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The efficacy of an intervention for post traumatic stress disorder among illicit drug users
ISRCTN ISRCTN12908171
DOI 10.1186/ISRCTN12908171
ClinicalTrials.gov identifier
EudraCT number
Public title The efficacy of an intervention for post traumatic stress disorder among illicit drug users
Scientific title
Acronym N/A
Serial number at source NHMRC Project Grant 455209
Study hypothesis 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).
Lay summary Not provided at time of registration
Ethics approval Approval granted by the University of New South Wales (HREC 06064).
Study design Randomised controlled trial.
Countries of recruitment Australia
Disease/condition/study domain Post traumatic stress disorder and substance use disorders
Participants - inclusion criteria 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
Participants - exclusion criteria 1. Current suicidality or recent self-harming behaviours
2. Chronic psychosis
3. Cognitive impairment sufficient to interfere with therapy
Anticipated start date 23/04/2007
Anticipated end date 31/12/2009
Status of trial Completed
Patient information material
Target number of participants 150
Interventions 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.
Primary outcome measure(s) Reduction in PTSD symtpoms and drug use will be measured at 6 weeks, 3 and 9 months post-baseline.
Secondary outcome measure(s) 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
Sources of funding National Health and Medical Research Council (Australia)
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22893166
Contact name Dr  Katherine  Mills
  Address National Drug & Alcohol Research Centre, University of NSW
  City/town Sydney
  Zip/Postcode 2052
  Country Australia
  Tel +612 9385 0253
  Fax +612 9385 0222
  Email k.mills@unsw.edu.au
Sponsor National Health and Medical Research Council (Australia)
  Address GPO Box 1421
  City/town Canberra
  Zip/Postcode 2601
  Country Australia
  Email grantnet.help@nhmrc.gov.au
  Sponsor website: http://www.nhmrc.gov.au/
Date applied 02/04/2007
Last edited 16/08/2012
Date ISRCTN assigned 15/05/2007
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