Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000185864
Ethics application status
Approved
Date submitted
10/02/2012
Date registered
10/02/2012
Date last updated
27/06/2022
Date data sharing statement initially provided
15/02/2022
Date results information initially provided
15/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Combining Cognitive Behaviour Therapy with either Exercise or Stretching for Adults with Posttraumatic Stress Disorder
Scientific title
Randomised Controlled Trial of Combining Cognitive Behaviour Therapy with either Exercise or Stretching for Adults with Posttraumatic Stress Disorder
Secondary ID [1] 279913 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder 285823 0
Condition category
Condition code
Mental Health 286003 286003 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this trial. Arm 1: CBT/Exercise. Arm 2: CBT/Stretching. Therapy is administered once-weekly over 11 weeks on an individual 90 minute basis. CBT includes education about PTSD, cognitive restructuring of erroneous beliefs about the trauma experience, and exposure to memories of the trauma and to avoided situation. Exercise involves 10 minutes of aerobic exercise via a stepping activity, with the target heart rate (HR) being [60-80% / 100 x (Max HR – Resting HR) + Resting HR]. In the CBT/Exercise condition this exercise will occur immediately at the conclusion of the CBT session. The duration of the study for any participant will conclude after a 6-month follow-up assessment, resulting in participation duration of 9 months.
Intervention code [1] 284241 0
Behaviour
Intervention code [2] 284245 0
Treatment: Other
Comparator / control treatment
The CBT/Stretching condition is identical to the CBT/Exercise except that participants complete 10 minutes of stretching immediately following the CBT sessions. CBT includes education about PTSD, cognitive restructuring of erroneous beliefs about the trauma experience, and exposure to memories of the trauma and to avoided situation. Stretching will comprise simple body stretches for a period of 10 minutes. Therapy is administered once-weekly over 11 weeks on an individual 90 minute basis. The duration of the study for any participant will conclude after a 6-month follow-up assessment, resulting in participation duration of 9 months.
Control group
Active

Outcomes
Primary outcome [1] 286493 0
Posttraumatic stress disorder, as measured by the Clinician Administered PTSD Scale.
Timepoint [1] 286493 0
Pretreatment, posttreatment, 6-Month Follow-up
Secondary outcome [1] 296019 0
Depression, as measured by the Beck Depression Inventory.
Timepoint [1] 296019 0
Pretreatment, posttreatment, 6-Month Follow-up
Secondary outcome [2] 406318 0
Cognitive appraisals as measured by the Posttraumatic Cognitions Inventory
Timepoint [2] 406318 0
Pretreatment, posttreatment, and 6-month follow-up
Secondary outcome [3] 406319 0
Anxiety as measured by the Beck Anxiety Inventory.
Timepoint [3] 406319 0
Pretreatment, posttreatment, and 6-month follow-up.

Eligibility
Key inclusion criteria
Adults survivors of trauma who meet criteria for Postraumatic Stress Disorder
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe suicidal intent, psychotic, substance dependent, history of moderate or severe brain injury, or physical complaint that may be exacerbated by acute exercise.

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 will be treatment seeking adults who respond to advertising in Sydney, Australia. Participants will be randomly allocated according to a random numbers system administered by an individual who is independent of the study and who works at a site that is distant from the treatment centre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted by a process of minmization stratified on gender and severity of PTSD levels.
Masking / blinding
Blinded (masking 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
10/03/2012
Actual
12/12/2012
Date of last participant enrolment
Anticipated
Actual
25/07/2018
Date of last data collection
Anticipated
25/04/2022
Actual
5/04/2019
Sample size
Target
120
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21741 0
Westmead Hospital - Westmead

Funding & Sponsors
Funding source category [1] 284690 0
Government body
Name [1] 284690 0
Australian Research Council
Country [1] 284690 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Psychology, University of New South Wales, Anzac Parade, Kensington, Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 283590 0
Hospital
Name [1] 283590 0
Westmead Hospital
Address [1] 283590 0
O'Brien's Road, Westmead, NSW, 2145
Country [1] 283590 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286688 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 286688 0
Westmead Hospital, Hawkesbury Rd, Westmead, NSW, 2145
Ethics committee country [1] 286688 0
Australia
Date submitted for ethics approval [1] 286688 0
12/02/2012
Approval date [1] 286688 0
09/10/2012
Ethics approval number [1] 286688 0
HREC/12/WMEAD/63

Summary
Brief summary
The rationale of the study is to evaluate the roles of exercise and stretching in enhancing the effectiveness of Cognitive Behaviour Therapy in reducing the symptoms of posttraumatic stress disorder. This study compares the relative effectiveness of (a) Cognitive Behaviour Therapy Combined with Exercise, and (b) Cognitive Behaviour Therapy Combined with Stretching, in reducing posttraumatic stress disorder symptoms. It is hypothesised that whereas both conditions will lead to symptom reduction, Cognitive Behaviour Therapy Combined with Exercise will lead to greater symptom reduction than either Cognitive Behaviour Therapy Combined with Stretching.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3204 3204 0 0
http://www.anzctr.org.au/AnzctrAttachments/362081-ptsd exercise ssa approval letter .pdf (Ethics approval)
Attachments [2] 3205 3205 0 0
http://www.anzctr.org.au/AnzctrAttachments/362081(v08-06-2018-20-28-42)-ptsd exercise ssa approval letter .pdf (Ethics approval)
Attachments [3] 3206 3206 0 0
http://www.anzctr.org.au/AnzctrAttachments/362081(v08-06-2018-20-28-43)-ptsd exercise ssa approval letter .pdf (Ethics approval)

Contacts
Principal investigator
Name 33759 0
Prof Richard Bryant
Address 33759 0
School of Psychology, University of New South Wales, Sydney, NSW, 2052
Country 33759 0
Australia
Phone 33759 0
+61293853640
Fax 33759 0
Email 33759 0
[email protected]
Contact person for public queries
Name 17006 0
Prof Professor Richard Bryant
Address 17006 0
School of Psychology
University of New South Wales
Sydney, NSW, 2052
Country 17006 0
Australia
Phone 17006 0
61-2-93853640
Fax 17006 0
61-2-93853641
Email 17006 0
[email protected]
Contact person for scientific queries
Name 7934 0
Prof Professor Richard Bryant
Address 7934 0
School of Psychology
University of New South Wales
Sydney, NSW, 2052
Country 7934 0
Australia
Phone 7934 0
61-2-93853640
Fax 7934 0
61-2-93853641
Email 7934 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data pertaining to treatment outcomes
When will data be available (start and end dates)?
After all primary data analyses completed. Data available for IPD from 01/12/22. No end data determined.
Available to whom?
All researchers requesting these data
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Emailing Richard Bryant ([email protected])


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
EmbaseAugmenting trauma-focused psychotherapy for post-traumatic stress disorder with brief aerobic exercise in Australia: a randomised clinical trial.2023https://dx.doi.org/10.1016/S2215-0366%2822%2900368-6
EmbaseNeural activity during response inhibition associated with improvement of dysphoric symptoms of PTSD after trauma-focused psychotherapy-an EEG-fMRI study.2021https://dx.doi.org/10.1038/s41398-021-01340-8
N.B. These documents automatically identified may not have been verified by the study sponsor.