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ISRCTN
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ISRCTN12908171
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DOI
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10.1186/ISRCTN12908171
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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The efficacy of an intervention for post traumatic stress disorder among illicit drug users
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Scientific title
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Acronym
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N/A
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Serial number at source
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NHMRC Project Grant 455209
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Study hypothesis
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Participants who receive an integrated treatment for their Post Traumatic Stress Disorder (PTSD) and substance use (treatment group) will demonstrate greater reductions in PTSD symptoms and substance use compared to those who receive standard care for their substance use alone (control group).
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Lay summary
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Not provided at time of registration
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Ethics approval
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Approval granted by the University of New South Wales (HREC 06064).
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Study design
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Randomised controlled trial.
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Post traumatic stress disorder and substance use disorders
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Participants - inclusion criteria
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1. 18 years of age or older
2. Lifetime exposure to at least one traumatic event
3. Screen positive for current (past month) PTSD
4. Use of drugs other than alcohol at least four times in the past month
5. Literate in English
6. Willing to give locator information
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Participants - exclusion criteria
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1. Current suicidality or recent self-harming behaviours
2. Chronic psychosis
3. Cognitive impairment sufficient to interfere with therapy
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Anticipated start date
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23/04/2007
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Anticipated end date
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31/12/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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150
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Interventions
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The treatment group will receive an integrated treatment for PTSD and substance dependence called 'Concurrent Treatment with Prolonged Exposure'. Concurrent Treatment with Prolonged Exposure involves 13 individual weekly 90 minute sessions with a clinical psychologist, incorporating Cognitive Behavioural Therapy (CBT) for substance use and PTSD. CBT for PTSD includes cognitive therapy, imaginal and in vivo exposure.
The control group will receive treatment as usual (standard care) for their substance use.
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Primary outcome measure(s)
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Reduction in PTSD symtpoms and drug use will be measured at 6 weeks, 3 and 9 months post-baseline.
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Secondary outcome measure(s)
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Improvements in other treatment outcomes including their overall physical and mental health will also be measured at 6 weeks, 3 and 9 months post-baseline using the following:
1. Short Form 12 questionnaire (for assessment of general physical and mental health)
2. Beck Depression Inventory II
3. State Trait Anxiety Inventory
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Sources of funding
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National Health and Medical Research Council (Australia)
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Trial website
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Publications
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1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22893166
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Contact name
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Dr
Katherine
Mills
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Address
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National Drug & Alcohol Research Centre, University of NSW
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City/town
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Sydney
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Zip/Postcode
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2052
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Country
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Australia
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Tel
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+612 9385 0253
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Fax
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+612 9385 0222
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Email
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k.mills@unsw.edu.au
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Sponsor
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National Health and Medical Research Council (Australia)
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Address
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GPO Box 1421
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City/town
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Canberra
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Zip/Postcode
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2601
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Country
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Australia
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Email
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grantnet.help@nhmrc.gov.au
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Sponsor website:
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http://www.nhmrc.gov.au/
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Date applied
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02/04/2007
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Last edited
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16/08/2012
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Date ISRCTN assigned
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15/05/2007
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