ANZCTR - Registration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Chronic Whiplash Associated Disorders

Condition category

Condition code

Musculoskeletal

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]

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]

Neck Disability Index (NDI)

Timepoint [1]

at 10 weeks, 16 weeks, 6 months and 12 months post randomisation.

Secondary outcome [1]

Average pain intensity over last week (0-10 scale)

Timepoint [1]

at 10 weeks, 16 weeks, 6 months and 12 months after randomization

Secondary outcome [2]

Average pain intensity over last 24 hours (0-10 scale)

Timepoint [2]

at 10 weeks, 16 weeks, 6 months and 12 months after randomization

Secondary outcome [3]

Patient’s global impression of recovery (-5 to +5 scale)

Timepoint [3]

at 10 weeks, 16 weeks, 6 months and 12 months after randomization

Secondary outcome [4]

Clinician administered PTSD scale (CAPS)

Timepoint [4]

at 10 weeks, 16 weeks, 6 months and 12 months after randomization

Secondary outcome [5]

The PTSD Checklist-5 (PCL-5)

Timepoint [5]

at 10 weeks, 16 weeks, 6 months and 12 months after randomization

Secondary outcome [6]

The Depression, Anxiety, Stress Scale-21 (DASS-21)

Timepoint [6]

at 10 weeks, 16 weeks, 6 months and 12 months after randomization

Secondary outcome [7]

Generic measure of health status (SF-36)

Timepoint [7]

at 10 weeks, 16 weeks, 6 months and 12 months after randomization

Secondary outcome [8]

Patient-generated measure of disability (Patient-Specific Functional Scale

Timepoint [8]

at 10 weeks, 16 weeks, 6 months and 12 months after randomization

Secondary outcome [9]

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]

10 weeks, 16 weeks, 6 months and 12 months after randomization

Secondary outcome [10]

Pain Catastrophizing Scale (PCS)

Timepoint [10]

at 10 weeks, 16 weeks, 6 months and 12 months after randomization

Secondary outcome [11]

Pain Self Efficacy Questionnaire (PSEQ)

Timepoint [11]

at 10 weeks, 16 weeks, 6 months and 12 months after randomization

Secondary outcome [12]

Tampa Scale of Kinesiophobia (TSK)

Timepoint [12]

at 10 weeks, 16 weeks, 6 months and 12 months after randomization

Secondary outcome [13]

Physical measures: Cold pain thresholds measured over the cervical spine at C5/6. These will be measured using the Somedic Thermotest system.

Timepoint [13]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/06/2015

Actual

Date of last participant enrolment

Anticipated

5/12/2016

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

110

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4222 - Griffith University

Recruitment postcode(s) [2]

4072 - University Of Queensland

Recruitment outside Australia

Country [1]

Denmark

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1
16 Marcus Clarke Street
Canberra
ACT 2601

Country [1]

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]

University

Name [1]

Centre of National Research on Disability and Rehabilitation Medicine

Address [1]

The University of Queensland
Level 7 UQ Oral Health Centre
Herston QLD 4029

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Human Research Ethics Committee

Ethics committee address [1]

Office for Research
Bray Centre, Nathan Campus
Griffith University, Qld

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

14/05/2014

Ethics approval number [1]

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

Prof Michele Sterling

Address

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

Australia

Phone

+617 5552 9771

Fax

[email protected]

Contact person for public queries

Name

Prof Michele Sterling

Address

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

Australia

Phone

+617 5552 9771

Fax

[email protected]

Contact person for scientific queries

Name

Prof Michele Sterling

Address

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

Australia

Phone

+617 5552 9771

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23337	Study protocol	J Physiother. 2015 Oct;61(4):218. doi: 10.1016/j.jphys.2015.07.003

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4871	Study results article	Yes	https://doi.org/dx.doi.org/10.1097/j.pain.0000000000002117		Trauma-focused cognitive behavioural therapy and exercise for chronic whiplash with comorbid posttraumatic stress disorder_ a randomised controlled trial.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Trauma-focused cognitive behaviour therapy and exercise for chronic whiplash: protocol of a randomised, controlled trial.	2015	https://dx.doi.org/10.1016/j.jphys.2015.07.003

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically