Cocaine substance use, accessing treatment Mental and Behavioural Disorders
Conditions
Interventions
Participants will be randomised using an online web-based platform into one of two arms: VR-CET or VR-Relaxation. Both will include the same number of meetings
the difference will be the type of scenarios experienced in VR. At the first meeting, participants will be randomised, demographic information collected, and baseline questionnaires completed. Then th
Sponsors
King's College London
South London and Maudsley NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Treatment-seeking patients for cocaine SUD 2. Able and willing to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Evidence of severe mental illness or cognitive impairment 2. Impaired vision or hearing that cannot be corrected (i.e. with contact lenses, glasses or hearing aid) 3. Physical inability to wear a wrist device 4. Both arms having tattoo sleeves (as the device requires contact with ink-free skin) 5. Current participation in a similar research study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: Recruitment rate (participants/month and screen-to-consent), randomisation and intervention uptake (proportion consented who are randomised; proportion randomised who attend =1 VR session), intervention delivery/adherence (sessions attended; proportion attending =4/6 sessions), and retention at 8-week follow-up (proportion completing follow-up) between weeks 1 and 8 measured using study data at one time point;Cocaine use, including frequency of use, cocaine-free days, proportion abstinent, and time to first use, measured using self-reported cocaine use on the Timeline Followback over 28 days (TLFB-28) survey at baseline and 8 weeks follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability of VR interventions (VR-CET and VR Relaxation) measured using an interview at the VR meeting 6 (Week 3 or 4) and post-wear survey at Week 8;Just-in-time adaptive ecological momentary assessment (JITA-EMA) performance measured using trigger frequency, response rate within 1 hour, and proportion of triggers associated with participant-confirmed craving episodes (all tracked by the RADAR active RMT smartphone application) throughout participation, at baseline to Week 8;Data completeness measured using wearable wear time, EMA completion rate, and exit interviews throughout participation at baseline to Week 8;Safety/tolerability measured using adverse event recording, cybersickness, distress episodes and their management throughout participation at baseline to Week 8;Implementation outcomes (service-provider perspective): barriers/facilitators and training and resource needs measured using a semi-structured interview at one time point at the time of staff interview;Resource use measured using staff time, room/space requirements, and equipment set-up/maintenance (to inform a future economic evaluation) throughout data collection at baseline to Week 8;Cue reactivity from baseline to the end of treatment measured using the CEQ-S and wearable-derived physiological data (Empatica Embrace Plus) at baseline (VR meeting 1) and VR meeting 6;Variance in self-reported cocaine use (frequency) across the study period to inform outcome selection and sample size for a future efficacy RCT measured using JITA-EMA (RADAR active RMT smartphone application) throughout participation at baseline to Week 8;Relationships between cue reactivity (and wearable/EMA indices of craving/risk states) and subsequent cocaine use measured using the CEQ-S and wearable-derived physiological data (Empatica Embrace Plus) throughout participation at baseline to Week 8 | — |
Countries
England, United Kingdom
Contacts
Public ContactEileen Brobbin
Outcome results
None listed