NCT04057534

Brief Summary

Neurobiological and neuropsychological approaches to investigate the potential mechanism of action of chess as an add-on therapy (chess based - cognitive remediation treatment, CB-CRT) to reduce cognitive deficits in individuals with alcohol use disorder (AUD) or tobacco use disorder (TUD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2023

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

3.6 years

First QC Date

August 12, 2019

Last Update Submit

March 28, 2024

Conditions

Keywords

Alcohol DependenceAlcoholismCravingCognitive Changecognitive remediationChess based cognitive trainingWorking MemoryDecision MakingExecutive ControlChessfMRINicotine use disorderTobacco use disorder

Outcome Measures

Primary Outcomes (10)

  • change in neural alcohol cue-reactivity

    fMRI alcohol cue-reactivity task (Vollstädt-Klein et al. 2010)

    2 time points: before and after 6 weeks chess-based cognitive training

  • change in neural tobacco cue-reactivity

    fMRI tobacco cue-reactivity task (Vollstädt-Klein et al. 2011)

    2 time points: before and after 6 weeks chess-based cognitive training

  • change in neural correlates of inhibition

    fMRI stop-signal task (Whelan et al. 2012)

    2 time points: before and after 6 weeks chess-based cognitive training

  • substance use (alcohol consumption and tabacco use)

    self-report

    3 months follow-up after the end of treatment

  • change in neural working memory processes

    fMRI working memory task "N-back" (Charlet et al. 2014)

    2 time points: before and after 6 weeks chess-based cognitive training

  • Change in working memory capacity

    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

  • Change in impulsivity

    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

    3 time points: before and after 6 weeks SCP plus after 3 months

  • Change in decision-making

    \[Iowa Gambling Task (Bechara et al. 1994)\]

    2 time points: before and after 6 weeks SCP

  • Change in mental flexibility

    \[Dimensional Change Card Sort (Zelazo et al. 2014)\]

    2 time points: before and after 6 weeks SCP

  • Change in attentional capacity

    \[d2 Test of Attention (Brickenkamp 2002)\].

    2 time points: before and after 6 weeks SCP

Secondary Outcomes (1)

  • change in functional connectivity within the salience network (SN) and executive control network (ECN)

    2 time points: before and after 6 weeks therapy and chess-based cognitive training

Study Arms (4)

CB-CRT AUD group

EXPERIMENTAL

experimental group AUD: patients receive standard clinical therapy and an add-on chess based - cognitive remediation treatment (CB-CRT)

Behavioral: Standard therapy for AUD plus Chess-based cognitive treatment

Control group AUD

ACTIVE COMPARATOR

control group: patients with AUD receive standard clinical therapy

Behavioral: Standard therapy for AUD

CB-CRT TUD group

EXPERIMENTAL

experimental group TUD: patients receive standard smoking cessation therapy and an add-on CB-CRT

Behavioral: Standard smoking cessation therapy for TUD plus Chess-based cognitive treatment

Control group TUD

ACTIVE COMPARATOR

control group: patients with TUD receive standard smoking cessation therapy

Behavioral: Standard therapy for TUD

Interventions

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.

CB-CRT AUD group

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.

Control group AUD

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.

CB-CRT TUD group

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.

Control group TUD

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • suicidality or endangerment of others
  • positive Covid-19 screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Germany

Location

Related Publications (13)

  • Adinoff B. Neurobiologic processes in drug reward and addiction. Harv Rev Psychiatry. 2004 Nov-Dec;12(6):305-20. doi: 10.1080/10673220490910844.

    PMID: 15764467BACKGROUND
  • 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.

    PMID: 22820235BACKGROUND
  • 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.

  • 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.

  • 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.

  • Gerhardt S, Lex G, Holzammer J, Karl D, Wieland A, Schmitt R, Recuero AJ, Montero JA, Weber T, Vollstadt-Klein S. Effects of chess-based cognitive remediation training as therapy add-on in alcohol and tobacco use disorders: protocol of a randomised, controlled clinical fMRI trial. BMJ Open. 2022 Sep 6;12(9):e057707. doi: 10.1136/bmjopen-2021-057707.

MeSH Terms

Conditions

Substance-Related DisordersAlcoholismTobacco Use Disorder

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Sabine Vollstädt-Klein, Prof. Dr.

    Central Institute of Mental Health, Mannheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 15, 2019

Study Start

April 1, 2020

Primary Completion

November 17, 2023

Study Completion

November 17, 2023

Last Updated

March 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

For protection of personal rights, and due to the sensitivity of the clinical and neuroimaging data, data will not be made publicly available. Upon direct request by other researchers and in mutual agreements (e.g., regarding data protection), anonymized data can be made available. Upon request, analysis procedures and codes will be shared with other researchers.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
After publication
Access Criteria
Upon request by researchers or institution following the current data protection laws.

Locations