Data

MYSS-HYPE: A pilot study of contingency management for smoking cessation in young people with Borderline Personality Disorder features

Orygen Youth Health

Dataset description

The dataset consists of multiple key variables related to an open-label pilot study examining Contingency Management (CM) for smoking cessation in individuals with Borderline Personality Disorder (BPD) features. The variables include participant demographics (e.g., age, gender), session attendance records across eight weekly interventions, and results from carbon monoxide breath tests that measure smoking abstinence. Additionally, it captures financial reward amounts, detailing weekly cash incentives linked to abstinence verification, and adherence tracking to the CM protocol. The dataset also includes variables related to concurrent Treatment As Usual (TAU), documenting psychosocial care, psychiatric treatments, referrals to Quitline, and any pharmacotherapy prescribed during the intervention. Follow-up data at 8 weeks and 16 weeks, such as smoking status and adherence, are also present. No control group data is included, as this was an uncontrolled pilot study.
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Subjects

FOR: Mental Health |

Source Study

Purpose

Treatment

Phase

Not Applicable

Funding

Hospital,Royal Melbourne Hospital North Western Mental Health Research Fund

Scientific enquiries

Prof Andrew Chanen

Brief Summary

The aim of this pilot study is to investigate whether Contingency Management (CM) is acceptable and safe as an intervention for smoking cessation in young people with Borderline Personality Disorder (BPD) features. Existing patients of Orygen's HYPE clinic (N=40) between the ages of 15 and 25 (inclusive) will receive eight weekly sessions of CM in an open-label pilot study, with assessments at baseline, week 8, and follow-up at 16 weeks. The primary hypotheses are that CM will be an acceptable a ....
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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.

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.

Can healthy volunteers participate?

No

 

Population

Sample Size    11

Min. age    15 Years

Max. age    25 Years

Sex    Both males and females

Condition category    Borderline Personality Disorder features , Cigarette smoking

Condition code    Mental Health

Intervention

Intervention code Behaviour

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 increa ....
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Comparison

Control group Uncontrolled

No control group (pilot open-label study)

Outcomes

Outcome: 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: At the conclusion of the study.

Outcome: Safety, as measured by change in Kessler-10 (K10) psychological distress from baseline to week 8.
Timepoint: Baseline and Week 8

Study Protocol: Not Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

Individual participant data may be shared upon request.

When will data be available?

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.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au