ANZCTR - Registration

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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

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Posttraumatic Stress Disorder

Condition category

Condition code

Mental Health

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]

Behaviour

Intervention code [2]

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]

Posttraumatic stress disorder, as measured by the Clinician Administered PTSD Scale.

Timepoint [1]

Pretreatment, posttreatment, 6-Month Follow-up

Secondary outcome [1]

Depression, as measured by the Beck Depression Inventory.

Timepoint [1]

Pretreatment, posttreatment, 6-Month Follow-up

Secondary outcome [2]

Cognitive appraisals as measured by the Posttraumatic Cognitions Inventory

Timepoint [2]

Pretreatment, posttreatment, and 6-month follow-up

Secondary outcome [3]

Anxiety as measured by the Beck Anxiety Inventory.

Timepoint [3]

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?

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]

Westmead Hospital - Westmead

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Research Council

Address [1]

Level 2, 11 Lancaster Place
Majura Place ACT 2609

Country [1]

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]

Hospital

Name [1]

Westmead Hospital

Address [1]

O'Brien's Road, Westmead, NSW, 2145

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Westmead Hospital, Hawkesbury Rd, Westmead, NSW, 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/02/2012

Approval date [1]

09/10/2012

Ethics approval number [1]

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]

http://www.anzctr.org.au/AnzctrAttachments/362081-ptsd exercise ssa approval letter .pdf (Ethics approval)

Attachments [2]

http://www.anzctr.org.au/AnzctrAttachments/362081(v08-06-2018-20-28-42)-ptsd exercise ssa approval letter .pdf (Ethics approval)

Attachments [3]

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

Prof Richard Bryant

Address

School of Psychology, University of New South Wales, Sydney, NSW, 2052

Country

Australia

Phone

+61293853640

Fax

r.bryant@unsw.edu.au

Contact person for public queries

Name

Professor Richard Bryant

Address

School of Psychology
University of New South Wales
Sydney, NSW, 2052

Country

Australia

Phone

61-2-93853640

Fax

61-2-93853641

r.bryant@unsw.edu.au

Contact person for scientific queries

Name

Professor Richard Bryant

Address

School of Psychology
University of New South Wales
Sydney, NSW, 2052

Country

Australia

Phone

61-2-93853640

Fax

61-2-93853641

r.bryant@unsw.edu.au

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 (r.bryant@unsw.edu.au)

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

Source	Title	Year of Publication	DOI
Embase	Neural activity during response inhibition associated with improvement of dysphoric symptoms of PTSD after trauma-focused psychotherapy-an EEG-fMRI study.	2021	https://dx.doi.org/10.1038/s41398-021-01340-8
Embase	Augmenting trauma-focused psychotherapy for post-traumatic stress disorder with brief aerobic exercise in Australia: a randomised clinical trial.	2023	https://dx.doi.org/10.1016/S2215-0366%2822%2900368-6

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

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Documents added manually

Documents added automatically