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Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05726045
Enrollment
140
Registered
2023-02-13
Start date
2024-04-01
Completion date
2026-06-30
Last updated
2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Disorder

Keywords

Addiction, Nicotine, Smoking Cessation, Relapse, Cognitive remediation, Exercise training

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.

Interventions

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.

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).

BEHAVIORALHigh-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).

Sponsors

Central Institute of Mental Health, Mannheim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time until first severe relapsetimepoint 3: follow-up 3 months after end of SCPdays until the first severe smoking relapse after treatment
Percentage of abstinent daystimepoint 3: follow-up 3 months after end of SCPPercentage of abstinent days in the 3 months after treatment
Change in smoking urges2 time points: before and after 6 weeks SCPquestionnaire of smoking urges (QSU, Müller et al. 2001)
Change in neural measures of response inhibition2 time points: before and after 6 weeks SCPSST fMRI task (Gan et al., 2014)
Change in neural measures of working memory2 time points: before and after 6 weeks SCPNback fMRI task (Charlet et al., 2014)
Change in neural functional connectivity in the salience network2 time points: before and after 6 weeks SCPresting state connectivity to seed region right anterior insula

Countries

Germany

Contacts

Primary ContactSabine Vollstädt-Klein, Prof. Dr.
s.vollstaedt-klein@zi-mannheim.de+49-621/1703
Backup ContactGordon Feld, Dr.
gordon.feld@zi-mannheim.de+49-621/1703

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026