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Trial registered on ANZCTR
Registration number
ACTRN12605000203651
Ethics application status
Approved
Date submitted
17/08/2005
Date registered
23/08/2005
Date last updated
23/08/2005
Type of registration
Retrospectively registered
Titles & IDs
Public title
A Controlled Breathing Course Promoting Social and Emotional Health for Vietnam Veterans with Chronic Posttraumatic Stress Disorder - A Randomized Controlled Trial
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Scientific title
A Controlled Breathing Course Promoting Social and Emotional Health for Vietnam Veterans with Chronic Posttraumatic Stress Disorder - A Randomized Controlled Trial
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Universal Trial Number (UTN)
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Trial acronym
SKY - PTSD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Post-traumatic Stress Disorder
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Condition category
Condition code
Mental Health
321
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
22 hour intervention over 5 days
Day 1 Getting acquainted. Some discussion of life issues, and training in 3-stage Ujjayi and Bhastrika breathing. Homework - practice of above plus philosophical question to ponder overnight.
Day 2 Discussion of homework, knowledge points, Ujjayi and Bhastrika practice in group, group process, and philosophical question to ponder overnight.
Day 3 Mild yoga stretches, homework review, knowledge points, group processes, Ujjayi, Bhastrika, long Sudarshan Kriya with variable breath lengths, rest, processing, homework.
Day 4 Mild yoga stretches, homework review, knowledge points, Ujjayi, Bhastrika, long Sudarshan Kriya, rest, processing, homework and instruction in home practice - 30 minutes.
Day 5 Homework practice before coming to group. Mild yoga stretches, knowledge, information about follow up sessions, group closure and saying goodbye.
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Intervention code [1]
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None
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Comparator / control treatment
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Control group
Active
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Outcomes
Primary outcome [1]
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To decrease the symptoms of Posttraumatic Stress Disorder. A Pretest screening will be done by a qualified professional on the CAPS (PTSD test); Alcohol survey; Mini-Plus (Co-morbid conditions with PTSD tested) and Qol-Bref tests (Quality of Life Survey). Results will be recorded and this should show a decrease in symptoms of PTSD, depression and alcohol abuse.
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Assessment method [1]
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Timepoint [1]
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During the course a self-administered PCL-M (PTSD checklist) will be done every days and a self administered CES-D test (depression test) at the beginning and the end of the course. An alcohol log will also be kept by each participant. The intervention will be performed for the next six weeks once a week and a PCL-M (PTSD check list) and a CES-D (Depression scale) self administered will be done. After the six weeks a qualified professional will re-administer the pre-screening tests.
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Primary outcome [2]
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To a more healthy lifestyle. A Pretest screening will be done by a qualified professional on the CAPS (PTSD test); Alcohol survey; Mini-Plus (Co-morbid conditions with PTSD tested) and Qol-Bref tests (Quality of Life Survey). Results will be recorded and this should show a decrease in symptoms of PTSD, depression and alcohol abuse.
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Assessment method [2]
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Timepoint [2]
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During the course a self-administered PCL-M (PTSD checklist) will be done every days and a self administered CES-D test (depression test) at the beginning and the end of the course. An alcohol log will also be kept by each participant. The intervention will be performed for the next six weeks once a week and a PCL-M (PTSD check list) and a CES-D (Depression scale) self administered will be done. After the six weeks a qualified professional will re-administer the pre-screening tests.
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Secondary outcome [1]
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To assist with an concomitant depression or alcohol dependence.
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Assessment method [1]
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Timepoint [1]
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The CES-D test (depression test) which is administered as in the Primary outcomes will track the depressions scores over the course and the weekly intervention.
Alcohol dependence will be tracked by the alcohol log and the alcohol audit done in the pre-screening and post test.
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Eligibility
Key inclusion criteria
Suffering chronic post traumatic stress disorder tested by CAPS. Vietnam Veterans. Adequate cognition.
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Minimum age
Not stated
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Maximum age
Not stated
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Inadequate cognition. Suicidality. Psychosis. Substance abuse other than alcohol.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Matched pairs random computer allocation to one of two groups. The research assistant who did the allocation did not participate in the trial
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Matched pairs random computer allocation to one of two groups. Matched pairs were high alcohol consumption and had a similar caps score or high depression score or combinations of all three or PTSD alone
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
1/03/2005
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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Primary sponsor type
University
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Name
University of Queensland
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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None
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Queensland Medical Research Ethics Committee
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Ethics committee address [1]
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
1367
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Ethics approval number [1]
1367
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Summary
Brief summary
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Janis Carter
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Address
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PO Box 1557
Cooparoo DC QLD 4151
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Country
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Australia
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Phone
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+61 7 33976425
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Fax
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+61 7 33975280
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Janis Carter
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Address
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PO Box 1557
Cooparoo DC QLD 4151
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Country
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Australia
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Phone
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+61 7 33976425
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Fax
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+61 7 33975280
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Email
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[email protected]
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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.
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