Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000228381
Ethics application status
Not yet submitted
Date submitted
29/04/2008
Date registered
2/05/2008
Date last updated
2/05/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of combined cognitive behavioural therapy for alcohol use problems and social phobia
Scientific title
For comorbid alcohol use and social anxiety disorders does combined cognitive behavioural therapy (CBT) do better than CBT for alcohol alone in improving symptoms of either anxiety or alcohol or quality of life
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
comorbid Social anxiety disorder and alcohol use disorder 3094 0
Condition category
Condition code
Mental Health 3252 3252 0 0
Anxiety
Mental Health 3253 3253 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive behaviour therapy combining cognitive therapy for social anxiety disoder, and motivational interviewing and CBT based coping skills for alcohol use disorders in eight two hour group sessions
Intervention code [1] 2835 0
Treatment: Other
Comparator / control treatment
Cognitive behaviour therapy for alcohol use disorders in eight two hour group sessions
Control group
Active

Outcomes
Primary outcome [1] 4136 0
Symptoms of social anxiety disorder as assessed by a composite of the Social Phobia Scale and Social Interaction Anxiety scale, Brief Fear of Negative Evaluation Scale, and Social Phobia subscale of the Albany Panic and Phobia Questionnaire
Timepoint [1] 4136 0
3 and six months post treatment
Primary outcome [2] 4137 0
Symptoms of Alcohol use disorders, alcohol consumption, alcohol related problems, alcohol dependence as assessd by the number of tandard drinks per drinking occasion, assessed using the Time Line Follow Back procedure, and the Severity of Alcohol Dependence Questionnaire.
Timepoint [2] 4137 0
three and six months post treatment
Primary outcome [3] 4138 0
Quality of Life as assessed by the Short Form 12 (SF-12)
Timepoint [3] 4138 0
three and six months post treatment
Secondary outcome [1] 6974 0
symptoms of depression as assessed by the Depression, Anxiety, and Stress Scales
Timepoint [1] 6974 0
three and six months

Eligibility
Key inclusion criteria
adults (aged 18 years and older) who consume alcohol at harmful levels (men consuming 29 standard drinks of alcohol per week or more and women 14 standard drinks per week or more) and have a current (DSM-IV) diagnosis of social phobia; have a basic literacy and ability to communicate in English
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active or florid psychosis,
History of schizophrenia spectrum disorder or bipolar disorder,
Current active suicidal intent,
Current injecting drug use,
Dependence on benzodiazepines or other substances (other than tobacco)
Need for intensive detoxification (a score = 20 on CIWA-AR) (upon completion of detoxification participants will be eligible for inclusion),
Inability to provide locator information or inability to participate in treatment and booster sessions

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3343 0
Government body
Name [1] 3343 0
NHMRC Project Grant
Country [1] 3343 0
Australia
Primary sponsor type
Individual
Name
Dr Andrew Baillie
Address
Psychology Department
Macquarie University NSW 2109
Country
Australia
Secondary sponsor category [1] 2988 0
Individual
Name [1] 2988 0
Dr Claudia Sannibale
Address [1] 2988 0
National Drug and Alcohol Research Centre
University of New South Wales NSW 2055
Country [1] 2988 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5367 0
Ethics committee address [1] 5367 0
Ethics committee country [1] 5367 0
Date submitted for ethics approval [1] 5367 0
14/03/2008
Approval date [1] 5367 0
Ethics approval number [1] 5367 0
Ethics committee name [2] 5368 0
Ethics committee address [2] 5368 0
Ethics committee country [2] 5368 0
Date submitted for ethics approval [2] 5368 0
14/03/2008
Approval date [2] 5368 0
Ethics approval number [2] 5368 0

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

Contacts
Principal investigator
Name 28556 0
Address 28556 0
Country 28556 0
Phone 28556 0
Fax 28556 0
Email 28556 0
Contact person for public queries
Name 11713 0
Dr Andrew Baillie
Address 11713 0
Psychology Department
Macquarie University NSW 2109
Country 11713 0
Australia
Phone 11713 0
02 9850 9436
Fax 11713 0
Email 11713 0
andrew.baillie@mq.edu.au
Contact person for scientific queries
Name 2641 0
Dr Andrew Baillie
Address 2641 0
Psychology Department
Macquarie University NSW 2109
Country 2641 0
Australia
Phone 2641 0
02 9850 9436
Fax 2641 0
Email 2641 0
andrew.baillie@mq.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
SourceTitleYear of PublicationDOI
EmbaseRandomised controlled trial of integrated cognitive behavioural treatment and motivational enhancement for comorbid social anxiety and alcohol use disorders.2021https://dx.doi.org/10.1177/0004867420952539
Dimensions AIAn investigator-blinded, randomized study to compare the efficacy of combined CBT for alcohol use disorders and social anxiety disorder versus CBT focused on alcohol alone in adults with comorbid disorders: the Combined Alcohol Social Phobia (CASP) trial protocol2013https://doi.org/10.1186/1471-244x-13-199
N.B. These documents automatically identified may not have been verified by the study sponsor.