ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000618954

Ethics application status

Approved

Date submitted

27/05/2011

Date registered

16/06/2011

Date last updated

23/07/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Enhancing residential substance abuse treatment with computer interventions

Scientific title

A randomised trial of a computer-based depression intervention for individuals attending a residential substance abuse program.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Alcohol and substance abuse

Depression

Condition category

Condition code

Mental Health

Addiction

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Computer delivered motivational interviewing and cognitive behavioural therapy (SHADE therapy: Self-Help for Alcohol and other drug use and Depression). Individuals in this condition will complete 2 x 50 minute sessions of the SHADE program each week, over a period of 5 weeks.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Intervention code [3]

Behaviour

Comparator / control treatment

A computer delivered touch typing skills program (Type Master Pro). Individuals in this condition will complete 2 x 50 minute sessions of the Type Master Pro each week, over a period of 5 weeks.

Control group

Active

Outcomes

Primary outcome [1]

Opiate Treatment Index (OTI)

Timepoint [1]

3 months

Primary outcome [2]

Beck Depression Inventory (BDI-II)

Timepoint [2]

5 weeks and 3 months

Secondary outcome [1]

Dysfunctional Attitudes Questionnaire

Timepoint [1]

5 weeks and 3 months

Secondary outcome [2]

Drug Taking Confidence Questionnaire (DTCQ)

Timepoint [2]

5 weeks and 3 months

Secondary outcome [3]

Drug Risk Response Test (DRRT)

Timepoint [3]

5 week and 3 months

Secondary outcome [4]

Ways of Responding (WOR)

Timepoint [4]

5 weeks and 3 months

Secondary outcome [5]

PENN Alcohol Cravings Questionnaire

Timepoint [5]

5 weeks and 3 months

Eligibility

Key inclusion criteria

All participants attending The Salvation Army William Booth Program will be asked to participate. All participants will have an alcohol or other substance abuse disorder. Previous surveys of The Salvation Army program indicates that approximately 50% of participants report a previous mental health diagnosis.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Significant acquired brain injury

People who's primary language is other than english

People who are acutely suicidal

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)

Participants will be in the first 3-weeks of the William Booth Program. They will complete a structured interview with a research assistant. At the completion of the interview they will be randomly allocated to one of the conditions (1) Treatment (SHADE) or (2) Active Control (Type Master Pro). .

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

All participants upon entry to the study will be given a unique numerical code. This unique code will have previously been randomly assigned a treatment allocation using a random numbers table. The treatment assignment will be written on a piece of paper, and inserted into a blank envelope with the unique participant code written on the front of the envelope. Upon completion of the
initial assessment, the participant will be asked to open the relevant envelope (the one with their unique code entered on the front) to reveal their treatment allocation. The randomisation procedure will stratify for both gender and whether the person is currently taking antidepressant
medication to ensure the proportion of males & females, and individuals with a history of depression is consistent across the two groups. Randomisation will be blocked so that the distribution of participants across treatment conditions will be maintained regardless of the final sample size.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

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

11/04/2011

Actual

4/03/2011

Date of last participant enrolment

Anticipated

Actual

3/12/2012

Date of last data collection

Anticipated

Actual

3/12/2012

Sample size

Target

200

Accrual to date

Final

189

Recruitment in Australia

Recruitment state(s)

NSW,QLD

Recruitment postcode(s) [1]

2000 - Sydney

Recruitment postcode(s) [2]

4059 - Red Hill

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Rotary Health

Address [1]

PO Box 3455
Parramatta, NSW 2124
Australia

Country [1]

Australia

Primary sponsor type

University

Name

The University of Wollongong

Address

Wollongong Campus
Wollongong, NSW
2522

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of New South Wales

Address [1]

UNSW KENSINGTON CAMPUS
SYDNEY, NSW
2052

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

University of Newcastle

Address [2]

Callaghan Campus
Callaghan, NSW
2308

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Wollongong Human Research Ethics Committee

Ethics committee address [1]

Wollongong Campus
University of Wollongong
Wollongong, NSW
2522

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/03/2011

Ethics approval number [1]

HE09/091

Summary

Brief summary

It is extremely common for individuals with substance abuse disorders to also have co-occurring mental health problems. Approximately 60% of participants at Australian residential rehabilitation services report a previous mental health diagnosis, with depressive disorders being the most common. Individuals with co-occurring mental health problems typically have a poorer treatment response and higher rates of relapse. Integrated treatment approaches are recommended for residential substance abuse programs, where both the person’s substance abuse and co-occurring mental health problems are concurrently addressed. However, the majority of residential substance abuse services still primarily target the person’s substance abuse problems. 

One approach to improve treatment is to utilise computer-based self-help programs. Benefits of computer-based approaches to residential settings include: a) the low costs associated with delivering the intervention; b) it doesn’t require additional staff members or training; and c) participants can continue to access the program should they leave the facility early. There is a growing body of literature supporting the usefulness of computer delivered interventions for mental health problems. Additionally, computer-based interventions have been recommended as a way to improve the use of evidence based approaches within routine care. However, only limited controlled dissemination research has been conducted in this area.

The aim of the present study is to examine the effectiveness of using a computer delivered comorbidity treatment program for individuals attending long-term residential substance abuse programs. The study will be conducted as a real-world randomized trial, where the Treatment Condition will complete the computer-delivered intervention in addition to treatment as usual.

Trial website

Trial related presentations / publications

Kelly, P. J., Kay-Lambkin, F. J., Baker, A. L., Deane, F. P., Brooks, A. C., Mitchell, A.,  Marshall, S., Whittington, M., & Dingle, G. A. (2012). Study protocol: A randomized controlled trial of a computer-based depression and substance abuse intervention for people attending residential substance abuse treatment. BMC Public Health. doi:10.1186/1471-2458-12-113.

Public notes

Contacts

Principal investigator

Name

Dr Peter Kelly

Address

Northfields Avenue,
School of Psychology,
University of Wollongong
NSW, Australia 2500

Country

Australia

Phone

+61 2 42 39 23 82

Fax

pkelly@uow.edu.au

Contact person for public queries

Name

Peter Kelly

Address

School of Psychology
Wollongong Campus
University of Wollongong
NSW, 2522

Country

Australia

Phone

+61 2 42 39 2382

Fax

pkelly@uow.edu.au

Contact person for scientific queries

Name

Peter Kelly

Address

School of Psychology
Wollongong Campus
University of Wollongong
NSW, 2522

Country

Australia

Phone

+61 2 42 39 2382

Fax

pkelly@uow.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

Source	Title	Year of Publication	DOI
Embase	Study protocol: a randomized controlled trial of a computer-based depression and substance abuse intervention for people attending residential substance abuse treatment.	2012	https://dx.doi.org/10.1186/1471-2458-12-113

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

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Documents added manually

Documents added automatically