Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation

NCT ID: NCT05726045

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-06-30

Brief Summary

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

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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIIT morning

High-intensity interval training (HIIT) in the morning

Group Type: ACTIVE_COMPARATOR

Standard smoking cessation program (SCP)

Intervention Type: BEHAVIORAL

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.

HIIT evening

High-intensity interval training (HIIT) in the evening

Group Type: EXPERIMENTAL

Standard smoking cessation program (SCP)

Intervention Type: BEHAVIORAL

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.

High-intensity interval training (HIIT evening)

Intervention Type: BEHAVIORAL

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).

HIIT morning + CRT

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

Group Type: ACTIVE_COMPARATOR

Standard smoking cessation program (SCP)

Intervention Type: BEHAVIORAL

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.

Cognitive remediation treatment (CRT)

Intervention Type: BEHAVIORAL

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).

HIIT evening + CRT

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

Group Type: EXPERIMENTAL

Standard smoking cessation program (SCP)

Intervention Type: BEHAVIORAL

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.

Cognitive remediation treatment (CRT)

Intervention Type: BEHAVIORAL

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).

High-intensity interval training (HIIT evening)

Intervention Type: BEHAVIORAL

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).

Interventions

Standard smoking cessation program (SCP)

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.

Intervention Type: BEHAVIORAL

Cognitive remediation treatment (CRT)

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).

Intervention Type: BEHAVIORAL

High-intensity interval training (HIIT evening)

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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
• positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines)
• psychotropic medication within the last 14 days
• pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabine Vollstädt-Klein, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health, Mannheim

Gordon Feld, Dr.

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health, Mannheim

Karen Ersche, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health, Mannheim

Locations

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Sabine Vollstädt-Klein, Prof. Dr.

Role: CONTACT

s.vollstaedt-klein@zi-mannheim.de

+49-621/1703 ext. 3912

Gordon Feld, Dr.

Role: CONTACT

gordon.feld@zi-mannheim.de

+49-621/1703 ext. 6540

Facility Contacts

Sabine Vollstädt-Klein, Prof. Dr.

Role: primary

s.vollstaedt-klein@zi-mannheim.de

References

Gerhardt S, Kroth M, Seeger A, Schmitt R, Fritz H, Diring L, Shevchenko Y, Ersche KD, Feld G, Vollstadt-Klein S. Increasing the smoking cessation success rate by enhancing improvement of self-control through sleep-amplified memory consolidation: protocol of a randomized controlled, functional magnetic resonance study. BMC Psychol. 2025 Feb 22;13(1):157. doi: 10.1186/s40359-025-02482-w.

Reference Type: DERIVED

PMID: 39987116 (View on PubMed)

Other Identifiers

TRR265 C01-P2

Identifier Type: -

Identifier Source: org_study_id