Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12610001085066
Ethics application status
Not yet submitted
Date submitted
8/12/2010
Date registered
10/12/2010
Date last updated
10/12/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Cognitive Behavior Therapy and Supportive Counselling for Reduction in Posttraumatic Stress Disorder (PTSD) Symptoms in Acehnese Adults
Scientific title
Randomised Controlled Trial of Cognitive Behavior Therapy and Supportive Counselling for Reduction in Posttraumatic Stress Disorder (PTSD) Symptoms in Acehnese Adults
Secondary ID [1] 253262 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder 258793 0
Condition category
Condition code
Mental Health 258936 258936 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of intervention(s) / exposure: There are 2 arms to this trial. Arm 1:Cognitive Behaviour Therapy. Arm 2: Supportive Counselling. Therapy is administered in once-weekly 60-minute sessions of one-on-one therapy with a counsellor over 6 weeks. Cognitive Behaviour Therapy includes imaginal reliving of trauma memories, in vivo exposure that includes gradual exposure to feared situations, and cognitive restructuring of the trauma experience. The duration of the study for any participant will conclude after the 6-month follow-up assessment, resulting in participation duration of 8 months.
Intervention code [1] 257727 0
Behaviour
Comparator / control treatment
Comparator / control treatment: The Supportive Counselling condition involves 6 once-weekly 60-minute sessions of individual therapy over 6 weeks. The therapy includes nondirective counselling that does not include any Cognitive Behaviour Therapy components. The duration of the study for any participant will conclude after the 6-month follow-up assessment, resulting in participation duration of 8 months.
Control group
Active

Outcomes
Primary outcome [1] 259798 0
Posttraumatic stress disorder as measured by the Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale
Timepoint [1] 259798 0
Pretreatment, Posttreatment, 6-Month Follow-Up
Secondary outcome [1] 268598 0
Depression as measured by the Beck Depression Inventory
Timepoint [1] 268598 0
Pretreatment, Posttreatment, 6-Month Follow-Up

Eligibility
Key inclusion criteria
(1) Exposure to trauma in Aceh, (2) Meet criteria for PTSD
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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 women attending a servvice in Aceh. Participants will be randomly assigned 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 center.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted by a process of minimization stratified on gender, trauma type, and Posttraumatic Stress Disorder severity.
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
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3081 0
Indonesia
State/province [1] 3081 0
Aceh

Funding & Sponsors
Funding source category [1] 258189 0
Government body
Name [1] 258189 0
Australian Research Council
Country [1] 258189 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, Australia
Country
Australia
Secondary sponsor category [1] 257364 0
Other Collaborative groups
Name [1] 257364 0
Yayasan Mulia Hati
Address [1] 257364 0
Jalan Sentosa 29A
Meulaboh, Aceh
Country [1] 257364 0
Indonesia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260180 0
Ethics committee address [1] 260180 0
Ethics committee country [1] 260180 0
Date submitted for ethics approval [1] 260180 0
01/01/2011
Approval date [1] 260180 0
Ethics approval number [1] 260180 0

Summary
Brief summary
This study will randomly allocate patients with PTSD to either (a)cognitive behaviour therapy, or (b) supportive counselling.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32002 0
Address 32002 0
Country 32002 0
Phone 32002 0
Fax 32002 0
Email 32002 0
Contact person for public queries
Name 15249 0
Professor Richard Bryant
Address 15249 0
School of Psychology
University of New South Wales, Anzac Parade, Kensington,
Sydney, NSW, 2052
Country 15249 0
Australia
Phone 15249 0
61-2-93853640
Fax 15249 0
61-2-93853641
Email 15249 0
[email protected]
Contact person for scientific queries
Name 6177 0
Professor Richard Bryant
Address 6177 0
School of Psychology
University of New South Wales, Anzac Parade, Kensington,
Sydney, NSW, 2052
Country 6177 0
Australia
Phone 6177 0
61-2-93853640
Fax 6177 0
61-2-93853641
Email 6177 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.