Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000227796
Ethics application status
Approved
Date submitted
24/01/2022
Date registered
8/02/2022
Date last updated
1/06/2024
Date data sharing statement initially provided
8/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study of Cognitive Behavioural Therapy for Migraine in Multiple Sclerosis
Scientific title
Evaluation of a non-pharmacological approach: Pilot Randomised Controlled Trial of Cognitive Behavioural Therapy for Migraine in Multiple Sclerosis
Secondary ID [1] 306237 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis 324963 0
Migraine 324964 0
Condition category
Condition code
Neurological 322397 322397 0 0
Multiple sclerosis
Neurological 322398 322398 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Name: A Pilot Study of Cognitive Behavioural Therapy for Migraine in Multiple Sclerosis
A brief cognitive behavioural therapy program will be conducted in five sessions across 5 weeks with one-hour weekly sessions and a follow-up phone call 4-weeks later. Therapy sessions will include education about migraine, relaxation strategies, ways of dealing with negative thoughts and emotions, and compensatory strategies to manage cognitive difficulties (e.g., concentration and memory). The study will be conducted entirely on telehealth via internet, so participants can attend from home. Sessions will be on a one-on-one basis, with a neuropsychology registrar.
Prior to three sessions, a series of questionnaires on migraine, day-to-day functioning and wellbeing will be sent to monitor progress, via an online link.
Intervention code [1] 322660 0
Treatment: Other
Comparator / control treatment
The study will use a waitlist control . This group will complete the same series of questionnaires as the treatment group, at Week 1, 5, and 9. CBT will then be offered from week 9 for the waitlist group.
Participants will have a 2 in 3 chance of being allocated to the treatment group and 1 in 3 chance of being allocated to the waitlist control group.
Control group
Active

Outcomes
Primary outcome [1] 330195 0
Change in migraine frequency, intensity and duration (measured using a headache diary).
Timepoint [1] 330195 0
Week 1 (before the treatment), Week 5 (at the end of treatment) (primary timepoint), and at 4-week follow-up.
Secondary outcome [1] 405260 0
Changes in mood (measured on the Generalised Anxiety Disorder-7 scale and Beck Depression Inventory II)
Timepoint [1] 405260 0
Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4-week follow-up.
Secondary outcome [2] 405261 0
Changes in fatigue measured on the Modified Fatigue Impact Scale.
Timepoint [2] 405261 0
Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4-week follow-up.
Secondary outcome [3] 405262 0
Changes in cognitive functioning (measured on validated neuropsychological tests).
Timepoint [3] 405262 0
Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4-week follow-up.
Secondary outcome [4] 405263 0
Changes in quality of life will be measured using the Multiple Sclerosis Quality of Life-54 scale.
Timepoint [4] 405263 0
Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4-week follow-up.
Secondary outcome [5] 405264 0
Changes in psychological processes such as self-efficacy will be measured using the Headache Management Self-Efficacy scale.
Timepoint [5] 405264 0
Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4-week follow-up.
Secondary outcome [6] 405654 0
The impact of migraine on daily life (measured on the Migraine Disability Assessment Test and Headache Impact Test).
Timepoint [6] 405654 0
Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4-week follow-up.
Secondary outcome [7] 405656 0
Daily functioning such as work productivity and social activities will be measured using the Work Productivity and Activity Impairment questionnaire.
Timepoint [7] 405656 0
Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4-week follow-up.
Secondary outcome [8] 405657 0
Locus of control will be evaluated using the multidimensional Health Locus of Control scale).
Timepoint [8] 405657 0
Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4-week follow-up.
Secondary outcome [9] 405658 0
Treatment change expectancy will be measured using the Stanford Expectations of Treatment scale,
Timepoint [9] 405658 0
Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4-week follow-up.
Secondary outcome [10] 405659 0
The participants' level of pain-specific catastrophising will be assessed using the Pain catastrophising scale,
Timepoint [10] 405659 0
Week 1 (before the treatment), Week 5 (at the end of treatment), and at 4-week follow-up.

Eligibility
Key inclusion criteria
1. Diagnosis of migraine
2. Diagnosis of relapsing-remitting multiple sclerosis
3. English fluency
4. Medicare eligibility
5. Internet access
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently receiving psychological therapy or seeing a psychologist
2. Other diagnosed neurological disorder (e.g., traumatic brain injury, stroke, epilepsy)
3. Current severe psychiatric symptoms (e.g., psychosis, severe depression)

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)
Allocation will be concealed, using sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be used, with three participants in each block, to ensure close balance of the numbers in each group at any time during the trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All participants receive the same intervention, but the treatment group receives this over the course of the study (Week 1-9) while the waitlist group receives it after their study assessments (after Week 9).
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Given that the current study is a pilot trial, it will be underpowered to detect treatment effects and does not endeavour to do so. As there is no published data on the effect sizes found in CBT studies for migraine, a power calculation is not applicable. In addition, formal power calculations were not completed as the estimates from this pilot study will be used to inform adequate sample size in a large-scale RCT. The study aims to have 20 participants complete therapy and 10 participants in the waitlist control. This total sample of 30 has been recommended for pilot studies by Lancaster, Dodd and Williamson (2004) in estimating standard deviations and attrition rates.

Statistical analyses will be dependent on the final sample size and determined in consultation with a statistician. The means and standard deviations of the outcome measures will be calculated separately for the treatment and control groups, to inform a sample size calculation for the later large-scale RCT. Differences between the groups at baseline will be examined with t-tests for continuous data and chi-squared tests for dichotomous variables.

To assess the feasibility of the project, the proportion of participants who are recruited, consented, complete CBT, and complete the 4-week follow-up session will be calculated. Participants’ feedback on the program will be qualitatively assessed. To preliminarily assess key indicators of symptom change, reliable change indices may be used to determine the number of participants in each group with statistically reliable change by the 9-week endpoint (Jacobson & Truax, 1991).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/05/2022
Actual
7/07/2022
Date of last participant enrolment
Anticipated
3/05/2024
Actual
30/10/2023
Date of last data collection
Anticipated
19/07/2024
Actual
6/03/2024
Sample size
Target
30
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310584 0
Hospital
Name [1] 310584 0
Alfred Health
Country [1] 310584 0
Australia
Funding source category [2] 310663 0
University
Name [2] 310663 0
Monash University
Country [2] 310663 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Level 6, Alfred Centre 99 Commercial Road, Melbourne 3004 VIC
Country
Australia
Secondary sponsor category [1] 311799 0
None
Name [1] 311799 0
Address [1] 311799 0
Country [1] 311799 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310190 0
Alfred Human Research Ethics Committee
Ethics committee address [1] 310190 0
Ethics committee country [1] 310190 0
Australia
Date submitted for ethics approval [1] 310190 0
17/01/2022
Approval date [1] 310190 0
12/05/2022
Ethics approval number [1] 310190 0
HREC Reference 82110

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

Contacts
Principal investigator
Name 116810 0
Dr Elspeth Hutton
Address 116810 0
Level 6, 99 Commercial Road, The Alfred Centre,
Melbourne 3004, VIC Australia
Country 116810 0
Australia
Phone 116810 0
+61 03 99030781
Fax 116810 0
Email 116810 0
[email protected]
Contact person for public queries
Name 116811 0
Pavika Thevar
Address 116811 0
Level 6, 99 Commercial Road, The Alfred Centre,
Melbourne 3004, VIC Australia
Country 116811 0
Australia
Phone 116811 0
+61 03 99030894
Fax 116811 0
Email 116811 0
[email protected]
Contact person for scientific queries
Name 116812 0
Elspeth Hutton
Address 116812 0
Level 6, 99 Commercial Road, The Alfred Centre,
Melbourne 3004, VIC Australia
Country 116812 0
Australia
Phone 116812 0
+61 03 99030781
Fax 116812 0
Email 116812 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The project aims to establish the acceptability and feasibility of the CBT program for a later larger-scale RCT, such that sharing individual data is not necessary or appropriate.


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.