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Trial registered on ANZCTR


Registration number
ACTRN12618001231235
Ethics application status
Approved
Date submitted
17/07/2018
Date registered
23/07/2018
Date last updated
25/06/2019
Date data sharing statement initially provided
25/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuing Care Project: A randomised controlled trial of a continuing care telephone intervention following residential substance dependence treatment.
Scientific title
Continuing Care Project: A randomised controlled trial examining the effect of a continuing care telephone intervention on substance use following residential substance dependence treatment.
Secondary ID [1] 295587 0
None
Universal Trial Number (UTN)
Trial acronym
CCP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol dependence 308885 0
Substance dependence 308939 0
Condition category
Condition code
Mental Health 307797 307797 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1. 12-session continuing care telephone intervention.
Whilst the person is still attending the residential facility, they will develop a written continuing care plan with the continuing care worker (approximately 1-hour session). This plan involves reviewing the reasons that the participant wants to change their alcohol and/or substance use, identifying and discussing strategies to manage high risk situations, reviewing rewarding activities that the person can engage in once they leave residential treatment, establishing recovery goals, and identifying support people for the participant. Once the person leaves the residential facility they will be offered 12 telephone sessions over a 3-month period. These sessions include a general check in, and a review of risk factors and protective factors for the person. Participants are encouraged to identify and plan for high-risk situations and reflect on and set substance-related goals. These telephone sessions will take between 15 to 30 minutes to complete. The procedures also include offering face-to-face appointments or more frequent telephone contact with participants if they are at significant risk of relapse or adverse events. The continuing care plan and continue care telephone sessions are based on the protocols developed by McKay et al., 2010.

Arm 2. 4-session continuing care telephone intervention.
The 4-session arm consists of the same procedures outlined above (i.e. initial face-to-face session). However, participants will only be offered 4-telephone continuing care sessions over a 1-month period after they leave the residential program.

Intervention delivery: Drug and alcohol workers have been recruited from within The Salvation Army and We Help Ourselves to work as Continuing Care Workers. These people will be based at sites. Training will cover research procedures and role-plays of assessment instrument administration, the initial face-to-face session, additional face-to-face sessions if needed, and telephone treatment sessions. Audiotaped feedback will be used to enhance training. Session checklists will be employed to guide weekly supervision provided by the chief investigators and project coordinator. The training will involve a minimum of 4 face to face full day training sessions. It will be supported by weekly supervision sessions (approximately an hour a week) and simulated role plays of sessions using the telephone. Training will be provided just prior to the commencement of the trial. The training and ongoing supervision will be led by a Clinical Psychologist.

Treatment fidelity: Prior to commencement of the study the Continuing Care Workers and the Research Clinician will be trained to competency in both the assessment and intervention protocols. This will include auditing practice sessions conducted by the clinicians. Once the study commences, all assessment and intervention sessions will be audiotaped. Independent psychologists will rate a random allocation of treatment of sessions for fidelity and competence, and provide feedback to the Continuing Care Workers throughout the study to maintain fidelity. These tapes will also be reviewed within supervision to support adherence.
Intervention code [1] 301885 0
Rehabilitation
Intervention code [2] 301922 0
Treatment: Other
Comparator / control treatment
Arm 3. Continuing care plan only.
Consistent with Arm's 1 and 2, participants in Arm 3 will also develop a written continuing are plan with the continuing care worker whilst they are attending the residential facility. However, they will not complete any of the telephone delivered continuing care sessions.
Control group
Active

Outcomes
Primary outcome [1] 306787 0
The primary outcome will be percentage of days abstinent from alcohol and other drugs (excluding tobacco) over the 28-day period immediately prior to the 6-month follow-up. This will be measured using the Timeline Follow-Back Method.
Timepoint [1] 306787 0
6-months post discharge from residential treatment
Secondary outcome [1] 349652 0
Percentage of days abstinent from alcohol and other drugs (excluding tobacco) over the 28-day period immediately prior to the 3-month follow-up. This will be measured using the Timeline Follow-Back Method.
Timepoint [1] 349652 0
3-months post discharge from residential treatment
Secondary outcome [2] 349762 0
Patient report recovery outcomes using the Substance Use Recovery Evaluator (SURE)
Timepoint [2] 349762 0
3 and 6 months
Secondary outcome [3] 349763 0
Psychological distress using the Kessler-10
Timepoint [3] 349763 0
3 months and 6 months
Secondary outcome [4] 349764 0
Confidence using the Drug Taking Confidence Questionnaire (DTCQ-8)
Timepoint [4] 349764 0
3 months and 6 months
Secondary outcome [5] 349765 0
Quality of Life using the EUROHIS Quality of Life 8-item Index
Timepoint [5] 349765 0
3 months and 6 months
Secondary outcome [6] 349766 0
Physical health using the Short From-12
Timepoint [6] 349766 0
3 months and 6 months
Secondary outcome [7] 349767 0
Health literacy using the the Health Literacy Questionnaire
Timepoint [7] 349767 0
3 months and 6 months
Secondary outcome [8] 349768 0
Involvement in community based services and legal services following residential treatment using the Lifetime Drug Use History questionnaire.
Timepoint [8] 349768 0
3 months and 6 months
Secondary outcome [9] 349769 0
A within trial cost-effectiveness analysis will be based on the relative change, between baseline and six-month post intervention, in the primary outcome variable: percentage days abstinent. This measure will be used for both control and intervention participants who meet the study’s inclusion criteria. A cost model will capture the resources required to deliver the intervention and this will include any intervention-related costs borne by patients. Patient expenses will be recorded at each participant contact point and collected using a modified Client Services Receipt Inventory (CSRI).
Timepoint [9] 349769 0
3 months and 6 months

Eligibility
Key inclusion criteria
Participants will be required to be attending residential services provided by The Salvation Army or We Help Ourselves (WHOS). Participants will be required to: (1) have a substance use disorder (i.e. not be attending the service for only a gambling problem), (2) have stayed in the residential facility for at least 4-weeks, (3). have access to a telephone to complete the intervention when they leave the residential program.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be kept to a minimum to promote the generalizability of the results. Participants will only be excluded from the study if they are (1) currently at risk of suicide or (2) have unstable mental health symptoms.

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)
The eligibility screening, baseline assessment and the continuing care plan will be completed whilst the person is still attending the residential facility. Once the person leaves the facility, central randomisation by computer will be conducted.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible consenting participants will be randomly allocated to Arms 1, 2 or 3 using central computerized randomization. The allocation sequence will be generated using permuted block randomisation (blocks of size 4) by an independent statistician at the Clinical Research Design, IT and Statistical Support (CReDITSS) unit at the Hunter Medical Research Institute. Participants will be stratified based on age (under 25 and over 25) and organisation. This will provide an opportunity to examine the impact of the intervention on young people.
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
A sample of 90 per group will give the study 80% power to detect a 0.3 standardised difference between intervention groups in the change from baseline percentage days abstinent (PDA) at a 5% significance threshold. This calculation assumes a correlation between baseline and follow-up of 0.7. A meta-analysis of continuing care treatment effects for participants with substance abuse disorders identified a pooled treatment of ~0.3SD. A standard deviation of 30% for PDA has been reported elsewhere22, so a 0.3SD difference corresponds to a clinically meaningful difference of 10% between the treatment groups. Based on a conservative follow-up of 75% of participants at 6-months, we will recruit 360 participants to the study to ensure sufficient power.

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] 23469 0
2259 - Dooralong

Funding & Sponsors
Funding source category [1] 300163 0
Government body
Name [1] 300163 0
NSW Health
Address [1] 300163 0
73 Miller Street
North Sydney NSW 2060
Australia
Country [1] 300163 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Peter Kelly
Address
Northfields Avenue
School of Psychology
University of Wollongong
Wollongong, NSW
Australia, 2500
Country
Australia
Secondary sponsor category [1] 299574 0
None
Name [1] 299574 0
Address [1] 299574 0
Country [1] 299574 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300996 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 300996 0
Human Research Ethics Committee
Northfields Avenue
University of Wollongong
Wollongong, NSW
Australia, 2500
Ethics committee country [1] 300996 0
Australia
Date submitted for ethics approval [1] 300996 0
23/03/2018
Approval date [1] 300996 0
22/05/2018
Ethics approval number [1] 300996 0
2018/156

Summary
Brief summary
A priority area in the field of substance abuse treatment is reducing the rates of relapse. Studies in the United States have demonstrated that telephone delivered continuing care interventions are both clinically effective and cost effective when delivered as a component of outpatient treatment. The proposed trial will examine a well-established telephone delivered continuing care intervention for people exiting residential substance abuse treatment. The study will be conducted as a randomised controlled trial, where participants will be randomised to one of three arms: (i) continuing care plan only (, (ii) 4-session continuing care telephone delivered intervention, or (iii) 12-session continuing care telephone delivered intervention. Participants will be attending therapeutic communities provided by either The Salvation Army (Central Coast, Sydney) or We Help Ourselves (Sydney). Outcomes will be compared across the three arms. It is hypothesised that: (i) participants in the continuing care treatment arms will demonstrate significantly higher rates of percentage of days abstinent from alcohol and other drugs (excluding tobacco) at follow-up compared to the control (continuing care plan only) arm and (ii) that participants in the 12-session continuing care arm will demonstrate higher rates of percentage of days abstinent at follow-up compared to the 4-session arm.

It is anticipated that the current study will demonstrate that a continuing care intervention is a relatively low cost clinical intervention that can help to support people following residential care. The study will also provide evidence on the number of telephone sessions required to improve abstinence and other outcomes as part of continuing care interventions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85542 0
A/Prof Peter Kelly
Address 85542 0
Northfields Avenue
School of Psychology
University of Wollongong
Wollongong, NSW,
Australia, 2500
Country 85542 0
Australia
Phone 85542 0
+61 2 4239 2382
Fax 85542 0
Email 85542 0
pkelly@uow.edu.au
Contact person for public queries
Name 85543 0
A/Prof Peter Kelly
Address 85543 0
Northfields Avenue
School of Psychology
University of Wollongong
Wollongong, NSW,
Australia, 2500
Country 85543 0
Australia
Phone 85543 0
+61 2 4239 2382
Fax 85543 0
Email 85543 0
pkelly@uow.edu.au
Contact person for scientific queries
Name 85544 0
A/Prof Peter Kelly
Address 85544 0
Northfields Avenue
School of Psychology
University of Wollongong
Wollongong, NSW,
Australia, 2500
Country 85544 0
Australia
Phone 85544 0
+61 2 4239 2382
Fax 85544 0
Email 85544 0
pkelly@uow.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
We do not currently have ethics approval for this.
What supporting documents are/will be available?
No other documents available
Summary results
No Results