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Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation

ConditionTobacco Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentral Institute of Mental Health, Mannheim

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Factorial

Treatments tested in this trial

  • Standard smoking cessation program (SCP)

    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)

    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)

    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).

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: HIIT morningActive comparator 1 intervention
Group B: HIIT eveningExperimental treatment 2 interventions
Group C: HIIT morning + CRTActive comparator 2 interventions
Group D: HIIT evening + CRTExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Time until first severe relapse

days until the first severe smoking relapse after treatment

Time frame
timepoint 3: follow-up 3 months after end of SCP
2

Percentage of abstinent days

Percentage of abstinent days in the 3 months after treatment

Time frame
timepoint 3: follow-up 3 months after end of SCP
3

Change in smoking urges

questionnaire of smoking urges (QSU, Müller et al. 2001)

Time frame
2 time points: before and after 6 weeks SCP
4

Change in neural measures of response inhibition

SST fMRI task (Gan et al., 2014)

Time frame
2 time points: before and after 6 weeks SCP

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Central Institute of Mental Health, Mannheim

Lead sponsor

Source ClinicalTrials.gov
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