Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000164392
Ethics application status
Approved
Date submitted
30/03/2008
Date registered
4/04/2008
Date last updated
9/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive behaviour therapy for co-morbid chronic headache and depression
Scientific title
Evaluation of Cognitive behaviour therapy for reducing headaches and decreasing depression.
Secondary ID [1] 285310 0
Nil known
Universal Trial Number (UTN)
Trial acronym
HeaD-ON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic headache 2974 0
Major depressive disorder 2975 0
Condition category
Condition code
Neurological 3116 3116 0 0
Other neurological disorders
Mental Health 3117 3117 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves 12 50-minute sessions and includes: education about headaches and depression; relaxation training; scheduling pleasant activities; social skills training; training to challenge dysfunctional thoughts and underlying beliefs; problem solving training; identifying and managing headache triggers; training in pain management techniques; lifestyle management; and relapse prevention training.
Intervention code [1] 2712 0
Behaviour
Comparator / control treatment
Routine primary care - participants in this group will be case managed by their GPs as they would in the absence of the study, with small variations. No attempt will be made to restrict GPs in terms of prescribed medication but records of prescribed medication will be maintained.
Control group
Active

Outcomes
Primary outcome [1] 4005 0
Headache activity - an index determined by headache frequency, severity and duration
Timepoint [1] 4005 0
Post-treatment and 4-month follow-up
Primary outcome [2] 4006 0
Depression - level of severity - using Beck Depression Inventory
Timepoint [2] 4006 0
Post-treatment and 4-month follow-up
Secondary outcome [1] 6743 0
Anxiety - level of severity - using Beck Anxiety Inventory
Timepoint [1] 6743 0
Post-treatment and 4-month follow-up
Secondary outcome [2] 6744 0
Quality of life - using the complementary SF-36 from the Medical Outcomes Study, and the Australian Quality of Life instrument.
Timepoint [2] 6744 0
Post-treatment and 4-month follow-up

Eligibility
Key inclusion criteria
Diagnosed as tension-type headache or migraine, minimum of 6 headaches per month, minimum chronicity of 12 months and pattern stable over 6 months, and diagnosed as major depressive disorder.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major psychiatric disorders other than anxiety disorders, factors interfering with giving informed consent or benefiting from treatment, and medical conditions with over riding treatment requirements.

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)
Subjects will be recruited through General Practitioners. After individuals have consented to taking part in the study and been assessed as meeting the eligibility criteria for the study, they will be referred to an Associate Investigator for allocation to the treatment conditions. This Associate Investigator will not meet any of the participants or have any information about them, as his role will be restricted to the allocation to treatment conditions and subsequent statistical analysis of data.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated sequence will be used following the CONSORT guidelines. A stratified randomisation procedure will be used to allocate subjects to the two conditions, with stratification based on diagnosis (migraine versus tension-type headache).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2008
Actual
28/07/2008
Date of last participant enrolment
Anticipated
Actual
27/01/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 3238 0
Government body
Name [1] 3238 0
beyondblue: the national depression initiative
Country [1] 3238 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton
Victoria 3800
Country
Australia
Secondary sponsor category [1] 2896 0
Hospital
Name [1] 2896 0
Southern Health
Address [1] 2896 0
Monash Medical Centre
246 Clayton Road
Clayton, Victoria 3168
Country [1] 2896 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5219 0
Southern Health
Ethics committee address [1] 5219 0
Monash Medical Centre, Research Directorate, Level 4, Main Block, 246 Clayton Road, Clayton, Victoria 3168
Ethics committee country [1] 5219 0
Australia
Date submitted for ethics approval [1] 5219 0
22/04/2008
Approval date [1] 5219 0
21/07/2008
Ethics approval number [1] 5219 0
08062A

Summary
Brief summary
Numerous studies have demonstrated comorbidity between migraine and tension-type headache on the one hand, and depression on the other. It is not clear whether this reflects a causal relationship between headaches and depression or common predispositional factors. Presence of depression is a negative prognostic indicator for behavioral treatment of headaches. Despite the recognised comorbidity, there is limited research literature evaluating interventions designed for comorbid headaches and depression. Sixty six participants (49 female, 17 male) suffering from migraine and/or tension-type headache and major depressive disorder were randomly allocated to a Cognitive Behavior Therapy program, or a control group (Routine Primary Care). The treatment program involved 12 weekly 50-minute sessions administered by clinical psychologists. Participants in the treatment and control groups significantly differed from baseline to post-treatment on measures of headaches, depression, anxiety, and quality of life. Improvements achieved with treatment were maintained at four month follow-up. Changes in headaches and depression were not significantly correlated suggesting that the relationship between them may not be causal. Comorbid anxiety disorders were not a predictor of response to treatment, and the only significant predictor was gender (men improved more than women). The new integrated treatment program appears promising and worthy of further investigation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28475 0
Prof Paul R Martin
Address 28475 0
School of Applied Psychology, Griffith University, Mt Gravatt Campus, 176 Messines Ridge Road, Mt Gravatt, Queensland 4122.
Country 28475 0
Australia
Phone 28475 0
+61 07 3735 3322
Fax 28475 0
+61 07 3735 3388
Email 28475 0
[email protected]
Contact person for public queries
Name 11632 0
Prof Paul R Martin
Address 11632 0
School of Applied Psychology, Griffith University, Mt Gravatt Campus, 176 Messines Ridge Road, Mt Gravatt, Queensland 4122.
Country 11632 0
Australia
Phone 11632 0
+61 07 3735 3322
Fax 11632 0
+61 07 3735 3388
Email 11632 0
[email protected]
Contact person for scientific queries
Name 2560 0
Prof Paul Martin
Address 2560 0
School of Applied Psychology, Griffith University, Mt Gravatt Campus, 176 Messines Ridge Road, Mt Gravatt, Queensland 4122.
Country 2560 0
Australia
Phone 2560 0
+61 07 3735 3322
Fax 2560 0
+61 07 3735 3388
Email 2560 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
EmbaseCognitive behavior therapy for comorbid migraine and/or tension-type headache and major depressive disorder: An exploratory randomized controlled trial.2015https://dx.doi.org/10.1016/j.brat.2015.07.005
N.B. These documents automatically identified may not have been verified by the study sponsor.