The efficacy of an intervention for post traumatic stress disorder among illicit drug users

ISRCTN ISRCTN12908171
DOI https://doi.org/10.1186/ISRCTN12908171
Secondary identifying numbers NHMRC Project Grant 455209
Submission date
02/04/2007
Registration date
15/05/2007
Last edited
16/08/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Katherine Mills
Scientific

National Drug & Alcohol Research Centre, University of NSW
Sydney
2052
Australia

+612 9385 0253
k.mills@unsw.edu.au

Study information

Study designRandomised controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)
Study typeTreatment
Scientific title
Study objectivesParticipants 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(s)Approval granted by the University of New South Wales (HREC 06064).
Health condition(s) or problem(s) studiedPost traumatic stress disorder and substance use disorders
InterventionThe 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 typeOther
Primary outcome measureReduction in PTSD symtpoms and drug use will be measured at 6 weeks, 3 and 9 months post-baseline.
Secondary outcome measuresImprovements 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 study start date23/04/2007
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target number of participants150
Key inclusion criteria1. 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
Key exclusion criteria1. Current suicidality or recent self-harming behaviours
2. Chronic psychosis
3. Cognitive impairment sufficient to interfere with therapy
Date of first enrolment23/04/2007
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Australia

Study participating centre

National Drug & Alcohol Research Centre, University of NSW
Sydney
2052
Australia

Sponsor information

Funders

Funder type

Research council

National Health and Medical Research Council (Australia)
Government organisation / National government
Alternative name(s)
National Health and Medical Research Council, Australian Government, NHMRC National Health and Medical Research Council, NHMRC
Location
Australia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 15/08/2012 Yes No
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