Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation

Sponsor

Central Institute of Mental Health, Mannheim (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05726045

Collaborator

(none)

140

Enrollment

Location

Arms

29.9

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Disorder	Behavioral: Standard smoking cessation program (SCP) Behavioral: Cognitive remediation treatment (CRT) Behavioral: High-intensity interval training (HIIT evening)	N/A

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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jun 30, 2026

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: HIIT morning High-intensity interval training (HIIT) in the morning	Behavioral: 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.
Experimental: HIIT evening High-intensity interval training (HIIT) in the evening	Behavioral: 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. 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).
Active Comparator: HIIT morning + CRT High-intensity interval training (HIIT) in the morning + cognitive remediation treatment (CRT)	Behavioral: 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. 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).
Experimental: HIIT evening + CRT High-intensity interval training (HIIT) in the evening+ cognitive remediation treatment (CRT)	Behavioral: 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. 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). 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).

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit	Mannheim	Baden-Württemberg	Germany	68159

Sponsors and Collaborators

Central Institute of Mental Health, Mannheim

Investigators

Principal Investigator: Sabine Vollstädt-Klein, Prof. Dr., Central Institute of Mental Health, Mannheim
Principal Investigator: Gordon Feld, Dr., Central Institute of Mental Health, Mannheim
Principal Investigator: Karen Ersche, Prof. Dr., Central Institute of Mental Health, Mannheim