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Trial registered on ANZCTR


Registration number
ACTRN12618001722280
Ethics application status
Approved
Date submitted
16/10/2018
Date registered
18/10/2018
Date last updated
18/12/2018
Date data sharing statement initially provided
18/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the effectiveness and feasibility of a cognitive remediation program in a residential substance use treatment facility
Scientific title
An evaluation of the effectiveness and feasibility of a cognitive remediation program in a residential substance use treatment facility
Secondary ID [1] 296348 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance use 310065 0
Condition category
Condition code
Mental Health 308821 308821 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name of intervention: Cognitive remediation.

A cognitive remediation program will be added to routine care in a residential rehabilitation facility for substance use. The intervention will be added to the standard rehabilitation program from approximately April to December 2019. Everyone who is a resident of the facility during this time will participate in the cognitive remediation program. Our trial is comparing standard care with standard care plus cognitive remediation.

The cognitive remediation program we are using is the Neuropsychological Educational Approach to Cognitive Remediation (NEAR) developed and manualised by Prof Alice Medalia, Columbia University, New York (Medalia et al 2009, 2017). The intervention will consist of 2-3 individual sessions to develop an individual case plan and treatment goals, then three group sessions per week for the duration of a resident's stay in the facility (up to three months). Group sessions entail participants engaging in computerised activities selected for them by the therapist (45 minutes), followed by a 'bridging group' led by the therapist, linking the computerised activities with real world tasks and goals. The computerised activities will be selected from at least two software suites, BrainHQ (www.brainhq.com) and HappyNeuron Pro (www.happyneuron-pro.com). Examples of activities are: (a) selecting faces which were previously presented, (b) repeating back rhythms, and (c) scanning the screen for small visual details. At least one (maximum two) individual session(s) will conclude the intervention for each participant, reviewing progress on individual goals and discussing how progress can be continued. The number of individual sessions will be determined by how long it takes for the therapist to complete the tasks for the sessions with that participant. It is expected that for most participants, two individual sessions prior to the group program and one individual session post group program will be sufficient to achieve the goals of these sessions. However some participants may require more time (or shorter individual sessions), due, for example, to poor concentration, slowed thinking speed or verbosity.

All interventions will be conducted face to face. The intervention will be implemented and overseen by a doctorate level Clinical Psychologist with over 15 years clinical experience, supported by Drug and Alcohol Workers at the residential rehabilitation facility.

Intervention fidelity will be maintained through initial training and ongoing supervision provided by the NEAR team from New York, and minimising the number of therapists delivering the intervention (one, supported by other staff).
Intervention code [1] 312675 0
Treatment: Other
Intervention code [2] 312676 0
Rehabilitation
Intervention code [3] 312677 0
Behaviour
Comparator / control treatment
The comparator group is 'treatment as usual' (standard care). Outcomes for residents completing the rehabilitation program during the period November 2018 to March 2019 will be compared with outcomes for residents completing the program during the period when cognitive remediation is added to the program, approximately April to December 2019.
Control group
Historical

Outcomes
Primary outcome [1] 307796 0
Overall cognitive functioning.

Assessed by:

Brief Assessment of Cognition (BAC-App; a battery of neuropsychological tests administered via tablet), total score.
Timepoint [1] 307796 0
1. Baseline (service entry)
2. Two months post baseline
3. Six months post baseline [primary timepoint]
Primary outcome [2] 307809 0
Level of cognitive functioning as relates to real-life functioning

Assessed by:

Schizophrenia Cognitive Rating Scale (SCoRS; interview based clinical assessment evaluating degree to which cognitive deficits impair day to day functioning), total score.
Timepoint [2] 307809 0
1. Baseline (service entry)
2. Two months post baseline
3. Six months post baseline [primary timepoint]
Primary outcome [3] 307810 0
Executive functioning

Assessed by:

Wisconsin Card Sorting Test (neuropsychological test of executive functioning; administered via web application)
Timepoint [3] 307810 0
1. Baseline (service entry)
2. Two months post baseline
3. Six months post baseline [primary timepoint]
Secondary outcome [1] 352945 0
Substance use

This is a composite outcome, assessed by a composite score from the following scales::

1. Severity of Dependence Scale (5 item self-report scale), total score.
2. WHO Alcohol, Smoking and Substance Involvement Screening Test (WHO-ASSIST V3; 8 item self-report scale), total score.
Timepoint [1] 352945 0
1. Baseline (service entry)
2. Two months post service entry
3. Six months post service entry
Secondary outcome [2] 352947 0
Psychological wellbeing/symptomatology

Assessed by:

Kessler Psychological Distress Scale (K10; ten item self-report scale for symptoms of anxiety and mood); total score.
Timepoint [2] 352947 0
1. Baseline (service entry)
2. Two months post service entry
3. Six months post service entry
Secondary outcome [3] 352948 0
Functional goal attainment

Assessed by:

Goal Attainment Scaling (GAS; a method of scoring the extent to which an individuals goals are achieved in the course of an intervention).
Timepoint [3] 352948 0
1. Two months post service entry
2. Six months post service entry
Secondary outcome [4] 352949 0
Participants' level of satisfaction with cognitive remediation program

Assessed by:

Patient Experiences Questionnaire (PEQ)

Timepoint [4] 352949 0
1. Two months post baseline
Secondary outcome [5] 353001 0
Self esteem

Assessed by:

Rosenburg Self Esteem Scale (RSE; 10 item self=report scale for self esteem); total score.
Timepoint [5] 353001 0
1. Baseline (service entry)
2. Two months post service entry
3. Six months post service entry
Secondary outcome [6] 353002 0
Quality of life

Assessed by:

WHO Quality of Life - 8 item (EUROHIS-QoL-8; eight item self report scale on quality of life)
Timepoint [6] 353002 0
1. Baseline (service entry)
2. Two months post service entry
3. Six months post service entry
Secondary outcome [7] 353003 0
Staff level of satisfaction with cognitive remediation program

Assessed by:

Staff focus groups (qualitative data; anonymous verbatim recording and thematic analysis)
Timepoint [7] 353003 0
1. In the two weeks prior to commencement of cognitive remediation program, when training has been completed
2. Six months after commencement of cognitive remediation program.

Eligibility
Key inclusion criteria
All residents at Wattlegrove residential rehabilitation facility during the period of the trial.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide informed consent, due to:

a) Inadequate level of English to understand information sheet and consent forms
b) Severe cognitive impairment, as assessed by the Brief Assessment of Cognition (BAC; total score in severe range)
c) active psychosis requiring referral to acute psychiatric treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
N/A
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
Sample size calculations use G*Power 3.1. We anticipate a medium effect size (effect size f=.4). based on previous studies. We set power to 0.95 and a to .05. With these parameters, we require 42 cases per group, or a total sample of 84. We predict a 20% attrition rate and therefore plan to recruit a total of 100 participants. With 42 people in each group, we will have 95% power to detect medium effects for the planned two group comparisons. Nevertheless, all participants will be included in the intent-to-treat analysis.

Data analysis will include frequency analyses of demographic characteristics, outcome measures, feasibility data and client/worker satisfaction data. The independent variable is treatment condition, with 2 levels: (i) CR program + standard care; (ii) Standard care only. The primary outcome variables are cognitive functioning (BAC, SCORS, WCST). The secondary outcomes are degree of substance dependence (SDS), psychological distress (K10), self-efficacy (RSES) and wellbeing (WHO QoL-8).

Preliminary statistical analyses will be undertaken to check for baseline group differences on demographic, primary and secondary outcome variables using one-way analysis of variance and chi-square (?2) analyses. Intent-to-treat strategies will be used for the main analyses. To determine whether there are group differences on the primary and secondary outcome measures at 6 month follow-up, a series of mixed effects model repeated measures analyses of variance (MMRM) will be employed. The within groups factor will be time (baseline, 2 months and 6 months) and group will serve as the between-subjects factor. This technique can also control for potential confounding variables such as sex and age. Level of pre-morbid cognitive functioning and length of stay at Wattlegrove will be treated as covariates.

Recruitment
Recruitment status
Recruiting
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)
NSW
Recruitment postcode(s) [1] 24359 0
2800 - Orange

Funding & Sponsors
Funding source category [1] 300950 0
Government body
Name [1] 300950 0
NSW Ministry of Health NGO Evaluation Grant
Address [1] 300950 0
NSW Ministry of Health
73 Miller St
North Sydney NSW 2060
Country [1] 300950 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Lives Lived Well
Address
Level 1/55 Little Edward St
Spring Hill Qld 4000
Country
Australia
Secondary sponsor category [1] 300523 0
University
Name [1] 300523 0
School of Psychology, University of Queensland
Address [1] 300523 0
School of Psychology
University of Queensland
St Lucia QLD 4072
Country [1] 300523 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301718 0
University of Queensland Human Research Ethics Committee
Ethics committee address [1] 301718 0
University of Queensland
St Lucia QLD 4072
Ethics committee country [1] 301718 0
Australia
Date submitted for ethics approval [1] 301718 0
09/10/2018
Approval date [1] 301718 0
29/11/2018
Ethics approval number [1] 301718 0
2018002083

Summary
Brief summary
People in treatment for substance use disorders have high rates of cognitive impairment. Problematic substance use is likely to be both a cause and an effect of cognitive impairment. Cognitive Remediation (CR) has been shown to improve cognitive functioning in other clinical populations but is rarely available in Alcohol and Other Drug (AOD) treatment settings. We will add a CR program to an existing AOD residential rehabilitation program and evaluate its effectiveness and feasibility in this setting.

Participants are residents of Wattlegrove, a 3-month residential AOD rehabilitation program in Orange NSW. We will compare standard care with standard care + CR with a non-randomised allocation. The CR intervention will follow the Neuropsychological Educational Approach to Cognitive Remediation (NEAR; Medalia et al, 2009, 2017) and will involve three, hour-long group sessions per week for the duration of treatment. Each group session involves participants working through an individualised program of computerised CR exercises and a manualised group intervention which aims to link the computerised exercises with real life tasks.

We aim to determine: (1) whether CR results in better cognitive, AOD, mental health, wellbeing and functional outcomes than standard care, and (2) the feasibility and costs of implementing a cognitive remediation program in a residential rehabilitation setting, for possible future incorporation into routine care at Wattlegrove and other AOD rehabilitation facilities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87870 0
Dr Julaine Allan
Address 87870 0
Lives Lived Well NSW
91 Dalton St
Orange NSW 2800
Country 87870 0
Australia
Phone 87870 0
+61 437 869 033
Fax 87870 0
Email 87870 0
Julaine.Allan@liveslivedwell.org.au
Contact person for public queries
Name 87871 0
Dr Anna Thompson
Address 87871 0
Lives Lived Well NSW
91 Dalton St
Orange NSW 2800
Country 87871 0
Australia
Phone 87871 0
+61 427 143 579
Fax 87871 0
Email 87871 0
Anna.Thompson@liveslivedwell.org.au
Contact person for scientific queries
Name 87872 0
Prof Leanne Hides
Address 87872 0
School of Psychology
University of Queensland
Sir Fred Schonell Dr
St Lucia QLD 4072
Country 87872 0
Australia
Phone 87872 0
+61 7 336 56398
Fax 87872 0
Email 87872 0
l.hides@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidential individual participant data will not be publicly available however general feedback will be provided to participants as part of treatment in the CR condition and on request in the control condition.
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable