NCT04498988

Brief Summary

The aim of this project is to elucidate whether impairments of cognitive control, performance-monitoring, and value-based decision-making and dysfunctional interactions between underlying brain systems are mediating mechanisms and vulnerability factors for daily self-control failures and addictive disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
338

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

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

Study Start

First participant enrolled

December 1, 2014

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

9.3 years

First QC Date

July 27, 2020

Last Update Submit

August 7, 2024

Conditions

Keywords

Cognitive controlDecision-makingImpulsivityRisk-seeking

Outcome Measures

Primary Outcomes (9)

  • Changes in addictive disorder severity

    Changes in number of fulfilled criteria according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)

    At baseline and 1, 2, 3, 4, 5, 6, 7 years after baseline

  • Changes in quantity and frequency of addictive behaviors

    Changes in quantity and frequency of addictive behaviours, which are combined into a quantity-frequency index.

    At baseline and 1, 2, 3, 4, 5, 6, 7 years after baseline

  • Changes in cognitive control abilities

    The Cognitive Control Task Battery of the Collaborative Research Center (CRC) 940 with nine executive function tasks (Stroop, AX continuous performance, color-shape, stop signal, letter memory, number-letter, go-nogo, 2-back, category switch) is used to derive a latent variable representing individual differences in general executive functioning (GEF). For the latent variable modelling error rates and reaction times from the tasks were combined, were appropriate, into inverse efficiency scores (IESs).

    At baseline and 3 and 6 years after baseline

  • Changes in impulsive decision-making

    The Value-Based Decision-Making (VBDM) battery of the Collaborative Research Center (CRC) 940 including four decision-making tasks with a Bayesian adaptive algorithm was used to adaptively assess impulsive decision-making. For the delay and probability discounting tasks, a hyperbolic value function was used describing that the subjective values of delayed (or probabilistic) reward decline hyperbolically according to the discounting rate k. For the mixed gambles task, a simple linear function was used in which loss aversion (λ) is the relative weighting of losses to gains in the participant's. Individuals with higher impulsive decision-making are assumed to display higher k values in the delay discounting task, lower k values in probability discounting tasks, and lower λ values in the mixed gambles task.

    At baseline and 3 and 6 years after baseline

  • Changes in neural correlates of response inhibition

    Blood oxygenation level dependent (BOLD) responses in tasks measuring response inhibition (Go/Nogo, Stroop) using 3 Tesla functional magnetic resonance imaging (fMRI).

    At baseline and 3 and 6 years after baseline

  • Changes in neural correlates of error monitoring

    BOLD responses in a task measuring error monitoring (Stroop) using 3 Tesla fMRI.

    At baseline and 3 and 6 years after baseline

  • Changes in neural correlates of value-based decision-making

    BOLD responses in a task measuring value-based decision-making using 3 Tesla fMRI.

    At baseline and 3 and 6 years after baseline

  • Changes in structural brain characteristics

    Gray matter volume, cortical thickness and white matter properties in theoretically motivated regions of interest (e.g., right inferior frontal gyrus (rIFG), ventromedial prefrontal cortex (vmPFC), anterior cingulate cortex (ACC), anterior insula (aINS)) using 3 Tesla structural MRI.

    At baseline and 3 and 6 years after baseline

  • Changes in real-life self-control

    Everyday self-control was assessed using an Ecological Momentary Assessment (EMA) protocol adapted from Hofmann, Baumeister, Förster, and Vohs (2012). Self-control was defined as enactment of desires in conflict-laden situations.

    At baseline and 3 and 6 years after baseline

Secondary Outcomes (7)

  • Intelligence

    At baseline

  • Personality

    At baseline

  • Positive and negative affect

    At baseline

  • Changes in the action and state orientation

    At baseline and 3 and 6 years after baseline

  • Changes in impulsivity

    At baseline and 3 and 6 years after baseline

  • +2 more secondary outcomes

Study Arms (3)

Substance use disorder (SUD) group

In the substance use disorder (SUD) group, participants had a diagnosis of alcohol and/or tobacco use disorder according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) but no lifetime non-substance-related addictive disorder (ND).

Other: Observational study without interventions

Non-substance-related addictive disorder (ND) group

In the non-substance-related addictive disorder (ND) group, participants were included who fulfilled two or more criteria for a DSM-5 gambling disorder or for an addictive behavior related to Internet use (not for gambling, gaming, or shopping), gaming, or shopping assessed with adapted criteria from DSM-5 substance use disorder (SUD). Participants in the ND group had no lifetime SUD.

Other: Observational study without interventions

Control group

The control participants had no current or lifetime substance use disorder (SUD) or non-substance-related addictive disorder (ND).

Other: Observational study without interventions

Interventions

Control groupNon-substance-related addictive disorder (ND) groupSubstance use disorder (SUD) group

Eligibility Criteria

Age19 Years - 27 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The age range was 19 to 27 years at baseline. As expected for our sampling procedure, the addictive disorder severity was mainly mild (baseline 62%) and moderate (baseline 28%).

You may qualify if:

  • age 19-27
  • fulfill the criteria for one of three groups (SUD, ND, controls)
  • written informed consent

You may not qualify if:

  • no written informed consent or limited ability to understand the questionnaires and tasks
  • disorders that might influence cognition or motor performance (e.g. craniocerebral injury)
  • magnetic resonance contraindications
  • current treatment for mental disorders
  • current use of psychotropic medication or substances
  • lifetime psychotic symptoms, bipolar disorder, or other SUD or ND not under study
  • major depression, somatoform, anxiety, obsessive compulsive, or eating disorders within the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technische Universität Dresden, Faculty of Psychology

Dresden, 01062, Germany

Location

Related Publications (13)

  • Kraplin A. Conceptualizing behavioural addiction in children and adolescents. Addiction. 2017 Oct;112(10):1721-1723. doi: 10.1111/add.13846. Epub 2017 May 15. No abstract available.

    PMID: 28508582BACKGROUND
  • Kronke KM, Wolff M, Benz A, Goschke T. Successful smoking cessation is associated with prefrontal cortical function during a Stroop task: A preliminary study. Psychiatry Res. 2015 Oct 30;234(1):52-6. doi: 10.1016/j.pscychresns.2015.08.005. Epub 2015 Aug 20.

    PMID: 26321462BACKGROUND
  • Wolff M, Kronke KM, Goschke T. Trait self-control is predicted by how reward associations modulate Stroop interference. Psychol Res. 2016 Nov;80(6):944-951. doi: 10.1007/s00426-015-0707-4. Epub 2015 Sep 24.

    PMID: 26403462BACKGROUND
  • Kraplin A, Hofler M, Pooseh S, Wolff M, Kronke KM, Goschke T, Buhringer G, Smolka MN. Impulsive decision-making predicts the course of substance-related and addictive disorders. Psychopharmacology (Berl). 2020 Sep;237(9):2709-2724. doi: 10.1007/s00213-020-05567-z. Epub 2020 Jun 5.

  • Kronke KM, Wolff M, Mohr H, Kraplin A, Smolka MN, Buhringer G, Goschke T. Predicting Real-Life Self-Control From Brain Activity Encoding the Value of Anticipated Future Outcomes. Psychol Sci. 2020 Mar;31(3):268-279. doi: 10.1177/0956797619896357. Epub 2020 Feb 5.

  • Wolff M, Kronke KM, Venz J, Kraplin A, Buhringer G, Smolka MN, Goschke T. Action versus state orientation moderates the impact of executive functioning on real-life self-control. J Exp Psychol Gen. 2016 Dec;145(12):1635-1653. doi: 10.1037/xge0000229. Epub 2016 Oct 13.

  • Kronke KM, Wolff M, Mohr H, Kraplin A, Smolka MN, Buhringer G, Goschke T. Monitor yourself! Deficient error-related brain activity predicts real-life self-control failures. Cogn Affect Behav Neurosci. 2018 Aug;18(4):622-637. doi: 10.3758/s13415-018-0593-5.

  • Kronke KM, Wolff M, Shi Y, Kraplin A, Smolka MN, Buhringer G, Goschke T. Functional connectivity in a triple-network saliency model is associated with real-life self-control. Neuropsychologia. 2020 Dec;149:107667. doi: 10.1016/j.neuropsychologia.2020.107667. Epub 2020 Oct 31.

  • Wolff M, Enge S, Kraplin A, Kronke KM, Buhringer G, Smolka MN, Goschke T. Chronic stress, executive functioning, and real-life self-control: An experience sampling study. J Pers. 2021 May;89(3):402-421. doi: 10.1111/jopy.12587. Epub 2020 Sep 3.

  • Kronke KM, Mohr H, Wolff M, Kraplin A, Smolka MN, Buhringer G, Ruge H, Goschke T. Real-Life Self-Control is Predicted by Parietal Activity During Preference Decision Making: A Brain Decoding Analysis. Cogn Affect Behav Neurosci. 2021 Oct;21(5):936-947. doi: 10.3758/s13415-021-00913-w. Epub 2021 Jun 1.

  • Kraplin A, Joshanloo M, Wolff M, Kronke KM, Goschke T, Buhringer G, Smolka MN. The relationship between executive functioning and addictive behavior: new insights from a longitudinal community study. Psychopharmacology (Berl). 2022 Nov;239(11):3507-3524. doi: 10.1007/s00213-022-06224-3. Epub 2022 Oct 3.

  • Kraplin A, Kupka KF, Fröhner JH, Krönke K-M, Wolff M, Smolka MN, Bühringer G, Goschke T. Personality Traits Predict Non-Substance Related and Substance Related Addictive Behaviours. SUCHT. 2022; 68(5), 263-277. doi:10.1024/0939-5911/a000780

    RESULT
  • Kraplin A, Joshanloo M, Wolff M, Frohner JH, Baeuchl C, Kronke KM, Buhringer G, Smolka MN, Goschke T. No evidence for a reciprocal relationship between daily self-control failures and addictive behavior in a longitudinal study. Front Psychol. 2024 May 1;15:1382483. doi: 10.3389/fpsyg.2024.1382483. eCollection 2024.

MeSH Terms

Conditions

Behavior, AddictiveAlcoholismTobacco Use DisorderSelf-ControlImpulsive Behavior

Interventions

ObservationMethods

Condition Hierarchy (Ancestors)

Compulsive BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersSocial Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Thomas Goschke, Prof. Dr.

    Technische Universität Dresden

    PRINCIPAL INVESTIGATOR
  • Michael N. Smolka, Prof. Dr.

    Technische Universität Dresden

    PRINCIPAL INVESTIGATOR
  • Gerhard Bühringer, Prof. Dr.

    Technische Universität Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2020

First Posted

August 5, 2020

Study Start

December 1, 2014

Primary Completion

March 31, 2024

Study Completion

June 30, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

Data and analytic codes within publications will be shared via the Open Science Framework (OSF). Final archiving of the participant data will be conducted with the Open Access Repository and Archive at the Technische Universität Dresden (OpARA).

Shared Documents
ANALYTIC CODE
Time Frame
Data and analytic codes within publications will be shared from the time of publications. Final archived data will be shared after the study is completed in 2024.
Access Criteria
Open Access
More information

Available IPD Datasets

Official study group website Access
English description of the Collaborative Research Centre Access

Locations