Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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).
• Поведенческое 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).

Первичные конечные точки

• Time until first severe relapse [Срок оценки: timepoint 3: follow-up 3 months after end of SCP]
• Percentage of abstinent days [Срок оценки: timepoint 3: follow-up 3 months after end of SCP]
• Change in smoking urges [Срок оценки: 2 time points: before and after 6 weeks SCP]
• Change in neural measures of response inhibition [Срок оценки: 2 time points: before and after 6 weeks SCP]
• Change in neural measures of working memory [Срок оценки: 2 time points: before and after 6 weeks SCP]
• Change in neural functional connectivity in the salience network [Срок оценки: 2 time points: before and after 6 weeks SCP]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit — Mannheim

Публикации

• 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. PMID 39987116

Идентификаторы

NCT: NCT05726045 · TRR265 C01-P2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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