- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04057534
Neurobiological Mechanisms of Chess as an Add-On Treatment Against SUD (Chess_SUD)
Investigating Neurobiological Mechanisms of Chess as an Add-On Treatment Against Substance Use Disorder
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Mannheim, Germany
- Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- severe alcohol (AUD) or tabacco use disorder (SUD) according to DSM-5
- abstinence from alcohol for at least 72 hours (AUD)
- 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
- main diagnosis AUD: inpatient or outpatient treatment in our clinic
- main diagnosis TUD: participation in 6 weeks smoking cessation treatment
- Normal or corrected to normal vision
- Signed consents for data security
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 other substance use disorders - if AUD or TUD is still the main diagnosis -, ADHD, remitted depression, mild or moderate depression, adjustment disorder, generalized anxiety disorder, phobias, panic disorder or other mild or moderate personality disorders) in the last 12 months
- Severe withdrawal symptoms (CIWA-Ar > 7; Sullivan et al. 1989)
- alcohol intoxication (>0‰)
- history of brain injury
- severe cognitive impairments
- common exclusion criteria for MRI (e.g. metal, claustrophobia, pregnancy)
- suicidality or endangerment of others
- positive Covid-19 screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CB-CRT AUD group
experimental group AUD: patients receive standard clinical therapy and an add-on chess based - cognitive remediation treatment (CB-CRT)
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Behavioral: standard AUD Cognitive Behavioral Therapy (CBT) in Clinical setting. Patients who voluntarily submit to enter a qualified detoxification treatment program will be examined, either in-patient, out-patient, or in a day-clinic setting at the Department of Addictive Behaviour and Addiction Medicine. Additional, the experimental group receives chess based cognitive remediation treatment (CB-CRT) for 1,5 hours three times a week. The tasks of the treatment were created by our cooperation partner, the psychologist Juan Antonio Montero. He is currently successfully applying this battery as an add-on therapy. The training battery is designed to strengthen cognitive functioning in specific domains such as short-term memory, focal attention, selective attention, pattern recognition, visuospatial abilities, metacognition and also inhibition. |
Active Comparator: Control group AUD
control group: patients with AUD receive standard clinical therapy
|
Behavioral: standard AUD Cognitive Behavioral Therapy (CBT) in Clinical setting.
Patients who voluntarily submit to enter a qualified detoxification treatment program will be examined, either in-patient, out-patient, or in a day-clinic setting at the Department of Addictive Behaviour and Addiction Medicine.
|
Experimental: CB-CRT TUD group
experimental group TUD: patients receive standard smoking cessation therapy and an add-on CB-CRT
|
Behavioral: standard smoking cessation therapy for TUD in group therapy setting. Patients who voluntarily submit to enter a qualified smoking cessation program will be examined in an out-patient setting at the Department of Addictive Behaviour and Addiction Medicine. They receive a six-week standard therapy (one 1,5 hours group therapy per week). Additional, the experimental group receives chess based cognitive remediation treatment (CB-CRT) for 1,5 hours three times a week. The tasks of the treatment were created by our cooperation partner, the psychologist Juan Antonio Montero. He is currently successfully applying this battery as an add-on therapy. The training battery is designed to strengthen cognitive functioning in specific domains such as short-term memory, focal attention, selective attention, pattern recognition, visuospatial abilities, metacognition and also inhibition. |
Active Comparator: Control group TUD
control group: patients with TUD receive standard smoking cessation therapy
|
Behavioral: standard smoking cessation therapy for TUD in group therapy setting. Patients who voluntarily submit to enter a qualified smokind cessation program will be examined in an out-patient setting at the Department of Addictive Behaviour and Addiction Medicine. They receive a six-week standard therapy (one 1,5 hours group therapy per week). Additional, the experimental group receives chess based cognitive remediation treatment (CB-CRT) for 1,5 hours three times a week. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in neural alcohol cue-reactivity
Time Frame: 2 time points: before and after 6 weeks chess-based cognitive training
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fMRI alcohol cue-reactivity task (Vollstädt-Klein et al. 2010)
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2 time points: before and after 6 weeks chess-based cognitive training
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change in neural tobacco cue-reactivity
Time Frame: 2 time points: before and after 6 weeks chess-based cognitive training
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fMRI tobacco cue-reactivity task (Vollstädt-Klein et al. 2011)
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2 time points: before and after 6 weeks chess-based cognitive training
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change in neural correlates of inhibition
Time Frame: 2 time points: before and after 6 weeks chess-based cognitive training
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fMRI stop-signal task (Whelan et al. 2012)
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2 time points: before and after 6 weeks chess-based cognitive training
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substance use (alcohol consumption and tabacco use)
Time Frame: 3 months follow-up after the end of treatment
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self-report
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3 months follow-up after the end of treatment
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change in neural working memory processes
Time Frame: 2 time points: before and after 6 weeks chess-based cognitive training
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fMRI working memory task "N-back" (Charlet et al. 2014)
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2 time points: before and after 6 weeks chess-based cognitive training
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Change in working memory capacity
Time Frame: 2 time points: before and after 6 weeks SCP
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working memory capacity measured by letter-number sequencing task of the [Wechsler Memory Scale (Kent 2013)]; raw values will be transformed to IQ-like scales (mean 100, SD 15); the higher the value, the higher the working memory capacity
|
2 time points: before and after 6 weeks SCP
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Change in impulsivity
Time Frame: 3 time points: before and after 6 weeks SCP plus after 3 months
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impulsivity measured with BIS scale [Barratt impulsiveness scale (Patton et al. 1995)];range 15-60; total score will be used; high values represent high impulsivity
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3 time points: before and after 6 weeks SCP plus after 3 months
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Change in decision-making
Time Frame: 2 time points: before and after 6 weeks SCP
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[Iowa Gambling Task (Bechara et al. 1994)]
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2 time points: before and after 6 weeks SCP
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Change in mental flexibility
Time Frame: 2 time points: before and after 6 weeks SCP
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[Dimensional Change Card Sort (Zelazo et al. 2014)]
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2 time points: before and after 6 weeks SCP
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Change in attentional capacity
Time Frame: 2 time points: before and after 6 weeks SCP
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[d2 Test of Attention (Brickenkamp 2002)].
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2 time points: before and after 6 weeks SCP
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in functional connectivity within the salience network (SN) and executive control network (ECN)
Time Frame: 2 time points: before and after 6 weeks therapy and chess-based cognitive training
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[measured with fMRI]
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2 time points: before and after 6 weeks therapy and chess-based cognitive training
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Collaborators and Investigators
Investigators
- Principal Investigator: Sabine Vollstädt-Klein, Prof. Dr., Central Institute of Mental Health, Mannheim
Publications and helpful links
General Publications
- Blasco-Fontecilla H, Gonzalez-Perez M, Garcia-Lopez R, Poza-Cano B, Perez-Moreno MR, de Leon-Martinez V, Otero-Perez J. Efficacy of chess training for the treatment of ADHD: A prospective, open label study. Rev Psiquiatr Salud Ment. 2016 Jan-Mar;9(1):13-21. doi: 10.1016/j.rpsm.2015.02.003. Epub 2015 Apr 22. English, Spanish.
- Adinoff B. Neurobiologic processes in drug reward and addiction. Harv Rev Psychiatry. 2004 Nov-Dec;12(6):305-20. doi: 10.1080/10673220490910844.
- Fauth-Buhler M, de Rover M, Rubia K, Garavan H, Abbott S, Clark L, Vollstadt-Klein S, Mann K, Schumann G, Robbins TW. Brain networks subserving fixed versus performance-adjusted delay stop trials in a stop signal task. Behav Brain Res. 2012 Nov 1;235(1):89-97. doi: 10.1016/j.bbr.2012.07.023. Epub 2012 Jul 20.
- Amidzic O, Riehle HJ, Fehr T, Wienbruch C, Elbert T. Pattern of focal gamma-bursts in chess players. Nature. 2001 Aug 9;412(6847):603. doi: 10.1038/35088119. No abstract available.
- Atherton M, Zhuang J, Bart WM, Hu X, He S. A functional MRI study of high-level cognition. I. The game of chess. Brain Res Cogn Brain Res. 2003 Mar;16(1):26-31. doi: 10.1016/s0926-6410(02)00207-0.
- Bates ME, Buckman JF, Nguyen TT. A role for cognitive rehabilitation in increasing the effectiveness of treatment for alcohol use disorders. Neuropsychol Rev. 2013 Mar;23(1):27-47. doi: 10.1007/s11065-013-9228-3. Epub 2013 Feb 15.
- Demily C, Cavezian C, Desmurget M, Berquand-Merle M, Chambon V, Franck N. The game of chess enhances cognitive abilities in schizophrenia. Schizophr Res. 2009 Jan;107(1):112-3. doi: 10.1016/j.schres.2008.09.024. Epub 2008 Nov 7. No abstract available.
- Fattahi F, Geshani A, Jafari Z, Jalaie S, Salman Mahini M. Auditory memory function in expert chess players. Med J Islam Repub Iran. 2015 Oct 6;29:275. eCollection 2015.
- Goncalves PD, Ometto M, Bechara A, Malbergier A, Amaral R, Nicastri S, Martins PA, Beraldo L, dos Santos B, Fuentes D, Andrade AG, Busatto GF, Cunha PJ. Motivational interviewing combined with chess accelerates improvement in executive functions in cocaine dependent patients: a one-month prospective study. Drug Alcohol Depend. 2014 Aug 1;141:79-84. doi: 10.1016/j.drugalcdep.2014.05.006. Epub 2014 May 24.
- Onofrj M, Curatola L, Valentini G, Antonelli M, Thomas A, Fulgente T. Non-dominant dorsal-prefrontal activation during chess problem solution evidenced by single photon emission computerized tomography (SPECT). Neurosci Lett. 1995 Oct 6;198(3):169-72. doi: 10.1016/0304-3940(95)11985-6.
- Vollstadt-Klein S, Wichert S, Rabinstein J, Buhler M, Klein O, Ende G, Hermann D, Mann K. Initial, habitual and compulsive alcohol use is characterized by a shift of cue processing from ventral to dorsal striatum. Addiction. 2010 Oct;105(10):1741-9. doi: 10.1111/j.1360-0443.2010.03022.x.
- Lally N, Huys QJM, Eshel N, Faulkner P, Dayan P, Roiser JP. The Neural Basis of Aversive Pavlovian Guidance during Planning. J Neurosci. 2017 Oct 18;37(42):10215-10229. doi: 10.1523/JNEUROSCI.0085-17.2017. Epub 2017 Sep 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chess_SUD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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