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Neurobiological Mechanisms of Chess as an Add-On Treatment Against SUD (Chess_SUD)

Primary Purpose

Substance Use Disorders

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Standard therapy for AUD plus Chess-based cognitive treatment

Standard therapy for AUD

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

Standard therapy for TUD

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Alcohol Dependence, Alcoholism, Craving, Cognitive Change, cognitive remediation, Chess based cognitive training, Working Memory, Decision Making, Executive Control, Chess, fMRI, Nicotine use disorder, Tobacco use disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische GesundheitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

CB-CRT AUD group

Control group AUD

CB-CRT TUD group

Control group TUD

Arm Description

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

control group: patients with AUD receive standard clinical therapy

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

control group: patients with TUD receive standard smoking cessation therapy

Outcomes

Primary Outcome Measures

change in neural alcohol cue-reactivity

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

change in neural tobacco cue-reactivity

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

change in neural correlates of inhibition

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

substance use (alcohol consumption and tabacco use)

self-report

change in neural working memory processes

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

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

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

Change in decision-making

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

Change in mental flexibility

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

Change in attentional capacity

[d2 Test of Attention (Brickenkamp 2002)].

Secondary Outcome Measures

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

[measured with fMRI]

Full Information

NCT ID

NCT04057534

First Posted

August 12, 2019

Last Updated

January 24, 2023

Sponsor

Central Institute of Mental Health, Mannheim

1. Study Identification

Unique Protocol Identification Number

NCT04057534

Brief Title

Neurobiological Mechanisms of Chess as an Add-On Treatment Against SUD

Acronym

Chess_SUD

Official Title

Investigating Neurobiological Mechanisms of Chess as an Add-On Treatment Against Substance Use Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2020 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central Institute of Mental Health, Mannheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Use Disorders

Keywords

Alcohol Dependence, Alcoholism, Craving, Cognitive Change, cognitive remediation, Chess based cognitive training, Working Memory, Decision Making, Executive Control, Chess, fMRI, Nicotine use disorder, Tobacco use disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CB-CRT AUD group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group AUD

Arm Type

Active Comparator

Arm Description

control group: patients with AUD receive standard clinical therapy

Arm Title

CB-CRT TUD group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group TUD

Arm Type

Active Comparator

Arm Description

control group: patients with TUD receive standard smoking cessation therapy

Intervention Type

Behavioral

Intervention Name(s)

Standard therapy for AUD plus Chess-based cognitive treatment

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Standard therapy for AUD

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Standard therapy for TUD

Intervention Description

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.

Primary Outcome Measure Information:

Title

change in neural alcohol cue-reactivity

Description

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

Time Frame

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

Title

change in neural tobacco cue-reactivity

Description

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

Time Frame

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

Title

change in neural correlates of inhibition

Description

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

Time Frame

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

Title

substance use (alcohol consumption and tabacco use)

Description

self-report

Time Frame

3 months follow-up after the end of treatment

Title

change in neural working memory processes

Description

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

Time Frame

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

Title

Change in working memory capacity

Description

Time Frame

2 time points: before and after 6 weeks SCP

Title

Change in impulsivity

Description

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

Time Frame

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

Title

Change in decision-making

Description

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

Time Frame

2 time points: before and after 6 weeks SCP

Title

Change in mental flexibility

Description

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

Time Frame

2 time points: before and after 6 weeks SCP

Title

Change in attentional capacity

Description

[d2 Test of Attention (Brickenkamp 2002)].

Time Frame

2 time points: before and after 6 weeks SCP

Secondary Outcome Measure Information:

Title

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

Description

[measured with fMRI]

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sabine Vollstädt-Klein, Prof. Dr.

Phone

+49-621/1703

Ext

3912

s.vollstaedt-klein@zi-mannheim.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sabine Vollstädt-Klein, Prof. Dr.

Organizational Affiliation

Central Institute of Mental Health, Mannheim

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

City

Mannheim

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sabine Vollstädt-Klein

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

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15764467

Citation

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Results Reference

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PubMed Identifier

22820235

Citation

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.

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Neurobiological Mechanisms of Chess as an Add-On Treatment Against SUD

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