ANZCTR - Registration

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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]

DAISI

Universal Trial Number (UTN)

Trial acronym

DAISI

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Depression

Hazardous alcohol use

Condition category

Condition code

Mental Health

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]

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]

Levels of depression

Timepoint [1]

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]

Levels of alcohol use

Timepoint [2]

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]

Symptomatology, psychosocial and neuropsychological functioning.

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/10/2005

Actual

1/10/2005

Date of last participant enrolment

Anticipated

31/07/2007

Actual

31/07/2007

Date of last data collection

Anticipated

Actual

Sample size

Target

400

Accrual to date

Final

284

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

2300

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC Grant

Address [1]

Level 5, 20 Allara Street,
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of Newcastle

Address

University Drive Callaghan New South Wales 2308

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Queensland

Address [1]

The University of Queensland
Brisbane QLD 4072 Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

19/07/2006

Ethics approval number [1]

H-066-0705

Ethics committee name [2]

Hunter Area Research Ethics Committee

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

19/07/2006

Ethics approval number [2]

05/05/11/3.13

Ethics committee name [3]

Human Research Ethics Committee-University of Queensland

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

30/11/2005

Ethics approval number [3]

2005000568

Ethics committee name [4]

Coast Human Research Ethics Committee

Ethics committee address [4]

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

19/12/2005

Ethics approval number [4]

05/58

Ethics committee name [5]

Human Research Ethics Committee-Greater Western Area Health Service

Ethics committee address [5]

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

Approval date [5]

19/12/2005

Ethics approval number [5]

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

Prof Amanda Baker

Address

University Drive, Callagan, NSW, 2298

Country

Australia

Phone

(02) 4033 5690

Fax

[email protected]

Contact person for public queries

Name

Amanda Baker

Address

Centre for Brain and Mental Health Research
PO Box 833
Newcastle 2300
NSW

Country

Australia

Phone

+61 2 40335690

Fax

+61 2 40335692

[email protected]

Contact person for scientific queries

Name

Amanda Baker

Address

Centre for Brain and Mental Health Research
PO Box 833
Newcastle 2300
NSW

Country

Australia

Phone

+61 2 40335690

Fax

+61 2 40335692

Amanda.Baker@newcastle

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

Source	Title	Year of Publication	DOI
Dimensions AI	The Influence of Parental Emotional Neglect on Assault Victims Seeking Treatment for Depressed Mood and Alcohol Misuse: A Pilot Study	2016	https://doi.org/10.3390/jcm5100088

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically