Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000435684
Ethics application status
Approved
Date submitted
11/04/2014
Date registered
29/04/2014
Date last updated
13/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing cognitive-behavioural therapy for recurrent headache by integrating into it a new approach to the management of headache triggers (Learning to Cope with Triggers)
Scientific title
Evaluating the impact of incorporating a learning to cope with triggers compared to avoidance of triggers as part of cognitive behavioural therapy for tension-type headache and migraine sufferers by measuring the primary outcomes of (a) daily headache activity; (b) headache medication usage: (c) the presence of triggers and (d) the impact of headache on daily living.
Secondary ID [1] 284425 0
None
Universal Trial Number (UTN)
U1111-1155-6532
Trial acronym
ENHANCE- Enhanced treatment for headaches
Linked study record

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

 291627 0
Tension Type Headaches 291682 0
Condition category
Condition code
Other 292006 292006 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Neurological 292007 292007 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1: 12 weekly sessions of cognitive behavioural therapy, relaxation therapy and exposure as an opportunity to practice coping skills or when not possible the use of avoidance of triggers. Each 50 minute session will be administered in an individual format by a registered psychologist.

Intervention 2: 12 weekly sessions of cognitive behavioural therapy, relaxation techniques including components on the avoidance of triggers. Each 50 minute session will be administered in an individual format by a registered psychologist.
Intervention code [1] 289176 0
Treatment: Other
Intervention code [2] 289213 0
Behaviour
Comparator / control treatment
Wait list Control no treatment. The wait list control group will be offered treatment following the post assessment period (12 weeks of treatment and 4 week followup). The wait list control group will be offered either treatment 1 (learning to cope with triggers) or treatment 2 (Avoidance of triggers). Treatment type will be according to the participants preference.
Control group
Active

Outcomes
Primary outcome [1] 291897 0
Self-monitoring of daily headache activity using a headache diary
Timepoint [1] 291897 0
The diaries will be assessed at baseline (for 4 weeks prior to commencement of treatment), throughout treatment, immediately post treatment (for 4 weeks), four and 12 month follow-up (for 4 weeks).
“Throughout treatment” means monitoring this on a daily basis over the 12 weeks of treatment.
Primary outcome [2] 291898 0
Self-monitoring of daily medication use using a daily headache diary
Timepoint [2] 291898 0
The diaries will be assessed at baseline (for 4 weeks prior to commencement of treatment), throughout treatment, immediately post treatment (for 4 weeks), four and 12 month follow-up (for 4 weeks).
“Throughout treatment” means monitoring this on a daily basis over the 12 weeks of treatment.
Secondary outcome [1] 307762 0
Headache Disability Inventory (HDI)
Timepoint [1] 307762 0
Measurement time points: baseline, post treatment, four and 12 month follow-up
Secondary outcome [2] 307763 0
Headache Triggers Avoidance Questionnaire (HTAQ).

Timepoint [2] 307763 0
Measurement time points: baseline, post treatment, four and 12 month follow-up
Secondary outcome [3] 307764 0
The Headache Management Self-Efficacy Scale (HMSESv2 ).
Timepoint [3] 307764 0
Measurement time points: baseline, post treatment, four and 12 month follow-up
Secondary outcome [4] 307765 0
The Headache-Specific Locus of Control (HSLC)
Timepoint [4] 307765 0
Measurement time points: baseline, post treatment, four and 12 month follow-up
Secondary outcome [5] 307766 0
Coping Strategies Inventory (CSI)
Timepoint [5] 307766 0
Measurement time points: baseline, post treatment, four and 12 month follow-up
Secondary outcome [6] 307767 0
Short-Form Health Survey version 2 (SF-36v2).
Timepoint [6] 307767 0
Measurement time points: baseline, post treatment, four and 12 month follow-up

Eligibility
Key inclusion criteria
i) Diagnosed as either ‘migraine without aura’, ‘typical aura with migraine headache’, ‘chronic migraine’, ‘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 six months
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosed as ‘medication overuse headache’; (ii) headaches present continuously; (iii) recent changes in prophylactic medication (study requires that medication has been stable for previous month) (iv) pregnant, planning pregnancy during trial period or lactating iv) 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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The design of the proposed study will focus on the interaction test of a mixed factorial design. Data will be tested for assumptions underlying both univariate and multivariate parametric analysis.
The power analysis is based primarily on the effect sizes generated in previous clinical trials of f = 0.33 to 0.42. Based on previous results an effect size of f =.25 (commonly accepted convention for a medium effect) can be confidently predicted. Power analysis using a G-Power software package indicates that for a three-group mixed factorial design with 40 participants per group and alpha = .05, moderate effects (f =.25) would be reliably identified with power .93 and a large effect (f = 0.4)would have an almost certain probability of being reliably identified.
Any missing data will be considered on an ‘intention-to-treat’ basis and fully analysed for the presence of MAR, MCAR, and NMAR patterns. In addition to exploratory descriptive and correlational analyses, group by phase factorial ANOVAs using a Linear Mixed Models approach will be the main method of analysis for assessing treatment outcome. These will be supplemented by analyses of simple main effects and trend analysis (ie. analysis of orthogonal polynomials) to examine the pattern of change over time for the experimental group. A linear mixed modelling approach has been chosen in order to permit: flexible structuring of the repeated covariance associated with the phase effect; more options for dealing with missing values; the analysis of individual change via growth curves; and options for analysing multi-level models, should they be theoretically or clinically relevant. For all inferential tests, measure of effect size (ie. either d or eta 2) will be calculated, including confidence intervals around those measures. A range of clinical significance measures will also be considered. Finally, regression analyses will be used to examine predictors of response to treatment, and the approach of Preacher and Hayes (2008) to moderation analysis will be used to examine the client-treatment matching hypotheses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/05/2014
Actual
Date of last participant enrolment
Anticipated
30/01/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 8011 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 289076 0
Government body
Name [1] 289076 0
NHMRC
National Health and Medical Research Council
APP1046745
Country [1] 289076 0
Australia
Primary sponsor type
Individual
Name
Professor Paul Martin (Principal Investigator)
Address
Department of Applied Psychology
Mt Gravatt Campus, Griffith University
176 Messines Ridge Road
Mt Gravatt, QLD 4122
Country
Australia
Secondary sponsor category [1] 287737 0
Individual
Name [1] 287737 0
Professor Peter Goadsby (Co-Investigator)
Address [1] 287737 0
Professor of Neurology
Director, NIHR-Wellcome Trust Clinical Research Facility
Imperial College London, South Kensington Campus, London SW7 2AZ
Country [1] 287737 0
United Kingdom
Secondary sponsor category [2] 287738 0
Individual
Name [2] 287738 0
Professor Simon Broadley (Co-Investigator)
Address [2] 287738 0
School: Medicine Gold Coast Campus
Griffith Health Centre
Cnr of Olsen Ave and Parklands Drive
Southport, QLD 4215
Country [2] 287738 0
Australia
Secondary sponsor category [3] 287739 0
Individual
Name [3] 287739 0
Professor Colin Macleod (Co-Investigator)
Address [3] 287739 0
School of Psychology
University of Western Australia
35 Stirling Highway
Crawley, WA 6009
Country [3] 287739 0
Australia
Secondary sponsor category [4] 287740 0
Individual
Name [4] 287740 0
Associate Professor John Reese (Co-Investigator)
Address [4] 287740 0
Division of Psychology
RMIT University
Bundoora Campus
PO Box 71 Bundoora, Vic 3083
Country [4] 287740 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290869 0
Ethics Approval Griffith University
Ethics committee address [1] 290869 0
Manager, Research Ethics
Office for Research
Gold Coast campus
Room 4.25, The Learning Commons Building (G11)
Griffith University
Parklands Drive, Southport QLD 4215
Ethics committee country [1] 290869 0
Australia
Date submitted for ethics approval [1] 290869 0
Approval date [1] 290869 0
01/10/2013
Ethics approval number [1] 290869 0
PSY/31/13HREC
Ethics committee name [2] 292001 0
Queensland Health Ethics Committee
Ethics committee address [2] 292001 0
Gold Coast University Hospital Ethics Committee
Gold Coast University Hospital and Health Service
1 Hospital Boulevard Southport
QLD 4215
Ethics committee country [2] 292001 0
Australia
Date submitted for ethics approval [2] 292001 0
Approval date [2] 292001 0
01/07/2014
Ethics approval number [2] 292001 0
HREC/14/QGC/72

Summary
Brief summary
The aim of this research is to investigate a behavioural treatment for the management of headache triggers within a cognitive-behavioural therapy program. The research will compare two variations of trigger management, one being the traditional approach (avoidance of all triggers) and one being a variation of the traditional approach (learning to cope with triggers). The investigators hypothesise that the enhanced approach which assists individuals to manage triggers rather than simply avoid them will have more positive outcomes including reduced headache frequency, reduced use of pain medication and improved quality of life
Trial website
http://www.griffith.edu.au/health/enhanced-treatment-headaches
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47678 0
Prof Paul R Martin
Address 47678 0
School of Applied Psychology
Mt Gravatt Campus, Griffith University
176 Messines Ridge Road
Mt Gravatt, QLD 4122
Country 47678 0
Australia
Phone 47678 0
+61 7 3735 3322
Fax 47678 0
Email 47678 0
[email protected]
Contact person for public queries
Name 47679 0
Prof Paul R Martin
Address 47679 0
School of Applied Psychology
Mt Gravatt Campus, Griffith University
176 Messines Ridge Road
Mt Gravatt, QLD 4122
Country 47679 0
Australia
Phone 47679 0
+61 7 3735 3322
Fax 47679 0
Email 47679 0
[email protected]
Contact person for scientific queries
Name 47680 0
Prof Paul R Martin
Address 47680 0
School of Applied Psychology
Mt Gravatt Campus, Griffith University
176 Messines Ridge Road
Mt Gravatt, QLD 4122
Country 47680 0
Australia
Phone 47680 0
+61 7 3735 3322
Fax 47680 0
Email 47680 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
SourceTitleYear of PublicationDOI
EmbaseEnhancing cognitive-behavioural therapy for recurrent headache: Design of a randomised controlled trial.2014https://dx.doi.org/10.1186/s12883-014-0233-9
N.B. These documents automatically identified may not have been verified by the study sponsor.