Tobacco Retraining of Automatic Approach to Treat Individuals With Tobacco Dependence and Severe Concurrent Disorders.

Study Overview
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Brief Summary
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A randomized control trial evaluating a novel smoking cessation intervention in individuals at a an inpatient clinic for clients with addiction and concurrent disorders. The intervention is based on cognitive bias modification, where participants are explicitly or implicitly trained to make avoidance movements by pushing a joystick in response to pictures of smoking, and as a result altering their cognitive biases towards smoking and tobacco dependence. Hypothesis: Participation in the experimental (tobacco-avoidance) condition will induce reduction of smoking, assessed as lower levels of carbon monoxide measured at baseline and 12 week follow-up.

Official Title
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Studying a Novel Intervention, the Tobacco Retraining of Automatic Approach (TRAA), to Treat Individuals With Tobacco Dependence and Severe Concurrent Disorders

Conditions
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Tobacco Retraining of Automatic Approach, Placebo Task

Intervention / Treatment
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* Behavioral: TRAA intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Proficiency to read and write english A minimum score of 5 or higher on the fagerström test for nicotine dependence, indicating a medium dependence Current smoking will be validated by Carbon monoxide breath monitor Exclusion Criteria: Patients not yet stabilized enough to allow for regular participation in the intervention

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TRAA<br>participants will be given the active TRAA intervention where landscape images are linked with a push motion, and portrait images linked with a pull motion. Pictures will exclusively be related to smoking. | Behavioral: TRAA intervention<br>* The Tobacco Retraining of Automatic Approach The tobacco-RAA will be the intervention in changing approach tendencies towards tobacco. The task uses pictures of tobacco related objects (e.g, a cigarette) and pictures of non-tobacco related objects (e.g, a spoon). Patients will be presented with a joystick while pictures are presented on a computer screen. Patients will be presented with pictures, pulling pictures in a portrait format, while they push pictures in a landscape format. In the experimental condition pictures pushed will almost exclusively be smoking related pictures. In the control condition smoking pictures will be equally divided into push and pull conditions.<br>|
| Placebo Comparator: Control<br>participants will be given a mix of landscape and portrait pictures, equally divided into push or pull. the images will be a mix of smoking related pictures and non smoking pictures. | Behavioral: TRAA intervention<br>* The Tobacco Retraining of Automatic Approach The tobacco-RAA will be the intervention in changing approach tendencies towards tobacco. The task uses pictures of tobacco related objects (e.g, a cigarette) and pictures of non-tobacco related objects (e.g, a spoon). Patients will be presented with a joystick while pictures are presented on a computer screen. Patients will be presented with pictures, pulling pictures in a portrait format, while they push pictures in a landscape format. In the experimental condition pictures pushed will almost exclusively be smoking related pictures. In the control condition smoking pictures will be equally divided into push and pull conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbon monoxide levels in breath | The breath carbon monoxide monitoring device will be used both before the intervention for a baseline measure and at the 12-week follow-up for comparison. These two measurements will be used to detect changes in smoking patterns that may have occurred during this interval. The method allows to objectify abstinence from smoking. | baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fagerström test for Nicotine dependence (FTND) | The FTND is a 6-item questionnaire scored to test level of nicotine dependence, and will be presented to patients prior to the intervention. Patients meeting a cut-off score of 5 or higher will be eligible to participate in the intervention portion of this study. | Baseline |