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Trial registered on ANZCTR


Trial ID
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
Scientific title
A Controlled Breathing Course Promoting Social and Emotional Health for Vietnam Veterans with Chronic Posttraumatic Stress Disorder - A Randomized Controlled Trial
Universal Trial Number (UTN)
Trial acronym
SKY - PTSD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-traumatic Stress Disorder 284 0
Condition category
Condition code
Mental Health 321 321 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 204 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 375 0
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.
Timepoint [1] 375 0
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.
Primary outcome [2] 376 0
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.
Timepoint [2] 376 0
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.
Secondary outcome [1] 836 0
To assist with an concomitant depression or alcohol dependence.
Timepoint [1] 836 0
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.

Eligibility
Key inclusion criteria
Suffering chronic post traumatic stress disorder tested by CAPS. Vietnam Veterans. Adequate cognition.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inadequate cognition. Suicidality. Psychosis. Substance abuse other than alcohol.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
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
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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] 378 0
Self funded/Unfunded
Name [1] 378 0
Address [1] 378 0
Country [1] 378 0
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 303 0
None
Name [1] 303 0
None
Address [1] 303 0
Country [1] 303 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1367 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 1367 0
Ethics committee country [1] 1367 0
Australia
Date submitted for ethics approval [1] 1367 0
Approval date [1] 1367 0
Ethics approval number [1] 1367 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35794 0
Address 35794 0
Country 35794 0
Phone 35794 0
Fax 35794 0
Email 35794 0
Contact person for public queries
Name 9393 0
Dr Janis Carter
Address 9393 0
PO Box 1557
Cooparoo DC QLD 4151
Country 9393 0
Australia
Phone 9393 0
+61 7 33976425
Fax 9393 0
+61 7 33975280
Email 9393 0
jjanisca@bigpond.net.au
Contact person for scientific queries
Name 321 0
Dr Janis Carter
Address 321 0
PO Box 1557
Cooparoo DC QLD 4151
Country 321 0
Australia
Phone 321 0
+61 7 33976425
Fax 321 0
+61 7 33975280
Email 321 0
jjanisca@bigpond.net.au