NCT02153749

Effects of Brief Training on Craving Regulation

Regulation of Craving: Brief Neurocognitive Training and Neural Mechanisms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose that brief training in regulation of craving may increase the efficacy of smoking cessation, but that training in cognitive vs. mindfulness-based strategies may operate via different psychological and neural mechanisms.

Detailed description

The investigators propose to test the efficacy of such training by randomizing 126 cigarette smokers to the following conditions: 1) brief training in cognitive regulation of craving 2) mindfulness-based training, and 3) control or no training. Training will be delivered in 6x1 hour computerized sessions over four weeks. Control subjects simply fill out assessments during their visits. Participants who were randomized into the cognitive or mindfulness training complete Regulation of Craving (ROC) training sessions of approximately 60-90 minutes. If randomized into the cognitive regulation training, subjects will be trained to use a cognitive strategy that instructs them to think of all the negative outcomes associated with continued cigarette smoking. If randomized into the MBT-based regulation training, subjects will be trained to use a mindfulness strategy that instructs them to notice and accept their feelings of craving without judgment or intent to act upon them. After all training sessions are completed, there is a 4 week and 12 week follow-up. The investigators will evaluate the effects of training on craving and regulation of craving measured by self-report and functional magnetic resonance imaging during the Regulation of Craving(ROC) task administered pre- and post- treatment, as well as smoking.

Conditions

• Nicotine Addiction

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Regulation of Craving	Regulation strategy practice: Participants will be trained to use a CBT-based cognitive regulation strategy. They will be asked to think of their individualized negative consequences for and thing of them when they see the instruction "LATER" during the task. Participants will practice using this strategy for multiple cigarette stimuli. High-Risk Situation Practice: Participants will identify 10 situations in which they usually smoke, or are likely to smoke in the next 48 hours. For each situation, they will be asked to practice using the strategy and to plan to use this strategy to regulate craving in daily life.
BEHAVIORAL	Mindfulness-Based Regulation of Craving	Each training session in this condition will be identical to the CBT-based training session described, with the exception of the strategy being trained. Specifically, participants will be trained in using the MBT-based strategy ("notice craving and accept the feeling without judgment or reaction"). To do so, they will be asked to generate their own non- reactive responses to craving (e.g., "I can just sit here and notice this. I can ask myself, 'can I be ok with this feeling?'") Participants will then be instructed to think of those accepting and non-reactive responses when they see the instruction "ACCEPT" during the task. All other components will be identical.

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2014-06-03
• Last updated: 2020-04-13

Locations

1 site across 1 country: United States