Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.nhmrc.gov.au/

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

Federal/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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22893166

Publication citations

  1. 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.

Editorial Notes