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Trial registered on ANZCTR


Registration number
ACTRN12607000057482
Ethics application status
Approved
Date submitted
10/02/2006
Date registered
18/01/2007
Date last updated
11/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The DAISI Project – Depression & Alcohol Integrated & Single-focused Interventions
Scientific title
Impact of single-focused versus integrated cognitive behaviour therapy
on the levels of co-occurring depression and alcohol use problems:
randomised controlled trial
Secondary ID [1] 262249 0
DAISI
Universal Trial Number (UTN)
Trial acronym
DAISI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 1550 0
Hazardous alcohol use 1551 0
Condition category
Condition code
Mental Health 1650 1650 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(i) 10-once weekly sessions of cognitive behaviour therapy (CBT) that target depression only;
(ii) 10-once weekly sessions of CBT that target alcohol use only;
(iii) 10-once weekly sessions of CBT that target depression and alcohol use concurrently;
(iv) Brief intervention (one session) that targets depression and alcohol use concurrently.
Intervention code [1] 893 0
None
Comparator / control treatment
The Brief intervention is the control treatment. This is a single session of feedback from the assessment, case formulation and provision of self help reading material that targets depression and alcohol use concurrently.
Control group
Active

Outcomes
Primary outcome [1] 2276 0
Levels of depression
Timepoint [1] 2276 0
Measured at baseline, at completion of treatment and again at 6-months, 12-months, 24-months and 36-months post initial assessment.
Primary outcome [2] 2277 0
Levels of alcohol use
Timepoint [2] 2277 0
Measured at baseline, at completion of treatment and again at 6-months, 12-months, 24-months and 36-months post initial assessment.
Secondary outcome [1] 3984 0
Symptomatology, psychosocial and neuropsychological functioning.
Timepoint [1] 3984 0
Measured at baseline, at completion of treatment and again at 6-months, 12-months, 24-months and 36-months post initial assessment.

Eligibility
Key inclusion criteria
(a) any person who is experiencing current levels of depressive symptoms (score at least 17 on the Beck Depression Inventory-II); and (b) who is also consuming alcohol at harmful levels. Harmful consumption of alcohol will be defined as consumption above recommended NHMRC guidelines for males and females (i.e. in excess of 2-4 standard drinks per day for males and 1-2 standard drinks for females, with fewer than 2 alcohol-free days).
Minimum age
16 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) any participant who screens positive for psychotic illness ); (b) people who are not using alcohol above recommended levels. NOTE: People may be using drugs in addition to alcohol and still be eligible for participation; (c) any participants requiring medical detoxification for their alcohol use will initially be referred to the appropriate service in the community. However, once the physical symptoms of withdrawal are managed, it is important to follow up with some form of further treatment, so at this time these participants will be recruited to the study; (d) any participants who exhibit significant learning difficulties; (e) non-English speakers; (f) people with organic brain diseases.

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)
A randomisation list generated by the Research Manager was linked to a unique participant identification code. Treatment allocations are transferred from this list by an Administrative Assistant and concealed in individual envelopes labelled with the relevant participant code. Neither the Research Manager nor the Administrative Assistant are involved with the assessment or treatment phases of the study. Prior to the brief intervention session for each participant, the research clinicians are issued with a new randomisation envelope by the Administrative Assistant, which displayed the participant number on the outside of the envelope, with the treatment allocation sealed inside. This envelope is opened by the research participant at the conclusion of the brief intervention session.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation - using computer generated randomisation stratified by study location (Newcastle, Orange or Brisbane), gender (male or female), antidepressant use (yes or no) and pharmacotherapy for alcohol use (yes or no).
Masking / blinding
Open (masking not 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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 204 0
2300

Funding & Sponsors
Funding source category [1] 1797 0
Government body
Name [1] 1797 0
NHMRC Grant
Address [1] 1797 0
Level 5, 20 Allara Street,
Canberra ACT 2601
Country [1] 1797 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive Callaghan New South Wales 2308
Country
Australia
Secondary sponsor category [1] 1616 0
University
Name [1] 1616 0
University of Queensland
Address [1] 1616 0
The University of Queensland
Brisbane QLD 4072 Australia
Country [1] 1616 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3354 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 3354 0
Ethics committee country [1] 3354 0
Australia
Date submitted for ethics approval [1] 3354 0
Approval date [1] 3354 0
19/07/2006
Ethics approval number [1] 3354 0
H-066-0705
Ethics committee name [2] 3355 0
Hunter Area Research Ethics Committee
Ethics committee address [2] 3355 0
Ethics committee country [2] 3355 0
Australia
Date submitted for ethics approval [2] 3355 0
Approval date [2] 3355 0
19/07/2006
Ethics approval number [2] 3355 0
05/05/11/3.13
Ethics committee name [3] 3356 0
Human Research Ethics Committee-University of Queensland
Ethics committee address [3] 3356 0
Ethics committee country [3] 3356 0
Australia
Date submitted for ethics approval [3] 3356 0
Approval date [3] 3356 0
30/11/2005
Ethics approval number [3] 3356 0
2005000568
Ethics committee name [4] 3357 0
Coast Human Research Ethics Committee
Ethics committee address [4] 3357 0
Ethics committee country [4] 3357 0
Australia
Date submitted for ethics approval [4] 3357 0
Approval date [4] 3357 0
19/12/2005
Ethics approval number [4] 3357 0
05/58
Ethics committee name [5] 3358 0
Human Research Ethics Committee-Greater Western Area Health Service
Ethics committee address [5] 3358 0
Ethics committee country [5] 3358 0
Australia
Date submitted for ethics approval [5] 3358 0
Approval date [5] 3358 0
19/12/2005
Ethics approval number [5] 3358 0

Summary
Brief summary
The DAISI project is investigating treatments for comorbid depression
and alcohol use disorders. Specifically, this project aims to directly
compare the effectiveness of four approaches to psychological treatment
with varying emphasis on depression and alcohol use.

Four programs of Cognitive Behaviour Therapy (CBT) and motivational
interviewing will be delivered, and outcomes compared over a 3-year
period:
(i) 10-sessions of CBT that targets depression only (CBT-Dep);
(ii) 10-sessions of CBT that targets alcohol use only (CBT-Alc);
(iii) 10-sessions of CBT that targets depression and alcohol use
concurrently (CBT-Int); and
(iv) Brief intervention that targets depression and alcohol use
concurrently (BI - control).

It is hypothesised that this research will result in the development of
an effective treatment program for people with comorbid alcohol and
depressive disorders. We further hypothesise that the integrated CBT
(CBT-Int) will produce greater, more sustainable reductions in both
depressive and alcohol use outcomes relative to the other treatment
conditions at the post-treatment follow-up assessments.

The knowledge obtained through this research would assist counsellors in
the field of alcohol and other drug treatment and mental health
professionals to choose the most appropriate treatment for their clients
who present with this comorbidity.
Trial website
Trial related presentations / publications
Baker, A.L., Kavanagh, D.J., Kay-Lambkin, F.J., Hunt, S.A., Lewin, T.J., Carr, V.J., & Connolly, J. (2010). Randomized controlled trial of cognitive-behavioural therapy for coexisting depression and alcohol problems: short-term outcome, Addiction, 105, 87-99.

Hunt, S.A., Baker, A.L., Michie, P.T., & Kavanagh, D.J. (2009). Neurocognitive profiles of people with comorbid depression and alcohol use: Implications for psychological interventions, Addictive Behaviors, 34, 878-886.

Baker, A. (2010). Two randomised controlled trials of CBT for co-existing depression and substance use problems.
Oral presentation by Amanda Baker at the 27th International Congress of Applied Psychology, Melbourne.

Bailey, K., Baker, A., & Webster, R. (2010). Trauma event and psychological sequalae.
Oral presentation by Kylie Bailey at the Australasian Professional Society on Alcohol and Other Drugs Conference, Canberra.

Baker, A. (2009). The long and the short of treatments for alcohol or cannabis misuse among people with major depression or psychosis.
Keynote address by Amanda Baker at the Western Australia Drug and Alcohol Conference, Fremantle.

Hunt, S.A., Baker, A.L., Kay-Lambkin, F.J., Lewin, T.J., Michie, P., & Kavanagh, D.J. (2009). Cognitive profiles for comorbid depression and alcohol use disorders: Impact on response to treatment.
Oral presentation by Sally Hunt at the International Society for Affective Disorders Regional Congress, Brisbane.

Baker, A., Kavanagh, D., Hunt, S., Kay-Lambkin, F., Lewin, T., Carr, V. Integrated vs single-focussed treatment for depression and alcohol use problems: A randomised controlled trial.
Oral presentation by Amanda Baker at the International Society for Affective Disorders Regional Congress, Brisbane.

Hunt, S.A., Baker, A.L., Kavanagh, D.J., Kay-Lambkin, F.J., Lewin, T.J., & Carr, V.J. (2008). A Randomised controlled trial of integrated and single focused interventions for co-morbid depression and alcohol use disorders.
Oral presentation by Sally Hunt at the Australasian Society for Psychiatric Research Annual Conference, Newcastle.

Hunt, S., Baker,A., Kavanagh, D.J., Kay-Lambkin, F., Lewin, T., Carr, V. (2008). Combined versus single focused interventions for comorbid depression and alcohol problems: the DAISI project.
Oral presentation by Amanda Baker at the Australian Professional Society on Alcohol and Other Drugs Conference, Sydney.

Hunt, S., Baker, A., & Michie, P. (2008). Neurocognitive Profiles of People Receiving Cognitive Behaviour Therapy.
Oral presentation by Sally Hunt at the NSW Health Drug and Alcohol Research Colloquium, Sydney.

Bailey, K., Webster, R., and Baker, A. (2008). PTSD and trauma symptoms in a comorbid depressed and alcohol use population.
Oral presentation by Kylie Bailey at the 30th National Australian Association for Cognitive-Behaviour Therapy Conference, Adelaide.

Baker, A., Kavanagh, D., Kay-Lambkin, F., Hunt, S., Lewin, T.J., & Carr, V. (2007). Combined versus single focused interventions for co-morbid depression and alcohol problems: the DAISI project.
Oral presentation by Amanda Baker at the World Congress of Behavioral and Cognitive Therapies, Barcelona, Spain.

Hunt, S.A., Baker, A.L., Kavanagh, D.J., Kay-Lambkin, F.J., Lewin, T.J., Kelly, B., & Carr, V.J. (2007). Neuropsychological functioning in people with comorbid depression and alcohol use: Interim results from the DAISI study.
Oral presentation by Sally Hunt at the World Congress of Behavioural and Cognitive Therapies, Barcelona, Spain.

Hunt, S.A., Baker, A.L., Kavanagh, D.J., Kay-Lambkin, F.J., Lewin, T.J., Kelly, B., & Carr, V.J. (2006). Combined versus single focused interventions for comorbid depression and alcohol problems: Introduction to the DAISI project.
Oral presentation by Sally Hunt at the Australian Association for Cognitive and Behaviour Therapy Annual Conference, Sydney.

Hunt, S.A., Baker, A.L., Kavanagh, D.J., Kay-Lambkin, F.J., Lewin, T.J., Kelly, B., & Carr, V.J. (2006). Combined versus single focused interventions for comorbid depression and alcohol problems: Introduction to the DAISI project.
Oral presentation by Sally Hunt at the Australian Winter School, Brisbane.

Hunt, S.A., Baker, A.L., Kavanagh, D.J., Kay-Lambkin, F.J., Lewin, T.J., Kelly, B., & Carr, V.J. (2005). Combined versus single focused interventions for comorbid depression and alcohol problems: Introduction to the DAISI project.
Oral presentation by Sally Hunt at the Australasian Society for Psychiatric Research Annual Conference, Brisbane.
Public notes

Contacts
Principal investigator
Name 35803 0
Prof Amanda Baker
Address 35803 0
University Drive, Callagan, NSW, 2298
Country 35803 0
Australia
Phone 35803 0
(02) 4033 5690
Fax 35803 0
Email 35803 0
Amanda.Baker@newcastle.edu.au
Contact person for public queries
Name 10082 0
Prof Amanda Baker
Address 10082 0
Centre for Brain and Mental Health Research
PO Box 833
Newcastle 2300
NSW
Country 10082 0
Australia
Phone 10082 0
+61 2 40335690
Fax 10082 0
+61 2 40335692
Email 10082 0
Amanda.Baker@newcastle.edu.au
Contact person for scientific queries
Name 1010 0
Prof Amanda Baker
Address 1010 0
Centre for Brain and Mental Health Research
PO Box 833
Newcastle 2300
NSW
Country 1010 0
Australia
Phone 1010 0
+61 2 40335690
Fax 1010 0
+61 2 40335692
Email 1010 0
Amanda.Baker@newcastle

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary