Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001190291
Ethics application status
Approved
Date submitted
12/07/2018
Date registered
17/07/2018
Date last updated
5/11/2019
Date data sharing statement initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the Efficacy of a Cognitive Remediation Intervention in Alcohol and Other Drug Residential Treatment Services
Scientific title
A stepped wedge cluster randomised trial of a cognitive remediation intervention in alcohol and other drug residential treatment services
Secondary ID [1] 295477 0
Nil known
Universal Trial Number (UTN)
U1111-1216-9703
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance Use Disorder 308741 0
Condition category
Condition code
Mental Health 307678 307678 0 0
Addiction
Public Health 307679 307679 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention to be provided is the Cognitive Remediation in Drug and Alcohol Services (CRiDAS) Program.

The manualised Cognitive Remediation in Drug and Alcohol Services (CRiDAS) program will be used for CR, which consists of 12 one-hour group-based sessions that will take place across six weeks (two sessions per week). Each session will be dedicated to strategy training, which includes traditional instructional pedagogical approaches, modelling, exercises to demonstrate concepts, and role-plays. The CR intervention was developed with a strong emphasis on the training of EF in view of the finding that EF is particularly impaired in an AOD treatment population. Barkley’s (2001; 2012) evolutionary model of EF was used to structure a large part of the program. The CR program will use a “top-down” approach, including training in compensatory strategy use with a particular emphasis on EF. The modules cover the following topics: brain functioning, attention, visual and verbal working memory, emotion regulation, decision-making and problem-solving.

Facilitators will be staff of the residential AOD treatment sites who will undergo training to administer the intervention. Facilitators will be selected by AOD service management based on a minimum skillset, including experience in AOD rehabilitation and confidence in leading groups. No formal qualification standards were set. Training will consist of a two-day workshop led by a senior clinical neuropsychologist, who will also provide regular supervision throughout the duration of the intervention. In addition, a website will be set up to allow discussion of the CRiDAS program between facilitators from different sites. Facilitators will be able to use this at their discretion, with no requirements for the amount of use.

Facilitators will deliver the intervention in a face-to-face manner at the residential treatment site, to groups of approximately 20-26 residents. Once the CRiDAS program has been implemented in a residential drug and alcohol service, the program will continue to be run until the end of the study.

An independent researcher/clinician will use the CRiDAS treatment fidelity measure to measure fidelity via audio/video recordings of 10% of the sessions at each site.
Intervention code [1] 301815 0
Treatment: Other
Intervention code [2] 301816 0
Rehabilitation
Comparator / control treatment
The comparator will be a six-week period of treatment-as-usual at each of the residential treatment sites. The content of treatment-as-usual will vary between each sites, including factors such as the duration of the overall treatment program and the components of treatment within the program. All sites will be residential and have a program duration of at least 10 weeks. All sites will be abstinence-based although a portion of participants at the sites may be receiving prescribed medications or opioid-substitution therapy.

Each "treatment phase" of the stepped wedge study will be a six week period of either treatment-as-usual or cognitive remediation. These will be interspersed by two-week "test phases" in which outcomes will be assessed. In the initial "treatment phase", all sites will undergo treatment-as-usual for six weeks. In treatment phase 2, three sites will be selected at random to implement the CriDAS program (six weeks) while the remaining seven sites will continue to offer treatment as usual. Once introduced, the sites will continue to offer the CRiDAS program during treatment phases until the end of the study. In treatment phase 3, another three sites will be selected at random to implement the CRiDAS program, and in treatment phase 4, the final four sites will introduce the CRiDAS program. A table representing the program of the stepped wedge has been uploaded as a supporting document.
Control group
Active

Outcomes
Primary outcome [1] 306681 0
Behavior Rating Inventory of Executive Function – Adult Version (BRIEF-A; Roth et al., 2005). The Global Executive Composite (GEC) provides an overall summary score. The primary outcome variable will be the difference between pre- and post-cognitive remediation/treatment-as-usual.
Timepoint [1] 306681 0
The GEC will be measured in the two weeks prior to a six-week cognitive remediation/treatment-as-usual period, and in the two weeks following.
Primary outcome [2] 306682 0
Time in Treatment: Time residents spend in treatment (length of stay) as a proportion of program duration will be used as a primary outcome variable.
Timepoint [2] 306682 0
The time in the treatment of participants will continue to be monitored until all participants have been discharged from their program (either through drop-out or graduation). This is anticipated to be approximately six to nine months after the final testing phase.
Primary outcome [3] 306683 0
Comparison of historical retention data for the drug and alcohol services with retention rates following the introduction of the CRiDAS program.
Timepoint [3] 306683 0
12 months following the introduction of the CRiDAS program in each site.
Secondary outcome [1] 349239 0
Severity of Dependence Scale (SDS; Gossop et al., 2007). The outcome variable will be total score.
Timepoint [1] 349239 0
In the 2 weeks following a six-week period of either the CRiDAS program or treatment-as-usual.
Secondary outcome [2] 349240 0
Health Service Utilisation. For consenting participants, the number of visits to health services in the year prior to and following commencement of CR will be compared. These data will be obtained from the Centre for Health Record Linkage (CheRel) database. Total Health Service Utilisation will be an outcome variable.
Timepoint [2] 349240 0
12 months following the end of the final treatment phase of the study (February 2020).
Secondary outcome [3] 349241 0
Brief Executive Assessment Tool (BEAT; Berry et al., unpublished). The outcome variable will be total score.
Timepoint [3] 349241 0
In the 2 weeks following a six-week period of either the CRiDAS program or treatment-as-usual.
Secondary outcome [4] 349242 0
Stroop Task (Golden, 1978). The outcome variable will be total score on the third condition.
Timepoint [4] 349242 0
In the 2 weeks following a six-week period of either the CRiDAS program or treatment-as-usual.
Secondary outcome [5] 349243 0
Five-Point Test (5PT; Goebel et al., 2009). The outcome variable will be total designs correctly completed.
Timepoint [5] 349243 0
In the 2 weeks following a six-week period of either the CRiDAS program or treatment-as-usual.
Secondary outcome [6] 349245 0
Alpha Span Task (Craik, Bialystok, Gillingham & Stuss, 2017). The outcome variable will be the total alpha score as described by Craik et al., (2017).
Timepoint [6] 349245 0
In the 2 weeks following a six-week period of either the CRiDAS program or treatment-as-usual.
Secondary outcome [7] 349246 0

Symbol Digit Modalities Test (SDMT; Smith, 1982). The outcome will be total score.
Timepoint [7] 349246 0
In the 2 weeks following a six-week period of either the CRiDAS program or treatment-as-usual.
Secondary outcome [8] 349247 0
Brief Self-Control Scale (BSCS; Tangney et al., 2004). The outcome variable will be total score.
Timepoint [8] 349247 0
In the 2 weeks following a six-week period of either the CRiDAS program or treatment-as-usual.
Secondary outcome [9] 349248 0
EUROQOL – EQ-5D-5l (EQ-5D; Brazier, Jones & Kind, 1993). The outcome measure will be total score.
Timepoint [9] 349248 0
In the 2 weeks following a six-week period of either the CRiDAS program or treatment-as-usual.
Secondary outcome [10] 349249 0
EUROHIS-QOL 8-item index (EUROHIS-QOL 8; Schmidt et al., 2006). The outcome measure will be total score.
Timepoint [10] 349249 0
In the 2 weeks following a six-week period of either the CRiDAS program or treatment-as-usual.
Secondary outcome [11] 349250 0
Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF; Endicott et al., 1993). Total score will be used as the outcome variable.
Timepoint [11] 349250 0
In the 2 weeks following a six-week period of either the CRiDAS program or treatment-as-usual.
Secondary outcome [12] 349251 0
Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS Global 10; Hays et al., 2009) Total QOL score will be used as the outcome variable.
Timepoint [12] 349251 0
In the 2 weeks following a six-week period of either the CRiDAS program or treatment-as-usual.
Secondary outcome [13] 349252 0
Kessler Psychological Distress Scale Plus (K10+; Kessler et al., 2007). The outcome variable will be total score.
Timepoint [13] 349252 0
In the 2 weeks following a six-week period of either the CRiDAS program or treatment-as-usual.
Secondary outcome [14] 349253 0
Goal Attainment Scaling 2.0 (GAS 2.0; Berry et al., unpublished). GAS 2.0 derives a primary goal on the basis of: a) current level and b) maximum realistic level. The outcome variable will be GAS score.
Timepoint [14] 349253 0
In the 2 weeks following a six-week period of either the CRiDAS program or treatment-as-usual.
Secondary outcome [15] 349254 0
Australian Treatment Outcomes Profile (ATOP; Ryan, et al., 2014): Drug use in the previous four weeks. The outcome variable will be drug use in the previous 4 weeks compared to the 4 weeks prior to receiving treatment.
Timepoint [15] 349254 0
The measure will be administered at post-discharge follow up (2, 4, 6 & 8-months following receipt of CRiDAS/Treatment-as-usual) while the study is running.
Secondary outcome [16] 349485 0
Health Service Utilisation: Patient Admissions related to Substance Use.

For consenting participants, the number of patient admissions to health services in the year prior to and following receipt of CR will be compared. These data will be obtained from the Centre for Health Record Linkage (CheRel) database. Patient admissions will be the outcome variable.
Timepoint [16] 349485 0
12 months following the end of the final treatment phase of the study (February 2020).
Secondary outcome [17] 349486 0
Health Service Utilisation: Emergency Department Admissions.

For consenting participants, the number of patient admissions to emergency departments in the year prior to and following receipt of CR will be compared. These data will be obtained from the Centre for Health Record Linkage (CheRel) database. Emergency department admissions will be the outcome variable.
Timepoint [17] 349486 0
12 months following the end of the final treatment phase of the study (February 2020).
Secondary outcome [18] 349487 0
Health Service Utilisation: Utilisation of Mental Health Services.

For consenting participants, the number of patient ambulatory mental health services attended in the year prior to and following receipt of CR will be compared. These data will be obtained from the Centre for Health Record Linkage (CheRel) database. Participant attendance at mental health services will be the outcome variable.
Timepoint [18] 349487 0
12 months following the end of the final treatment phase of the study (February 2020).
Secondary outcome [19] 349488 0
Mortality Rates. For consenting participants, mortality rates in the year after receipt of TAU or CR will be obtained from the Centre for Health Record Linkage (CheRel) database. Percent mortality from groups who receivied TAU or CR will be the outcome variable.
Timepoint [19] 349488 0
12 months following the end of the final treatment phase of the study (February 2020).
Secondary outcome [20] 349489 0
Australian Treatment Outcomes Profile (ATOP; Ryan, et al., 2014): Homelessness. The outcome variable will be rates of homelessness in the previous 4 weeks.
Timepoint [20] 349489 0
The measure will be administered at post-discharge follow up (2, 4, 6 & 8-months following receipt of CRiDAS/Treatment-as-usual) while the study is running.
Secondary outcome [21] 349490 0
Australian Treatment Outcomes Profile (ATOP; Ryan, et al., 2014): Risk of Eviction. The outcome variable will be rates of eviction risk in the previous 4 weeks.
Timepoint [21] 349490 0
The measure will be administered at post-discharge follow up (2, 4, 6 & 8-months following receipt of CRiDAS/Treatment-as-usual) while the study is running.
Secondary outcome [22] 349491 0
Australian Treatment Outcomes Profile (ATOP; Ryan, et al., 2014): Arrests. The outcome variable will be number of arrests in the previous 4 weeks.
Timepoint [22] 349491 0
The measure will be administered at post-discharge follow up (2, 4, 6 & 8-months following receipt of CRiDAS/Treatment-as-usual) while the study is running.
Secondary outcome [23] 349492 0
Australian Treatment Outcomes Profile (ATOP; Ryan, et al., 2014): Violence towards others. The outcome variable will be rates of self-reported violence towards others in the previous 4 weeks.
Timepoint [23] 349492 0
The measure will be administered at post-discharge follow up (2, 4, 6 & 8-months following receipt of CRiDAS/Treatment-as-usual) while the study is running.
Secondary outcome [24] 349494 0
Australian Treatment Outcomes Profile (ATOP; Ryan, et al., 2014): Victim of violence. The outcome variable will be the number of positive responses to "someone was violent towards you" in the previous 4 weeks. .
Timepoint [24] 349494 0
The measure will be administered at post-discharge follow up (2, 4, 6 & 8-months following receipt of CRiDAS/Treatment-as-usual) while the study is running.
Secondary outcome [25] 349495 0
Australian Treatment Outcomes Profile (ATOP; Ryan, et al., 2014): Days of Paid Work/Education. The outcome variable will be a number of days of paid work or involvement in formal education (e.g. school, TAFE, university) in the previous 4 weeks. Paid work and education will be amalgamated into a composite variable.
Timepoint [25] 349495 0
The measure will be administered at post-discharge follow up (2, 4, 6 & 8-months following receipt of CRiDAS/Treatment-as-usual) while the study is running.

Eligibility
Key inclusion criteria
Ten drug and alcohol services in NSW have been invited to participate in the study. Participants will be attending the ten residential treatment programs and enrolled in treatment for alcohol and other drug problems. In order to maximise the ecological validity of the results, participants with comorbid medical, psychiatric or mental health disorders will be included, as will adults receiving opioid substituion therapy (e.g. methadone).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents in treatment who are aged 17 and younger will be excluded from the present study.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order in which services (clusters) were identified to receive treatment was selected using simple randomisation (computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
A stepped-wedge design will be used in which clusters will cross over from receiving treatment-as-usual to receiving the CRiDAS program.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
It is estimated that 440 participants will be recruited into the study. This is based on an average of 20 participants recruited from the 10 AOD sites selected to implement the present study, and the assumption that as people are discharged from the service, new people will enter and be recruited into the present study. It is assumed that of these 440 people, 40% will be discharged from services before completing a phase of the CRiDAS intervention or Treatment-As-Usual (and providing post-test data).

Baseline characteristics will be summarised using means and standard deviations or frequencies and percentages as appropriate. The primary outcome variable will be the BRIEF-A GEC score and the effect of the intervention will be estimated using a linear mixed model. The model will include the baseline BRIEF-A GEC as a covariate and a fixed effect for each time period after baseline to account for any secular trends. We will also include random effects for treatment centre, time within centre and individual within centre to account for the clustering, repeated measurements on centre and repeated measures on individuals respectively. The main predictor of interest will be a pre-/post-intervention variable, which will measure the overall effect of the intervention. The data will be analysed according to the intent-to-treat principle, with sensitivity analysis undertaken to include all participants under an appropriate multiple imputation model for the missing data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
23/07/2018
Actual
24/07/2018
Date of last participant enrolment
Anticipated
18/01/2019
Actual
22/01/2019
Date of last data collection
Anticipated
29/02/2020
Actual
Sample size
Target
440
Accrual to date
Final
527
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300066 0
Government body
Name [1] 300066 0
Agency for Clinical Innovation
Country [1] 300066 0
Australia
Primary sponsor type
Individual
Name
Dr Jamie Berry
Address
Advanced Neuropsychological Treatment Services
PO Box 4070
Strathfield South NSW 2136
Country
Australia
Secondary sponsor category [1] 299462 0
Government body
Name [1] 299462 0
Agency for Clinical Innovation
Address [1] 299462 0
Agency for Clinical Innovation.
Level 4, 67 Albert Avenue, Chatswood NSW 2067
PO Box 699, Chatswood NSW 2057
Country [1] 299462 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300913 0
Macquarie University Human Research Ethics Committee (HREC (Medical Sciences))
Ethics committee address [1] 300913 0
Ethics committee country [1] 300913 0
Australia
Date submitted for ethics approval [1] 300913 0
07/02/2018
Approval date [1] 300913 0
27/03/2018
Ethics approval number [1] 300913 0
5201935398673

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2886 2886 0 0
/AnzctrAttachments/375549-Table 1. Study Design.docx (Supplementary information)

Contacts
Principal investigator
Name 85254 0
Dr Jamie Berry
Address 85254 0
Advanced Neuropsychological Treatment Services
PO Box 4070
Strathfield South NSW 2136
Country 85254 0
Australia
Phone 85254 0
+61 2 1300 224 331
Fax 85254 0
Email 85254 0
[email protected]
Contact person for public queries
Name 85255 0
Jamie Berry
Address 85255 0
Advanced Neuropsychological Treatment Services
PO Box 4070
Strathfield South NSW 2136
Country 85255 0
Australia
Phone 85255 0
+61 2 1300 224 331
Fax 85255 0
Email 85255 0
[email protected]
Contact person for scientific queries
Name 85256 0
Talia Nardo
Address 85256 0
Advanced Neuropsychological Treatment Services
PO Box 4070
Strathfield South NSW 2136
Country 85256 0
Australia
Phone 85256 0
+61 2 1300 224 331
Fax 85256 0
Email 85256 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Undecided if unidentified IPD will be made available on request.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
499Study protocol    https://bmcpsychiatry.biomedcentral.com/articles/1... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA stepped wedge cluster randomised trial of a cognitive remediation intervention in alcohol and other drug (AOD) residential treatment services.2019https://dx.doi.org/10.1186/s12888-019-2044-4
N.B. These documents automatically identified may not have been verified by the study sponsor.