Contact information
Type
Scientific
Primary contact
Dr Katherine Mills
ORCID ID
Contact details
National Drug & Alcohol Research Centre
University of NSW
Sydney
2052
Australia
+612 9385 0253
k.mills@unsw.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NHMRC Project Grant 455209
Study information
Scientific title
Acronym
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).
Ethics approval
Approval granted by the University of New South Wales (HREC 06064).
Study design
Randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Post traumatic stress disorder and substance use disorders
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Reduction in PTSD symtpoms and drug use will be measured at 6 weeks, 3 and 9 months post-baseline.
Secondary outcome measures
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
Overall trial start date
23/04/2007
Overall trial end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Current suicidality or recent self-harming behaviours
2. Chronic psychosis
3. Cognitive impairment sufficient to interfere with therapy
Recruitment start date
23/04/2007
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Australia
Trial participating centre
National Drug & Alcohol Research Centre, University of NSW
Sydney
2052
Australia
Sponsor information
Organisation
National Health and Medical Research Council (Australia)
Sponsor details
GPO Box 1421
Canberra
2601
Australia
grantnet.help@nhmrc.gov.au
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
National Health and Medical Research Council (Australia)
Alternative name(s)
NHMRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Australia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22893166
Publication citations
-
Results
Mills KL, Teesson M, Back SE, Brady KT, Baker AL, Hopwood S, Sannibale C, Barrett EL, Merz S, Rosenfeld J, Ewer PL, Integrated exposure-based therapy for co-occurring posttraumatic stress disorder and substance dependence: a randomized controlled trial., JAMA, 2012, 308, 7, 690-699, doi: 10.1001/jama.2012.9071.