Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000424808
Ethics application status
Approved
Date submitted
16/02/2021
Date registered
16/04/2021
Date last updated
27/10/2024
Date data sharing statement initially provided
16/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
MYSS-HYPE: A pilot study of contingency management for smoking cessation in young people with Borderline Personality Disorder features
Scientific title
MYSS-HYPE: A pilot open-label study of the safety and acceptability of contingency management for smoking cessation in young people with Borderline Personality Disorder features
Secondary ID [1] 303486 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cigarette smoking 316776 0
Borderline Personality Disorder features 316777 0
Condition category
Condition code
Mental Health 315002 315002 0 0
Addiction
Mental Health 315003 315003 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will undergo eight weeks of Contingency Management (CM). The CM will incentivise abstinence from cigarette smoking using cash reinforcement. Participants will attend 8 short (15 minute) face to face sessions in which they will report on their past week cigarette smoking and complete a carbon monoxide breath test (using a Smokerlyzer device). Participants submitting CO tests indicative of abstinence will receive a cash reward. The cash reward available at each session will increase with each consecutive week of abstinence, beginning at $25 (Week 1) and increasing in five-dollar increments up to a maximum of $60 (Week 8). Participants who have smoked in the past week will not receive a cash reward in their weekly session; furthermore, the potential reward for abstinence will reset at the starting amount ($25) the following week. In total, participants may receive up to $340 in cash rewards for verified abstinence throughout the trial. Session attendance checklists will be used to monitor adherence to the intervention and research procedures.

Concomitant Therapy

As patients of Orygen Specialist Program, participants will also continue to receive Treatment As Usual (TAU), i.e., standard psychosocial and psychiatric care delivered at the Orygen Specialist Program. TAU may include the opportunity to discuss cigarette smoking cravings and smoking cessation with their treating team (i.e., a mental health clinician and psychiatric registrar/consultant psychiatrist), in addition to a referral to Quitline. Participants may also undergo clinically indicated pharmacotherapy. Participants discharged from the Orygen Specialist Program, and enrolled at the Orygen Primary Services (Orygen Clinical Trials Unit) site will receive TAU at a mental health outpatient service.
Intervention code [1] 317224 0
Behaviour
Comparator / control treatment
No control group (pilot open-label study)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323353 0
Acceptability, as measured by proportion of participants attending more than 50% of CM visits (i.e. at least 5 of 8 visits), assessed from study checklists.
Timepoint [1] 323353 0
At the conclusion of the study.
Primary outcome [2] 323354 0
Safety, as measured by change in Kessler-10 (K10) psychological distress from baseline to week 8.
Timepoint [2] 323354 0
Baseline and Week 8
Secondary outcome [1] 391969 0
Acceptability, as measured by ability to consent 40 participants into the study, assessed via assessment of study records.
Timepoint [1] 391969 0
At the conclusion of the study
Secondary outcome [2] 391970 0
Acceptability, as measured by participant self-report via semi-structured interview.
Timepoint [2] 391970 0
Week 8
Secondary outcome [3] 391971 0
Safety, as measured by change in Deliberate Self-Harm Inventory from baseline to weeks 8 and 16.
Timepoint [3] 391971 0
Baseline, Weeks 8 and 16
Secondary outcome [4] 391972 0
Safety, as measured by change in BPRS suicidality item from baseline to weeks 8 and 16;
Timepoint [4] 391972 0
Baseline, Weeks 8 and 16
Secondary outcome [5] 391973 0
Safety, as measured by change in K-10 psychological distress from baseline to week 16.
Timepoint [5] 391973 0
Baseline and Week 16
Secondary outcome [6] 391974 0
Initial efficacy, as indicated by change in self-reported number of cigarettes smoked daily from baseline to weeks 8 and 16;
Timepoint [6] 391974 0
Baseline, Weeks 8 and 16
Secondary outcome [7] 391975 0
Initial efficacy, as indicated by change in breath Carbon Monoxide from baseline to weeks 8 and 16 measured using Smokerlyzer device.
Timepoint [7] 391975 0
Baseline, Weeks 8 and 16
Secondary outcome [8] 391976 0
Initial efficacy, as indicated by proportion of enrolled participants maintaining cigarette abstinence at weeks 8 and 16 based on criteria adapted from the Russel Standard criteria. Specifically, participants will be rated as abstinent when they provide a CO test <5ppm (measured using Smokerlyzer device), they report on participant self-report forms having remained quit for at least the past month, and they report no slip-ups – not even a puff – in the week before assessment.
Timepoint [8] 391976 0
Weeks 8 and 16

Eligibility
Key inclusion criteria
Aged 15-25 years old (inclusive);
Receiving mental health care at Orygen Specialist Program or other mental health outpatient service;
Presenting with 3 or more BPD features;
Report smoking at least 5 cigarettes per day for at least 5 days per week within the past four weeks, confirmed by a CO > 5ppm on Smokerlyzer;
Fluent in the English language; and
Able to give informed consent and adhere to study procedures.
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have used smoking cessation medications within the last week;
Already engaged with Quitline at the time of consent;
Have a diagnosis of first episode psychosis and/or psychological disturbance such that they will be unable to comply with the study protocol.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We have not used a power calculation as this is a pilot study and our aim is to examine the feasibility of the intervention. We will recruit 40 participants based on the previous HYPE research retention rates of 80%, with 32 participants expected to complete the follow-up assessments.

We will assess the primary acceptability outcome (50% of participants attending >50% of CM visits) using descriptive statistics.

For the safety primary outcome (change in K-10 psychological distress from baseline to week 8) we will employ a repeated-measures t-test. Safety would be supported by either a statistically significant (p<0.05) decrease in K-10 scores, or scores remaining stable (no statistically significant change) over the 8-week period.

A similar approach will be taken to assess the change from baseline to weeks 8 and 16 for the secondary safety measures (DSHI and BPRS suicide item) and the number of cigarettes smoked daily and breath CO levels. Descriptive statistics will be employed to characterise abstinence rates (defined according to the Russel Standard criteria) at 8-week and 16-week follow-up.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/04/2021
Actual
26/04/2021
Date of last participant enrolment
Anticipated
31/12/2022
Actual
9/06/2023
Date of last data collection
Anticipated
30/04/2023
Actual
26/09/2023
Sample size
Target
40
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18736 0
Orygen Youth Health - Parkville - Parkville
Recruitment hospital [2] 18737 0
Orygen Youth Health - Sunshine - Sunshine
Recruitment postcode(s) [1] 33180 0
3052 - Parkville
Recruitment postcode(s) [2] 33181 0
3020 - Sunshine

Funding & Sponsors
Funding source category [1] 305317 0
Hospital
Name [1] 305317 0
Royal Melbourne Hospital North Western Mental Health Research Fund
Country [1] 305317 0
Australia
Funding source category [2] 307905 0
University
Name [2] 307905 0
Faculty of Medicine, Dentistry and Health Sciences Research Grant Support Scheme, University of Melbourne
Country [2] 307905 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Orygen
Address
Orygen
35 Poplar Road
Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 305740 0
None
Name [1] 305740 0
Address [1] 305740 0
Country [1] 305740 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305656 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 305656 0
Ethics committee country [1] 305656 0
Australia
Date submitted for ethics approval [1] 305656 0
Approval date [1] 305656 0
23/08/2019
Ethics approval number [1] 305656 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101110 0
Prof Andrew Chanen
Address 101110 0
Orygen
35 Poplar Road
Parkville, VIC 3052
Country 101110 0
Australia
Phone 101110 0
+61 3 9966 9580
Fax 101110 0
Email 101110 0
[email protected]
Contact person for public queries
Name 101111 0
Andrew Chanen
Address 101111 0
Orygen
35 Poplar Road
Parkville, VIC 3052
Country 101111 0
Australia
Phone 101111 0
+61 3 9966 9580
Fax 101111 0
Email 101111 0
[email protected]
Contact person for scientific queries
Name 101112 0
Andrew Chanen
Address 101112 0
Orygen
35 Poplar Road
Parkville, VIC 3052
Country 101112 0
Australia
Phone 101112 0
+61 3 9966 9580
Fax 101112 0
Email 101112 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data may be shared upon request.

When will data be available (start and end dates)?
Data are available immediately for an indefinite time.
Available to whom?
Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data management policy
Available for what types of analyses?
To any type of analyses. Assessed on a case-by-case basis.
How or where can data be obtained?
Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health). Search for the ANZTRN number in the catalogue to find datasets associated with this trial.


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
No additional documents have been identified.