Trial Review

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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
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
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

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

Documents added automatically
No additional documents have been identified.