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Trial registered on ANZCTR


Registration number
ACTRN12611001065987
Ethics application status
Approved
Date submitted
11/10/2011
Date registered
12/10/2011
Date last updated
1/08/2019
Date data sharing statement initially provided
1/08/2019
Date results information initially provided
1/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Therapy for acute posttrauma stress after recent sexual assault
Scientific title
Treatment of acute stress disorder secondary to sexual assault in adults: Effectiveness of cognitive processing therapy compared with treatment as usual in a community mental health setting
Secondary ID [1] 273171 0
Nil
Universal Trial Number (UTN)
U1111-1125-1932
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute posttraumatic stress 278922 0
depression 278923 0
Condition category
Condition code
Mental Health 279102 279102 0 0
Anxiety
Mental Health 279131 279131 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive processing therapy (CPT): participants receive 6 weekly sessions of a trauma-focussed cognitive behavioural psychological therapy, with each session being 90min duration. Therapy is conducted one on one with counsellor (social worker). Cognitive behavioural therapy techniques involves helping participants modify unhelpful beliefs that contribute to anxiety and stress, and methods to reduce the frequency and distress associated with trauma memories.
Intervention code [1] 269524 0
Treatment: Other
Intervention code [2] 269525 0
Behaviour
Comparator / control treatment
Treatment as usual (TAU): participants receive standard counselling as normally received in a rape and sexual assault service.
Control group
Active

Outcomes
Primary outcome [1] 279774 0
Primary outcome 1: Mean posttraumatic stress disorder (PTSD) severity score derived from the Clinician-Administered PTSD Scale.
Timepoint [1] 279774 0
Timepoint: pretreatment, posttreatment, 3-months after treatment, 6-months after treatment.
Primary outcome [2] 279775 0
Primary outcome 2: Mean PTSD severity score on PTSD Checklist.
Timepoint [2] 279775 0
Timepoint: pretreatment, posttreatment, 3-months after treatment, 6-months after treatment.
Secondary outcome [1] 294404 0
Secondary outcome: Mean Beck depression score.
Timepoint [1] 294404 0
Timepoint: pretreatment, posttreatment, 3-months after treatment, 6-months after treatment.

Eligibility
Key inclusion criteria
Has experienced a sexual assault within past 4 weeks and is diagnosed with Acute Stress Disorder.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Client actively suicidal, has uncontrolled psychosis or bipolar disorder, is in current threat (e.g., is being actively stalked by a perpetrator), meets criteria for substance dependence, is already receiving psychotherapy for the index assault.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple sequential randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
SA

Funding & Sponsors
Funding source category [1] 270020 0
Charities/Societies/Foundations
Name [1] 270020 0
AUSTRALIAN ROTARY HEALTH RESEARCH FUND
Address [1] 270020 0
ARHRF; PO Box 779 Parramatta NSW 2124,

or

ARHRF; Rotary Down Under House, 3rd Floor, 43 Hunter St, NSW Parramatta, 2150
Country [1] 270020 0
Australia
Primary sponsor type
Individual
Name
A/Prof. Reg Nixon
Address
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 268995 0
None
Name [1] 268995 0
Address [1] 268995 0
Country [1] 268995 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271977 0
CHILDREN, YOUTH & WOMEN'S HEALTH SERVICE (CYWHS) HUMAN RESEARCH ETHICS COMMITTEE (HREC)
Ethics committee address [1] 271977 0
72 King William Road
North Adelaide SA 5006
Ethics committee country [1] 271977 0
Australia
Date submitted for ethics approval [1] 271977 0
Approval date [1] 271977 0
23/04/2008
Ethics approval number [1] 271977 0
REC2040/2/11

Summary
Brief summary
The study has several aims: (1) to test whether cognitive processing therapy (CPT) is helpful after recent trauma; (2) to test that CPT is as good as the usual therapy delivered in the sexual assault service (treatment as usual, TAU); (3) to ensure that counsellors not previously trained in CPT can learn and deliver the therapy with the same results as previous studies that have used highly experienced and trained cognitive behavioural therapists. We predict that CPT will be useful in reducing posttraumatic stress, that it will be at a minimum as good as treatment as usual, and we hypothesise that CPT therapists will show results comparable to previous treatment outcome studies using CPT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33242 0
Prof Reg Nixon
Address 33242 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 33242 0
Australia
Phone 33242 0
+61 8 820 12748
Fax 33242 0
Email 33242 0
reg.nixon@flinders.edu.au
Contact person for public queries
Name 16489 0
Prof Reg Nixon
Address 16489 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 16489 0
Australia
Phone 16489 0
61 8 8201 2748
Fax 16489 0
Email 16489 0
reg.nixon@flinders.edu.au
Contact person for scientific queries
Name 7417 0
Prof A/Prof. Reg Nixon
Address 7417 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 7417 0
Australia
Phone 7417 0
61 8 8201 2748
Fax 7417 0
Email 7417 0
reg.nixon@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not at this time, as original ethics did not explicitly allow for data sharing.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 3670 0
Reginald D.V. Nixon, Talitha Best, Sarah R. Wilksch, Samantha Angelakis,
Lisa J. Beatty and Nathan Weber. Behaviour Change, 33, 2016 pp. 232–250
doi 10.1017/bec.2017.2
Attachments [1] 3670 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary