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Trial registered on ANZCTR


Registration number
ACTRN12615000547549
Ethics application status
Approved
Date submitted
4/05/2015
Date registered
28/05/2015
Date last updated
28/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Trauma-Focused Cognitive Behavioural Therapy (CBT) and Exercise for Chronic Whiplash
Scientific title
In individuals with chronic whiplash, is exercise and trauma-focused cognitive behavioural therapy more effective than exercise and supported counselling on pain related disability levels.
Secondary ID [1] 284730 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Whiplash Associated Disorders 292082 0
Condition category
Condition code
Musculoskeletal 292422 292422 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention arm of this study will participate in 10 weeks of trauma-focused cognitive behaviour therapy (CBT) followed by a 6 week physiotherapy exercise program.

CBT: A psychological intervention that targets PTSD symptoms will be delivered first. Treatment will consist of 10 weekly 60-90 minute sessions of individually delivered trauma-focused CBT based on the Australian Guidelines for the treatment of Adults with Acute Stress Disorder and PTSD. Session one will focus on providing psychoeducation regarding the common symptoms of PTSD, maintaining factors and providing a rationale for various treatment components. Sessions two and three will continue to develop patient’s knowledge of PTSD symptoms and teach anxiety management strategies including deep breathing and progressive muscle relaxation. Cognitive restructuring which involves challenging unhelpful and irrational thoughts and beliefs will commence in session three and continue throughout treatment. Sessions four to ten will focus on exposure therapy including imaginal exposure and graded in-vivo exposure. Relapse prevention will also be included in the final session. Specific treatment protocol have been adapted from a detailed manual of individual trauma-focused CBT (see Bryant & Harvey, 2000 for further details) and a checklist for each session will be used to ensure the consistency and integrity of the intervention. Treatment will only be delivered by registered psychologists with postgraduate clinical training and experience delivering trauma-focused CBT interventions

Exercise: The 6-week exercise program will be carried out under supervision from the physiotherapist (2 sessions in the first and second weeks; 2 sessions in the third and fourth weeks; and 1 session in the fifth and sixth weeks) and will comprise specific exercises to improve the movement and control of the neck and shoulder girdles as well as proprioceptive and co-ordination exercises. The exercises will be tailored by the physiotherapist for each individual participant. Participants will also perform the exercises at home, once /day. The sessions with the physiotherapist will be up to 45 minutes in duration and the home exercises up to 20 minutes. A log book will be completed by participants to record compliance with the exercises. At the same time, the physiotherapist will guide the subject’s return to normal activities. Prof Michele Sterling (the chief investigator) will audit the physiotherapy sessions twice during the intervention to check for adherence. Principles of cognitive-behavioural therapy will be used by the physiotherapists in their training and supervisory roles for all exercises. The cognitive behavioural therapy principles include the encouragement of skill acquisition by modelling, setting progressive goals, self-monitoring of progress, and positive reinforcement of progress. Self-reliance will be fostered by encouraging subjects to engage in problem-solving to deal with difficulties rather than seeking reassurance and advice, by encouraging relevant and realistic activity goals, and by encouraging self-reinforcement. Daily physical activity at home will be encouraged and monitored using a diary. Written and illustrated exercise instructions will be provided.
Intervention code [1] 289513 0
Rehabilitation
Comparator / control treatment
Participants randomised to the control arm of this study will participate in 10 weeks of supported therapy followed by the same 6 week exercise program. These will comprise one 60 minute session once per week and will be delivered by a clinical psychologist

Supported Therapy: The first session will involve education about trauma and an explanation of the nature of supportive therapy. The following sessions will include general problem-solving skills and the provision of an unconditionally supportive role for the therapist. Homework involved diary keeping of current problems and mood states. Supportive therapy will specifically avoid exposure, cognitive restructuring or anxiety management techniques.

Exercise: The 6-week exercise program will be carried out under supervision from the physiotherapist (2 sessions in the first and second weeks; 2 sessions in the third and fourth weeks; and 1 session in the fifth and sixth weeks) and will comprise specific exercises to improve the movement and control of the neck and shoulder girdles as well as proprioceptive and co-ordination exercises. The exercises will be tailored by the physiotherapist for each individual participant. Participants will also perform the exercises at home, once /day. A log book will be completed by participants to record compliance with the exercises. At the same time, the physiotherapist will guide the subject’s return to normal activities. Prof Michele Sterling (the chief investigator) will audit the physiotherapy sessions twice during the intervention to check for adherence. Principles of cognitive-behavioural therapy will be used by the physiotherapists in their training and supervisory roles for all exercises. The cognitive behavioural therapy principles include the encouragement of skill acquisition by modelling, setting progressive goals, self-monitoring of progress, and positive reinforcement of progress. Self-reliance will be fostered by encouraging subjects to engage in problem-solving to deal with difficulties rather than seeking reassurance and advice, by encouraging relevant and realistic activity goals, and by encouraging self-reinforcement. Daily physical activity at home will be encouraged and monitored using a diary. Written and illustrated exercise instructions will be provided.
Control group
Active

Outcomes
Primary outcome [1] 292285 0
Neck Disability Index (NDI)
Timepoint [1] 292285 0
at 10 weeks, 16 weeks, 6 months and 12 months post randomisation.
Secondary outcome [1] 308621 0
Average pain intensity over last week (0-10 scale)
Timepoint [1] 308621 0
at 10 weeks, 16 weeks, 6 months and 12 months after randomization
Secondary outcome [2] 308622 0
Average pain intensity over last 24 hours (0-10 scale)
Timepoint [2] 308622 0
at 10 weeks, 16 weeks, 6 months and 12 months after randomization
Secondary outcome [3] 308623 0
Patient’s global impression of recovery (-5 to +5 scale)
Timepoint [3] 308623 0
at 10 weeks, 16 weeks, 6 months and 12 months after randomization
Secondary outcome [4] 308624 0
Clinician administered PTSD scale (CAPS)
Timepoint [4] 308624 0
at 10 weeks, 16 weeks, 6 months and 12 months after randomization
Secondary outcome [5] 308625 0
The PTSD Checklist-5 (PCL-5)
Timepoint [5] 308625 0
at 10 weeks, 16 weeks, 6 months and 12 months after randomization
Secondary outcome [6] 308626 0
The Depression, Anxiety, Stress Scale-21 (DASS-21)
Timepoint [6] 308626 0
at 10 weeks, 16 weeks, 6 months and 12 months after randomization
Secondary outcome [7] 308628 0
Generic measure of health status (SF-36)
Timepoint [7] 308628 0
at 10 weeks, 16 weeks, 6 months and 12 months after randomization
Secondary outcome [8] 308629 0
Patient-generated measure of disability (Patient-Specific Functional Scale
Timepoint [8] 308629 0
at 10 weeks, 16 weeks, 6 months and 12 months after randomization
Secondary outcome [9] 308630 0
Physical measures: pressure pain thresholds measured over the cervical spine and upper limbs. These will be measured with a standard Somedic pressure alogmeter applied over C5/6 and over the median nerve at the elbow.
Timepoint [9] 308630 0
10 weeks, 16 weeks, 6 months and 12 months after randomization
Secondary outcome [10] 314083 0
Pain Catastrophizing Scale (PCS)
Timepoint [10] 314083 0
at 10 weeks, 16 weeks, 6 months and 12 months after randomization
Secondary outcome [11] 314084 0
Pain Self Efficacy Questionnaire (PSEQ)
Timepoint [11] 314084 0
at 10 weeks, 16 weeks, 6 months and 12 months after randomization
Secondary outcome [12] 314085 0
Tampa Scale of Kinesiophobia (TSK)
Timepoint [12] 314085 0
at 10 weeks, 16 weeks, 6 months and 12 months after randomization
Secondary outcome [13] 314764 0
Physical measures: Cold pain thresholds measured over the cervical spine at C5/6. These will be measured using the Somedic Thermotest system.
Timepoint [13] 314764 0
at 10 weeks, 16 weeks, 6 months and 12 months after randomization

Eligibility
Key inclusion criteria
1. people with persistent neck pain (greater than 3 months but less than 5 years duration) from a whiplash injury as a result of a motor vehicle accident (MVA) and
2. reporting at least moderate pain and disability (greater than or equal to 30% on the Neck Disability Index questionnaire) and
3. a Post Traumatic Stress Disorder (PTSD) diagnosis (DSM-5, APA, 2013) using the clinician administered PTSD scale-5 (CAPS-5)
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known or suspected serious spinal pathology (eg metastatic, inflammatory or infective diseases of the spine); Confirmed fracture or dislocation at the time of injury, nerve root compromise (at least 2 of the following signs; weakness/reflex changes/sensory loss associated with the same spinal nerve); spinal surgery in the last 12 months; or a history or current presentation of psychosis, bipolar disorder, organic brain disorder, severe depression or substance abuse.

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)
Participants who meet the inclusion criteria (NDI >30% and PTSD diagnosis) will be evaluated on all outcome measures, for baseline results. A research assistant who is blind to the results of outcome measures will then contact the study statistician and receive the group allocation for the individual participant. This same research assistant will arrange all appointment times with the treating practitioners and the blinded assessor for all outcome measures. Participants will be instructed not to reveal details about their treatment to the examiner in order to assist with blinding.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by the study biostatistician. Randomisation will be by computerised block randomisation. Consecutively numbered, sealed, opaque envelopes will be used to conceal randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All analyses will be conducted on an intention to treat basis. The primary and secondary outcomes measured at 10 weeks, 16 weeks, 6 months and 12 months will be analysed using linear mixed and logistic regression models that will include their respective baseline scores as a covariate, subjects as a random effect and treatment conditions as fixed factors. Diagnostics will be used to examine assumptions, including homogeneity of variances. Effect sizes will be calculated for all measures with an effect size of 0.2 considered small, 0.5 medium and 0.8 large. Alpha will be set at 0.05.
Sample size: We are interested in detecting a clinically important difference between the two interventions, given that baseline values for each group are statistically equivalent as a result of the randomisation. Based on a two-sided t-test a sample of 86 (43 per group) will provide 80% power to detect a significant difference at alpha 0.05 between the group means of 10 points on the 100 point NDI (assuming a SD of 16, based on our pilot data and data from recent trials ). Effects smaller than this are unlikely to be considered clinically worthwhile. Allowing for a 20% loss to follow up by 12 months, we would require 54 participants per treatment group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 8224 0
4222 - Griffith University
Recruitment postcode(s) [2] 8225 0
4072 - University Of Queensland
Recruitment outside Australia
Country [1] 6811 0
Denmark
State/province [1] 6811 0

Funding & Sponsors
Funding source category [1] 289348 0
Government body
Name [1] 289348 0
National Health and Medical Research Council
Address [1] 289348 0
Level 1
16 Marcus Clarke Street
Canberra
ACT 2601
Country [1] 289348 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Centre of Clinical Research Excellence in Road Traffic Injury Recovery
Menzies Health Institute QLD
Griffith University - Gold Coast Campus
G05_3.20
Parklands Dr
Southport QLD 4222
Country
Australia
Secondary sponsor category [1] 288032 0
University
Name [1] 288032 0
Centre of National Research on Disability and Rehabilitation Medicine
Address [1] 288032 0
The University of Queensland
Level 7 UQ Oral Health Centre
Herston QLD 4029
Country [1] 288032 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292770 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 292770 0
Office for Research
Bray Centre, Nathan Campus
Griffith University, Qld
Ethics committee country [1] 292770 0
Australia
Date submitted for ethics approval [1] 292770 0
Approval date [1] 292770 0
14/05/2014
Ethics approval number [1] 292770 0
AHS/15/14/HREC

Summary
Brief summary
The primary aim of this project is to investigate the effectiveness of combined trauma-focused CBT and exercise to decrease pain and disability of individuals with chronic whiplash and PTSD. The secondary aims are to investigate the effectiveness of combined trauma-focused CBT and exercise to decrease posttraumatic stress symptoms, anxiety and depression, and to investigate the effectiveness of trauma-focused CBT alone on posttraumatic stress symptoms and pain/disability.

For individuals with chronic whiplash and posttraumatic stress, it is hypothesised that:
1. Trauma-focused CBT followed by a physiotherapy exercise program will result in significantly greater improvements in pain and disability up to 12 months post treatment compared with supported counselling followed by a physiotherapy exercise program.
2. Trauma-focused CBT followed by a physiotherapy exercise program will result in significantly greater improvements in posttraumatic stress symptoms, anxiety and depression up to 12months post treatment compared with supported counselling and a physiotherapy exercise program.
3. An initial treatment of trauma-focused CBT will result in significantly greater improvements in pain/disability, posttraumatic stress symptoms, anxiety and depression immediately post-treatment compared with a supported counselling intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48926 0
Prof Michele Sterling
Address 48926 0
Centre of Clinical Research Excellence in Road Traffic Injury Recovery
Menzies Health Institute QLD
Griffith University - Gold Coast Campus
G05_3.20
Parklands Drive
Southport Qld 4222
Country 48926 0
Australia
Phone 48926 0
+617 5552 9771
Fax 48926 0
Email 48926 0
m.sterling@griffith.edu.au
Contact person for public queries
Name 48927 0
Prof Michele Sterling
Address 48927 0
Centre of Clinical Research Excellence in Road Traffic Injury Recovery
Menzies Health Institute QLD
Griffith University - Gold Coast Campus
G05_3.20
Parklands Drive
Southport Qld 4222
Country 48927 0
Australia
Phone 48927 0
+617 5552 9771
Fax 48927 0
Email 48927 0
m.sterling@griffith.edu.au
Contact person for scientific queries
Name 48928 0
Prof Michele Sterling
Address 48928 0
Centre of Clinical Research Excellence in Road Traffic Injury Recovery
Menzies Health Institute QLD
Griffith University - Gold Coast Campus
G05_3.20
Parklands Drive
Southport Qld 4222
Country 48928 0
Australia
Phone 48928 0
+617 5552 9771
Fax 48928 0
Email 48928 0
m.sterling@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
No Results