Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation

Central Institute of Mental Health, Mannheim

Status: Enrolling

Conditions: Tobacco Use Disorder

Treatments: Behavioral: High-intensity interval training (HIIT evening); Behavioral: Cognitive remediation treatment (CRT); Behavioral: Standard smoking cessation program (SCP)

Study type: Interventional

Funder types: Other

Identifiers

NCT05726045

TRR265 C01-P2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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140 participants in 4 patient groups

HIIT morning

Active Comparator group

Description:

High-intensity interval training (HIIT) in the morning

Treatment:

Behavioral: Standard smoking cessation program (SCP)

HIIT evening

Experimental group

Description:

High-intensity interval training (HIIT) in the evening

Treatment:

Behavioral: Standard smoking cessation program (SCP)

Behavioral: High-intensity interval training (HIIT evening)

HIIT morning + CRT

Active Comparator group

Description:

High-intensity interval training (HIIT) in the morning + cognitive remediation treatment (CRT)

Treatment:

Behavioral: Standard smoking cessation program (SCP)

Behavioral: Cognitive remediation treatment (CRT)

HIIT evening + CRT

Experimental group

Description:

High-intensity interval training (HIIT) in the evening+ cognitive remediation treatment (CRT)

Treatment:

Behavioral: Standard smoking cessation program (SCP)

Behavioral: Cognitive remediation treatment (CRT)

Behavioral: High-intensity interval training (HIIT evening)