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Trial registered on ANZCTR


Registration number
ACTRN12612000185864
Ethics application status
Not yet submitted
Date submitted
10/02/2012
Date registered
10/02/2012
Date last updated
10/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Combining Cognitive Behaviour Therapy with either Exercise or Yoga for Adults with Posttraumatic Stress Disorder
Scientific title
Randomised Controlled Trial of Combining Cognitive Behaviour Therapy with either Exercise or Yoga 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 three arms to this trial. Arm 1: CBT/Exercise. Arm 2: CBT/Yoga. Arm 3: CBT/Delayed Exercise. Therapy is administered once-weekly over 9 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 exericse 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/Yoga 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. Yoga will comprise simple body stretches for a period of 10 minutes. Therapy is administered once-weekly over 9 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.

The CBT/Delayed Exercise condition is identical to the CBT/Exercise except that participants complete 10 minutes of exercise 1 day following the CBT sessions. Therapy is administered once-weekly over 9 weeks on an individual 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 invovles 10 minutes of aerobic exericse via a stepping activity. In the CBT/Delayed Exercise condition this exercise will occur 1 day after 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.
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

Eligibility
Key inclusion criteria
Adults survivors of trauma who meet criteria for Postraumatic Stress Disorder
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe suicidal intent, psychotic, substance dependent

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
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)

Funding & Sponsors
Funding source category [1] 284690 0
Government body
Name [1] 284690 0
Australian Research Council
Address [1] 284690 0
Level 2, 11 Lancaster Place
Majura Place ACT 2609
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
Not yet submitted
Ethics committee name [1] 286688 0
Ethics committee address [1] 286688 0
Ethics committee country [1] 286688 0
Date submitted for ethics approval [1] 286688 0
12/02/2012
Approval date [1] 286688 0
Ethics approval number [1] 286688 0

Summary
Brief summary
The rationale of the study is to evaluate the roles of exercise and yoga 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, (b) Cognitive Behaviour Therapy Combined with Yoga, and (c) Cognitive Behaviour Therapy with Delayed Exercise in reducing posttraumatic stress disorder symptoms. It is hypothesised that whereas all 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 Yoga or Cognitive Behaviour Therapy with Delayed Exercise.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33759 0
Address 33759 0
Country 33759 0
Phone 33759 0
Fax 33759 0
Email 33759 0
Contact person for public queries
Name 17006 0
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
r.bryant@unsw.edu.au
Contact person for scientific queries
Name 7934 0
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
r.bryant@unsw.edu.au

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