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Trial registered on ANZCTR


Registration number
ACTRN12608000506392
Ethics application status
Approved
Date submitted
19/08/2008
Date registered
30/09/2008
Date last updated
10/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Integrated treatment for alcohol problems and comorbid post-traumatic stress disorder
Scientific title
A randomised controlled trial of the efficacy of integrated treatment for post-traumatic stress disorder and alcohol use problems as determined by post-treatment alcohol consumption and severity of symptoms of post-traumatic stress disorder
Secondary ID [1] 287849 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol use disorder and co-existing post-traumatic stress disorder 3219 0
Condition category
Condition code
Mental Health 3382 3382 0 0
Addiction
Mental Health 3383 3383 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two intervention groups in this study. Both groups receive 12x90 minute sessions of therapy over 12 weeks. Groups 1 and 2 both receive therapy for alcohol problems which consists of motivational therapy and cognitive behaviour therapy. Motivational therapy consists of specific strategies designed to consolidate readiness and commitment to reduce or stop alcohol consumption. Cognitive behaviour therapy consists of strategies that assist participants to identify and redress cognitions and behaviours that impede effective coping. Group 1 also receives prolonged exposure for post-traumatic stress disorder. Prolonged exposure involves repeated recounting of distressing trauma memories. Group 2 receives supportive counselling for posttraumatic stress disorder. Group 1 receives 12x90 minute sessions of therapy for alcohol problems and exposure for post-traumatic stress disorder; Group 2 receives 12x90 minute sessions of treatment for alcohol problems and supportive counselling.
Intervention code [1] 2959 0
Treatment: Other
Comparator / control treatment
Therapy consists of 12x90 minute weekly sessions of motivation enhancement therapy, cognitive behaviour therapy and supportive counselling. Motivation enhancement therapy consists of strategies that increase readiness and commitment for change. Cognitive bahaviour therapy teaches individuals to identify and change unhelpful beliefs and behaviour. Supportive counselling consists of empathic listening and practical problem solving.
Control group
Active

Outcomes
Primary outcome [1] 4277 0
Alcohol consumption (measured by the Time Line Follow-back), alcohol depedence scale score (Severity of Alcohol Dependnece questionnaire)
Timepoint [1] 4277 0
Baseline, end of treatment and 3- and 6-months after treatment.
Primary outcome [2] 4278 0
Severity of post-traumatic stress symptoms as measured by the Clinician Administered Post-Traumatic Stress Scale (PTSD) and Post-traumatic Diagnostic Scale
Timepoint [2] 4278 0
Baseline, end of treatment, and 3- 6-months after treatment
Secondary outcome [1] 7210 0
alcohol problems (Short Inventory of Problems), Drinking Motives Questionnaire
Timepoint [1] 7210 0
Baseline, end of treatment and 3- and 6-months following treatment cessation.
Secondary outcome [2] 7904 0
depression (BDI) and anxiety (STAI)
Timepoint [2] 7904 0
Baseline, end of treatment and 3- and 6-months following treatment cessation.
Secondary outcome [3] 7905 0
Post-traumatic Cognitions Inventory
Timepoint [3] 7905 0
Baseline, end of treatment and 3- and 6-months following treatment cessation.
Secondary outcome [4] 7906 0
Time to relapse (Time Line Follow-back)
Timepoint [4] 7906 0
end of treatment and 3- and 6-months following treatment cessation.
Secondary outcome [5] 7907 0
General functioning (SF12, WHO8, Service Use)
Timepoint [5] 7907 0
Baseline, end of treatment and 3- and 6-months following treatment cessation.

Eligibility
Key inclusion criteria
Adults who consume alcohol at high-risk levels (men: 29 or more drinks per week; women: 15 or more drinks per week) and currently meet criteria for post-traumatic stress disorder (Clinician Administered PTSD Scale), basic literacy and ability to communicate in English.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Psychosis (Structured Clinical Interview for the Diagnostic Statistical Manual-IV) or past history of psychosis, current suicidal intent (Beck Depression Inventory), injecting drug use (Opiate Treatment Index score of 1 or more), need for residential withdrawal management (Clinical Institute Withdrawal Assessment for Alcohol score 20 or more) (participants will be eligible after completing alcohol withdrawal)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random allocation follows completion of baseline assessment. Allocation to treatment condition is concealed in sealed, opaque, envelopes numbered sequentially and held centrally.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer generated randomisation table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/09/2007
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
31/10/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
144
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3754 0
Government body
Name [1] 3754 0
National Health and Medical Research Council
Country [1] 3754 0
Australia
Primary sponsor type
Individual
Name
Dr Claudia Sannibale
Address
National Drug and Alcohol Research Centre
University of New South Wales
22-32 King Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 3367 0
None
Name [1] 3367 0
Address [1] 3367 0
Country [1] 3367 0
Other collaborator category [1] 392 0
Individual
Name [1] 392 0
Prof Maree Teesson
Address [1] 392 0
National Drug and Alcohol Research Centre
University of New South Wales
22-32 King Street
Randwick NSW 2031
Country [1] 392 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5863 0
Ethics Review Committee, Sydney South Western Area Health Service
Ethics committee address [1] 5863 0
Ethics committee country [1] 5863 0
Australia
Date submitted for ethics approval [1] 5863 0
Approval date [1] 5863 0
16/03/2007
Ethics approval number [1] 5863 0
X07-0020

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28636 0
Dr Claudia Sannibale
Address 28636 0
Drug Health Services
Royal Prince Alfred Hospital
Level 6 King George V Building
Missenden Road
Camperdown NSW 2050
Country 28636 0
Australia
Phone 28636 0
+ 61 2 9515 7611
Fax 28636 0
61 2 9515 8970
Email 28636 0
claudia.sannibale@email.cs.nsw.gov.au
Contact person for public queries
Name 11793 0
Dr Claudia Sannibale
Address 11793 0
National Drug and Alcohol Research Centre (NDARC)
University of New South Wales (UNSW)
22-32 King Street,
Randwick NSW 2031

Postal Address:
NDARC UNSW
Sydney NSW 2052
Country 11793 0
Australia
Phone 11793 0
+61 2 93850259
Fax 11793 0
+61 2 93850222
Email 11793 0
c.sannibale@unsw.edu.au
Contact person for scientific queries
Name 2721 0
Dr Claudia Sannibale
Address 2721 0
National Drug and Alcohol Research Centre (NDARC)
University of New South Wales (UNSW)
22-32 King Street,
Randwick NSW 2031

Postal Address:
NDARC UNSW
Sydney NSW 2052
Country 2721 0
Australia
Phone 2721 0
+61 2 93850259
Fax 2721 0
+61 2 93850222
Email 2721 0
c.sannibale@unsw.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.