Clinical trial NCT04498988: Volitional Dysfunction in Self-control Failures and Addictive Behaviors
Official title: Volitional Dysfunction in Self-control Failures and Addictive Behaviors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Addictive Behavior
Alcohol Use Disorder (AUD)
Tobacco Use Disorder
Self-Control
Executive Dysfunction
Keywords: Cognitive control
Decision-making
Impulsivity
Risk-seeking
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2020-08-05
Enrollment: 338
Sex: ALL
Minimum age (years): 19
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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%).

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.

Detailed description: Failures of self-control during conflicts between long-term goals and immediate desires are a key characteristic of many harmful behaviors, including unhealthy eating habits, lack of exercise and problematic substance use, which often have adverse personal consequences and incur great societal costs. The project aims to elucidate neurocognitive mechanisms mediating deficient self-control, both in daily self-control failures and in substance use disorders and behavioral addictions, which are characterized by a loss of control despite awareness of adverse consequences. A prospective cohort study was launched using a multi-level approach that combines (i) a comprehensive clinical assessment, (ii) behavioral task batteries assessing cognitive control and decision-making functions, (iii) task-related and resting state fMRI, and (iv) Smartphone-based ecological momentary assessment of daily self-control failures. From a representative community sample, three groups of participants were recruited (each n = 100; age 20 - 26) with (a) symptoms of non-substance related and (b) substance-related addictive disorders and (c) syndrome-free controls. Participants are invited to yearly clinical follow-up assessments and further multi-level assessments 3 and 6 years after initial recruitment. Results obtained so far (until 06/2020) provide converging evidence that task performance as well as brain activity in monitoring, control, and valuation networks is reliably associated with the propensity to commit real-life self-control failures. Results support a process model, according to which deficient performance-monitoring leads to an insufficient recruitment of control networks, which attenuates the impact of long-term goals on neural value signals and increases the likelihood of self-control failures. In the final funding period (until 06/2024), the clinical follow-up period will be extended to 7 years. In addition, stress markers will be assessed as possible moderators of self-control. With the cross-lagged panel design it is expected to make a substantial contribution to the central unresolved question whether dysfunctions of cognitive control are causally involved in the development and trajectories of self-control failures and addictive behaviors, as well as to the disputed question of communalities and differences between different addictive disorders. Thereby, the project will to contribute to mechanism-based models of self-control impairments as a foundation for improved prevention and therapy.

Eligibility criteria: Inclusion Criteria (at baseline):

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

Exclusion Criteria (at baseline):

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

Primary outcomes:
measure: Changes in addictive disorder severity
timeFrame: At baseline and 1, 2, 3, 4, 5, 6, 7 years after baseline
measure: Changes in quantity and frequency of addictive behaviors
timeFrame: At baseline and 1, 2, 3, 4, 5, 6, 7 years after baseline
measure: Changes in cognitive control abilities
timeFrame: At baseline and 3 and 6 years after baseline
measure: Changes in impulsive decision-making
timeFrame: At baseline and 3 and 6 years after baseline
measure: Changes in neural correlates of response inhibition
timeFrame: At baseline and 3 and 6 years after baseline
measure: Changes in neural correlates of error monitoring
timeFrame: At baseline and 3 and 6 years after baseline
measure: Changes in neural correlates of value-based decision-making
timeFrame: At baseline and 3 and 6 years after baseline
measure: Changes in structural brain characteristics
timeFrame: At baseline and 3 and 6 years after baseline
measure: Changes in real-life self-control
timeFrame: At baseline and 3 and 6 years after baseline
Secondary outcomes:
measure: Intelligence
timeFrame: At baseline
measure: Personality
timeFrame: At baseline
measure: Positive and negative affect
timeFrame: At baseline
measure: Changes in the action and state orientation
timeFrame: At baseline and 3 and 6 years after baseline
measure: Changes in impulsivity
timeFrame: At baseline and 3 and 6 years after baseline
measure: Changes in self control
timeFrame: At baseline and 3 and 6 years after baseline
measure: Changes in chronic stress
timeFrame: At baseline and 3 and 6 years after baseline
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Technische Universität Dresden, Faculty of Psychology
Study officials:
affiliation: Technische Universität Dresden
name: Thomas Goschke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Technische Universität Dresden
name: Michael N. Smolka, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Technische Universität Dresden
name: Gerhard Bühringer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.