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

Sponsor
Central Institute of Mental Health, Mannheim (Other)
Overall Status
Recruiting
CT.gov ID
NCT04057534
Collaborator
(none)
96
1
4
29
3.3

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Standard therapy for AUD plus Chess-based cognitive treatment
  • Behavioral: Standard therapy for AUD
  • Behavioral: Standard smoking cessation therapy for TUD plus Chess-based cognitive treatment
  • Behavioral: Standard therapy for TUD
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigating Neurobiological Mechanisms of Chess as an Add-On Treatment Against Substance Use Disorder
Actual Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

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 therapy for AUD plus Chess-based cognitive treatment
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 therapy for AUD
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 plus Chess-based cognitive treatment
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 therapy for TUD
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.

Outcome Measures

Primary Outcome Measures

  1. change in neural alcohol cue-reactivity [2 time points: before and after 6 weeks chess-based cognitive training]

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

  2. change in neural tobacco cue-reactivity [2 time points: before and after 6 weeks chess-based cognitive training]

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

  3. change in neural correlates of inhibition [2 time points: before and after 6 weeks chess-based cognitive training]

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

  4. substance use (alcohol consumption and tabacco use) [3 months follow-up after the end of treatment]

    self-report

  5. change in neural working memory processes [2 time points: before and after 6 weeks chess-based cognitive training]

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

  6. Change in working memory capacity [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

  7. Change in impulsivity [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

  8. Change in decision-making [2 time points: before and after 6 weeks SCP]

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

  9. Change in mental flexibility [2 time points: before and after 6 weeks SCP]

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

  10. Change in attentional capacity [2 time points: before and after 6 weeks SCP]

    [d2 Test of Attention (Brickenkamp 2002)].

Secondary Outcome Measures

  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]

    [measured with fMRI]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit Mannheim Germany

Sponsors and Collaborators

  • Central Institute of Mental Health, Mannheim

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier:
NCT04057534
Other Study ID Numbers:
  • Chess_SUD
First Posted:
Aug 15, 2019
Last Update Posted:
Sep 8, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Central Institute of Mental Health, Mannheim
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2021