The CanCope Study is a micro-randomized trial conducted to gather evidence about and compare the effectiveness of a momentary intervention to help young adults cope with cannabis cravings as they attempt to reduce their use.

CanCope: Digital Intervention for Coping With Cannabis Craving

Cannabis Use

The CanCope Study is designed to test the effectiveness of two distinct strategies (mindfulness and distraction) to cope with cannabis cravings in young adults (19 - 25 years) who are attempting to reduce their cannabis use. Cannabis use is determined using a single-item question about the number of days out of the past 30 days the individual used cannabis. Young adults who reported using cannabis >10 out of the past 30 days, who were not pregnant or breastfeeding, and who were not currently in treatment for problems related to substance use were eligible to enroll in this four-week study.

The CanCope intervention was delivered to participants through the MetricWire app, which was available for download on the participants' personal smartphones. Participants were asked to complete five ecological momentary assessments (EMA) per day, which asked questions related to cannabis use including one question about current level of craving on a scale of 0 - 10. If a participant reported a craving level >4, a message was sent via the app encouraging the participant to try a mindfulness or distraction coping strategy, or the participant received a thank-you for completing the EMA which served as an attention control.

CanCope

Participants were asked to rate their level of cannabis craving on a scale of 0 - 10 five times per day where higher scores indicate more craving. Participants were considered available for randomization when craving >=4 and they clicked the intervention message in the study app. To determine the effect of messaging on craving, we will calculate the average craving level for each EMA eligible for intervention and randomized to receive an active coping strategy message or a control message. It was pre-specified based on a priori power analyses for this small pilot study to combine the "mindfulness-based coping strategies" and "distraction-based coping strategies" interventions in the "Active Message" Row". Craving levels will be averaged across randomized observations. There were up to 140 decision points (5 EMAs per day x 28 days) per participant for the intervention period.

The CanCope intervention was delivered through the MetricWire app which was available to each participant on their personal smartphone. The intervention included a "push" component which was responsive to a participant's level of craving (based on self-report assessed via EMA) and sent messages to each participant via the MetricWire app according to a decision rule. MetricWire randomized delivery of the push component with a probability of 0.33 for receiving a mindfulness coping strategy, 0.33 for receiving a distraction coping strategy, and 0.33 for receiving a thank-you message (attention control) at each decision point when participants were available for the intervention.

Center for Technology and Behavioral Health

Data about adverse events collected non-systematically (participant report).

The CanCope intervention was delivered through the MetricWire app which was available to each participant on their personal smartphone. The intervention included a "push" component which was responsive to a participant's level of craving (based on self-report assessed via EMA) and sent messages to each participant via the MetricWire app according to a decision rule. MetricWire randomized delivery of the push component with a probability of 0.33 for receiving a mindfulness coping strategy, 0.33 for receiving a distraction coping strategy, and 0.33 for receiving a thank-you message (attention control) at each decision point when participants were available for the intervention.

CanCope: Messages prompted participants to use mindfulness-based or distraction-based coping strategies, or a thank-you message which served as an attention control. If participants reported elevated craving (4 or greater) prior to a decision point, they received either a coping strategy message or a control message. If participants reported craving levels of less than 4 they received a control message.

CanCope Intervention

Age, Continuous

Gender

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Participants who consented in the app but then failed to complete screening/baseline measures or any EMA assessments were not enrolled. EMA completion was required to randomize individual decision points (completed EMAs) to an intervention in this study design. N= 53 were enrolled based on these criteria.

Catherine Stanger

Control Message

Active Message

Participants were asked to rate their level of cannabis craving on a scale of 0 - 10 five times per day where higher scores indicate more craving. Participants were considered available for randomization when craving \>=4 and they clicked the intervention message in the study app. To determine the effect of messaging on craving, we will calculate the average craving level for each EMA eligible for intervention and randomized to receive an active coping strategy message or a control message. It was pre-specified based on a priori power analyses for this small pilot study to combine the "mindfulness-based coping strategies" and "distraction-based coping strategies" interventions in the "Active Message" Row". Craving levels will be averaged across randomized observations. There were up to 140 decision points (5 EMAs per day x 28 days) per participant for the intervention period.

The CanCope intervention was delivered through the MetricWire app which was available to each participant on their personal smartphone. The intervention included a "push" component which was responsive to a participant's level of craving (based on self-report assessed via EMA) and sent messages to each participant via the MetricWire app according to a decision rule. MetricWire randomized delivery of the push component with a probability of 0.67 for receiving an active message (either a mindfulness or a distraction coping strategy), and 0.33 for receiving a thank-you message (attention control) at each decision point when participants were available for the intervention.

CanCope: Active Messages prompted participants to use mindfulness-based or distraction-based coping strategies, or a thank-you message which served as an attention control. If participants reported elevated craving (4 or greater) and clicked the intervention message, they received either an active coping strategy message or a control message. If participants reported craving levels of less than 4 they received a control message. It was pre-specified to combine the "mindfulness-based coping strategies" and "distraction-based coping strategies" interventions in the "Active Message" category for primary analyses. The study was powered a priori to detect differences in active vs. control messages.

Only participants who completed baseline measures and at least one ecological momentary assessment (EMA) are included in the analyses. Two participants who completed baseline measures did not complete any EMAs which were required for micro-randomization and are therefore not included in the analyses.

CanCope: Digital Intervention for Coping With Cannabis Craving

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?