Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation

Study Overview
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Brief Summary
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The goal of this subproject is to examine the hypothesized improvement of treatment with chess-based training and sleep enhancement, both together and on their own, in smokers. Participants will undergo fMRI measurements, sleep monitoring. They will then be assigned to one of the four experimental groups, including high-intensity interval training with or without chess-based training.

Detailed Description
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This subproject aims to improve treatment outcome in patients with tobacco use disorder (TUD) by enhancing cognitive control. Evidence from the first funding period (1st FP) indicates that enhancing cognitive control using cognitive remediation training (CRT, in our case chess-based) can improve outcomes of a standard smoking cessation program. The current project will harness three means to build on this success of enhancing cognitive control by: 1. using our tried-and-tested chess-based training, 2. improving sleep using high-intensity interval training (HIIT), 3. increasing sleep-dependent consolidation of the chess-based training (see Figure 1). We hypothesize that chess-based training and sleep enhance treatment outcome, both together and on their own. To test our hypotheses, we will combine smoking cessation treatment with the aforementioned approaches as app-based add-ons (chess-based training and HIIT). This will not only allow us to apply the training in a cost-efficient way out-side the lab, it may also increase patients' compliance.

Official Title
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Increasing the Smoking Cessation Success Rate by Enhancing Improvement of Self-control Through Sleep-amplified Memory Consolidation

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Behavioral: Standard smoking cessation program (SCP)
* Behavioral: Cognitive remediation treatment (CRT)
* Behavioral: High-intensity interval training (HIIT evening)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe tobacco use disorder (TUD) according to DSM-5 sufficient ability to communicate with investigators and answer questions in both written and verbal format ability to provide fully informed consent and to use self-rating scales right-handedness HIIT can be performed without the risk of side effect (medical sports check) Exclusion Criteria: severe internal, neurological, and/or psychiatric comorbidities; other Axis I mental disorders other than TUD according to ICD-10 and DSM 5 (except for mild depression, i.e. F32.0, adjustment disorder and specific phobias) in the last 12 months history of brain injury severe physical diseases common exclusion criteria for MRI (e.g. metal, claustrophobia) positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines) psychotropic medication within the last 14 days pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIIT morning<br>High-intensity interval training (HIIT) in the morning | Behavioral: Standard smoking cessation program (SCP)<br>* Each subject will receive a standard SCP as group treatment once a week (1h) over six weeks. This group therapy is based on behavioural therapy and a psycho-educational approach (for more details see Batra & Buchkremer, 2004), and will be carried out by a qualified therapist.<br>|
| Experimental: HIIT evening<br>High-intensity interval training (HIIT) in the evening | Behavioral: Standard smoking cessation program (SCP)<br>* Each subject will receive a standard SCP as group treatment once a week (1h) over six weeks. This group therapy is based on behavioural therapy and a psycho-educational approach (for more details see Batra & Buchkremer, 2004), and will be carried out by a qualified therapist.<br>Behavioral: High-intensity interval training (HIIT evening)<br>* The high-intensity interval training will be delivered through an app environment with several choices of exercise, two times per week over six weeks. The training will include a 5-minutes warm-up and cool down phase. In between, participants will perform four 4-minutes blocks of exercise at high intensity, interspersed with three 3-minute blocks of low intensity (total of 35 minutes exercise).<br>|
| Active Comparator: HIIT morning + CRT<br>High-intensity interval training (HIIT) in the morning + cognitive remediation treatment (CRT) | Behavioral: Standard smoking cessation program (SCP)<br>* Each subject will receive a standard SCP as group treatment once a week (1h) over six weeks. This group therapy is based on behavioural therapy and a psycho-educational approach (for more details see Batra & Buchkremer, 2004), and will be carried out by a qualified therapist.<br>Behavioral: Cognitive remediation treatment (CRT)<br>* The cognitive remediation treatment (CRT) employs a chess-based battery of tasks (delivered through an app-based online tool), two times per week over six weeks (60min duration per session).<br>|
| Experimental: HIIT evening + CRT<br>High-intensity interval training (HIIT) in the evening+ cognitive remediation treatment (CRT) | Behavioral: Standard smoking cessation program (SCP)<br>* Each subject will receive a standard SCP as group treatment once a week (1h) over six weeks. This group therapy is based on behavioural therapy and a psycho-educational approach (for more details see Batra & Buchkremer, 2004), and will be carried out by a qualified therapist.<br>Behavioral: Cognitive remediation treatment (CRT)<br>* The cognitive remediation treatment (CRT) employs a chess-based battery of tasks (delivered through an app-based online tool), two times per week over six weeks (60min duration per session).<br>Behavioral: High-intensity interval training (HIIT evening)<br>* The high-intensity interval training will be delivered through an app environment with several choices of exercise, two times per week over six weeks. The training will include a 5-minutes warm-up and cool down phase. In between, participants will perform four 4-minutes blocks of exercise at high intensity, interspersed with three 3-minute blocks of low intensity (total of 35 minutes exercise).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until first severe relapse | days until the first severe smoking relapse after treatment | timepoint 3: follow-up 3 months after end of SCP | 
| Percentage of abstinent days | Percentage of abstinent days in the 3 months after treatment | timepoint 3: follow-up 3 months after end of SCP | 
| Change in smoking urges | questionnaire of smoking urges (QSU, Müller et al. 2001) | 2 time points: before and after 6 weeks SCP | 
| Change in neural measures of response inhibition | SST fMRI task (Gan et al., 2014) | 2 time points: before and after 6 weeks SCP | 
| Change in neural measures of working memory | Nback fMRI task (Charlet et al., 2014) | 2 time points: before and after 6 weeks SCP | 
| Change in neural functional connectivity in the salience network | resting state connectivity to seed region right anterior insula | 2 time points: before and after 6 weeks SCP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Addiction, Nicotine, Smoking Cessation, Relapse, Cognitive remediation, Exercise training