combinations’, ‘headache probably attributed to other medication overuse- Headache Classification Subcommittee of the International Headache Society (IHS), 2005; (ii) minimum of 6 headache days per month; (iii) minimum headache chronicity of 12 months, and pattern of headache symptoms stable over last 6 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: (i) pregnant, planning pregnancy during trial period or lactating; (ii) currently taking headache prophylactic medication (one month wash-out period required); (iii) currently receiving psychological or psychiatric treatment.

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 will occur off-site via computer. The co-investigator with statistical responsibility and no involvement with participants will take responsibility for randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Use of a randomisation table created by computer software (computer sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256953 0
Government body
Name [1] 256953 0
NHMRC
Country [1] 256953 0
Australia
Primary sponsor type
Individual
Name
Professor Paul Martin (Principal Investigator)
Address
Department of Psychological Medicine, Monash Medical Centre, 246 Clayton Road, Clayton, Victoria 3168
Country
Australia
Secondary sponsor category [1] 256217 0
Individual
Name [1] 256217 0
Professor Peter Goadsby (Co-investigator)
Address [1] 256217 0
Institute of Neurology, University College London, Queen Square, London, WC1N 3BG, UK
Country [1] 256217 0
United Kingdom
Secondary sponsor category [2] 256218 0
Individual
Name [2] 256218 0
Professor Colin MacLeod (Co-investigator)
Address [2] 256218 0
School of Psychology, University of western Australia, 35 Stirling Highway, Crawley, WA, 6009
Country [2] 256218 0
Australia
Secondary sponsor category [3] 256219 0
Individual
Name [3] 256219 0
Associate Professor John Reece (Co-investigator)
Address [3] 256219 0
Division of Psychology, RMIT University, Bundoora Campus, PO Box 71, Bundoora, Vic, 3083
Country [3] 256219 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258954 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 258954 0
Human Ethics Committee, First Floor, Building 3E, Room 111,Monash University, Vic, 3800
Ethics committee country [1] 258954 0
Australia
Date submitted for ethics approval [1] 258954 0
Approval date [1] 258954 0
15/05/2009
Ethics approval number [1] 258954 0
CF09/0964-2009000447

Summary
Brief summary
The standard clinical advice for individuals who suffer from recurrent headaches is that ‘the best way to prevent headaches is to avoid the triggers’. There is a plausible argument that such advice may be counter to the interests of headache suffers as it could lead to increased sensitisation and decreased tolerance of headache triggers and therefore more headaches. Research results suggest that it should be possible to increase individual’s tolerance of headache triggers through prolonged exposure for desensitisation or providing exposure as an opportunity to practice coping with headache triggers. The proposed study seeks to compare a psychological treatment that advocates avoidance of headache triggers, with a coping approach that uses exposure to triggers (supported by relaxation and cognitive techniques) except where this is not possible or would seem inappropriate. It is predicted that exposure will increase tolerance to headache triggers and lead to fewer headaches in the long term, whereas avoidance may at best provide short term relief. The study results will have important implications for our understanding of how headache disorders can be more effectively managed in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31152 0
Address 31152 0
Country 31152 0
Phone 31152 0
Fax 31152 0
Email 31152 0
Contact person for public queries
Name 14399 0
Professor Paul Martin
Address 14399 0
Department of Psychological Medicine, Monash Medical Centre, 246 Clayton Road, Clayton, Victoria 3168
Country 14399 0
Australia
Phone 14399 0
+61 3 95941468
Fax 14399 0
+61 3 95946499
Email 14399 0
[email protected]
Contact person for scientific queries
Name 5327 0
Professor Paul Martin
Address 5327 0
Department of Psychological Medicine, Monash Medical Centre, 246 Clayton Road, Clayton, Victoria 3168
Country 5327 0
Australia
Phone 5327 0
+61 3 95941468
Fax 5327 0
+61 3 95946499
Email 5327 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

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