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

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).

Study Overview

Detailed Description

The study aims to investigate the potential mechanism of action of chess as a "chess based - cognitive remediation treatment, CB-CRT" to reduce cognitive deficits in individuals with substance use disorder (SUD) seeking treatment using neurobiological and neuropsychological approaches. Furthermore, it will be assessed whether this chess intervention has a generalized positive effect on short-term abstinence. Interestingly, the functional domains and associated underlying neuronal networks observed to be affected in individuals with SUD overlap significantly with those that could be strengthened by chess-based cognitive training or formal chess. Specifically, strengthening of cortical control regions (dorsolateral prefrontal cortex, DLPFC) and brain areas relevant for decision-making (orbitofrontal cortex, OFC) could prevent future relapse. Therefore, chess as an add-on therapy to complement other standard treatments of SUD could lead to improved therapeutic outcomes.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)

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
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
Time Frame: 2 time points: before and after 6 weeks chess-based cognitive training
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
Time Frame: 2 time points: before and after 6 weeks chess-based cognitive training
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)
Time Frame: 3 months follow-up after the end of treatment
self-report
3 months follow-up after the end of treatment
change in neural working memory processes
Time Frame: 2 time points: before and after 6 weeks chess-based cognitive training
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
Time Frame: 2 time points: before and after 6 weeks SCP
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
Time Frame: 3 time points: before and after 6 weeks SCP plus after 3 months
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
Time Frame: 2 time points: before and after 6 weeks SCP
[Iowa Gambling Task (Bechara et al. 1994)]
2 time points: before and after 6 weeks SCP
Change in mental flexibility
Time Frame: 2 time points: before and after 6 weeks SCP
[Dimensional Change Card Sort (Zelazo et al. 2014)]
2 time points: before and after 6 weeks SCP
Change in attentional capacity
Time Frame: 2 time points: before and after 6 weeks SCP
[d2 Test of Attention (Brickenkamp 2002)].
2 time points: before and after 6 weeks SCP

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
[measured with fMRI]
2 time points: before and after 6 weeks therapy and chess-based cognitive training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sabine Vollstädt-Klein, Prof. Dr., Central Institute of Mental Health, Mannheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

November 17, 2023

Study Completion (Actual)

November 17, 2023

Study Registration Dates

First Submitted

August 12, 2019

First Submitted That Met QC Criteria

August 13, 2019

First Posted (Actual)

August 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After publication

IPD Sharing Access Criteria

Upon request by researchers or institution following the current data protection laws.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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