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
Scientific
National Drug & Alcohol Research Centre, University of NSW
Sydney
2052
Australia
| Phone | +612 9385 0253 |
|---|---|
| k.mills@unsw.edu.au |
Study information
| Study design | Randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Approval granted by the University of New South Wales (HREC 06064). |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 23/04/2007 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key 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 |
| Key exclusion criteria | 1. Current suicidality or recent self-harming behaviours 2. Chronic psychosis 3. Cognitive impairment sufficient to interfere with therapy |
| Date of first enrolment | 23/04/2007 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Australia
Study participating centre
National Drug & Alcohol Research Centre, University of NSW
Sydney
2052
Australia
2052
Australia
Sponsor information
National Health and Medical Research Council (Australia)
Research council
Research council
GPO Box 1421
Canberra
2601
Australia
| grantnet.help@nhmrc.gov.au | |
| Website | http://www.nhmrc.gov.au/ |
"ROR" |
https://ror.org/011kf5r70 |
Funders
Funder type
Research council
National Health and Medical Research Council (Australia)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
