Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000098437
Ethics application status
Approved
Date submitted
25/01/2007
Date registered
30/01/2007
Date last updated
30/01/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving Treatment for Headache by Helping Sufferers Enlist Support from Family and Friends.
Scientific title
Evaluating the impact of incorporating social support into cognitive behaviour therapy for tension-type headache, by measuring the primary outcomes of: (a) daily headache activity; (b) headache medication use; and (c) impact of headache on daily living.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tension-type headache 1593 0
Condition category
Condition code
Other 1696 1696 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1: 12 weekly sessions of cognitive behaviour therapy, administered in an individual format by a registered psychologist. Each session will be 50 minutes in duration.
Intervention 2: 8 weekly sessions of cognitive behaviour therapy and 4 weekly sessions of social support training, administered in an individual format by a registered psychologist. Each session will be 50 minutes in duration.
Intervention code [1] 1574 0
Treatment: Other
Comparator / control treatment
Control condition: no treatment.
Control group
Active

Outcomes
Primary outcome [1] 2348 0
Self-monitoring of daily headache activity.
Timepoint [1] 2348 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 a 2 week period each time). 'Throughout treatment' means monitoring this on a daily basis over the 12 weeks of treatment.
Primary outcome [2] 2349 0
Headache Disability Inventory (HDI).
Timepoint [2] 2349 0
Baseline, immediately post treatment, 4 and 12 months post treatment.
Primary outcome [3] 2350 0
Self-monitoring of medication use.
Timepoint [3] 2350 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 a 2 week period each time). 'Throughout treatment' means monitoring this on a daily basis over the 12 weeks of treatment.
Secondary outcome [1] 4092 0
Life Events Inventory (LEI).
Timepoint [1] 4092 0
Measurement timepoints: baseline, immediately post treatment, 4 and 12 months post treatment.
Secondary outcome [2] 4093 0
Coping Strategies Inventory (CSI).
Timepoint [2] 4093 0
Measurement timepoints: baseline, immediately post treatment, 4 and 12 months post treatment.
Secondary outcome [3] 4094 0
Interpersonal Support Evaluation List (ISEL).
Timepoint [3] 4094 0
Measurement timepoints: baseline, immediately post treatment, 4 and 12 months post treatment.
Secondary outcome [4] 4095 0
Social Support Questionnaire (SSQ).
Timepoint [4] 4095 0
Measurement timepoints: baseline, immediately post treatment, 4 and 12 months post treatment.
Secondary outcome [5] 4096 0
Short-Form Health Survey (SF-36).
Timepoint [5] 4096 0
Measurement timepoints: baseline, immediately post treatment, 4 and 12 months post treatment.

Eligibility
Key inclusion criteria
Inclusion criteria: (i) diagnosed by a neurologist as either ‘frequent episodic tension–type headache’ or ‘chronic tension-type headache’; (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) substantial medical or psychiatric comorbidities that are deemed likely to interfere with ability to fully participate; (iii) currently taking headache prophylactic medication (one month wash-out period required).

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 Associate 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
The assessor will be blinded.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1836 0
University
Name [1] 1836 0
Monash University
Country [1] 1836 0
Funding source category [2] 1837 0
Government body
Name [2] 1837 0
NHMRC grant to be submitted in 2007
Country [2] 1837 0
Primary sponsor type
Individual
Name
Professor Paul R. Martin (Principal Investigator).
Address
Country
Secondary sponsor category [1] 1657 0
Individual
Name [1] 1657 0
Dr Thanh Phan (Principal Investigator).
Address [1] 1657 0
Country [1] 1657 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3436 0
Organisation: Southern Health.
Site: Monash Medical Centre Clayton.
Ethics committee address [1] 3436 0
Ethics committee country [1] 3436 0
Australia
Date submitted for ethics approval [1] 3436 0
Approval date [1] 3436 0
05/01/2007
Ethics approval number [1] 3436 0
*06188C

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27508 0
Address 27508 0
Country 27508 0
Phone 27508 0
Fax 27508 0
Email 27508 0
Contact person for public queries
Name 10763 0
Professor Paul R. Martin
Address 10763 0
Department of Psychological Medicine
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 10763 0
Australia
Phone 10763 0
+61 3 95941468
Fax 10763 0
+61 3 95946499
Email 10763 0
Paul.Martin@med.monash.edu.au
Contact person for scientific queries
Name 1691 0
Professor Paul R. Martin
Address 1691 0
Department of Psychological Medicine, Monash Medical Centre, 246 Clayton Road, Clayton VIC 3168
Country 1691 0
Australia
Phone 1691 0
+61 3 95941468
Fax 1691 0
+61 3 95946499
Email 1691 0
Paul.Martin@med.monash.edu.au

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.