Table 5.
Study timeline and measures.
| R |
||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Activity/measure | Baseline [2 weeks] | Study week (from randomisation) |
||||||||||||
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | ||
| Screening/enrolment | X | |||||||||||||
| Assessment | X | |||||||||||||
| Cocaine cue-induction | X | |||||||||||||
| MFCT | X | |||||||||||||
| DSM-5 | X | X | ||||||||||||
| ADAPT | X | X | ||||||||||||
| CEQ-F | X | X | X | |||||||||||
| CEQ-S | X | |||||||||||||
| TOP (PDA) | X | X | X | |||||||||||
| TOP (LCA) | X | X | ||||||||||||
| UDS | X | X | X | |||||||||||
| DERS | X | X | ||||||||||||
| HR | X | |||||||||||||
| (HRV) LF | X | |||||||||||||
| (HRV) HF | X | |||||||||||||
| (HRV) LF/HF | X | |||||||||||||
| (HRV) rMSSD | X | |||||||||||||
| EDA | X | |||||||||||||
| Adverse events form | X | X | X | X | X | X | X | X | X | X | X | X | X | |
| Participant paymentsa | X | X | X | X | X | |||||||||
Note.
R, randomisation.
MFCT, memory-focused cognitive therapy.
ADAPT, Addiction Dimensions for Assessment and Personalised Treatment.
CEQ-F, Craving Experiences Questionnaire (frequency version).
CEQ-S, Craving Experiences Questionnaire (strength version).
TOP, Treatment Outcomes Profile (TOP).
PDA, percentage days abstinent (cocaine).
LPA, longest period of continuous abstinence (days).
UDS, urine drug screen.
DERS, Difficulties in Emotion Regulation Scale.
HR, heart rate.
HRV (heart rate variability).
LF, low frequency power.
HF, high frequency power.
LF/HF, ratio of low frequency to high frequency power.
rMSSD, Root Mean Square of the Successive Differences.
EDA, electrodermal activity.
Participant payments (attendance time offset and using retail store vouchers) according to local recommendations for patient and public involvement [70]: 1-hour assessment session (20 GBP); each attendance at CRF (including 1 h return travel time [50 GBP]; each follow-up (20 GBP).