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Completed

NCT Number: NCT04498988

Volitional Dysfunction in Self-control Failures and Addictive Behaviors

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.

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Key information

Age range

19 year–27 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Technische Universität Dresden, Faculty of Psychology

Dresden, 01062, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(at baseline):

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

Exclusion criteria

(at baseline):

  • 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

Treatment and study plan

Observational study without interventions

Other

Primary outcomes

  1. Changes in addictive disorder severity

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

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

  2. Changes in quantity and frequency of addictive behaviors

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

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

  3. Changes in cognitive control abilities

    Time frame: At baseline and 3 and 6 years after baseline

    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).

  4. Changes in impulsive decision-making

    Time frame: At baseline and 3 and 6 years after baseline

    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.

  5. Changes in neural correlates of response inhibition

    Time frame: At baseline and 3 and 6 years after baseline

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

  6. Changes in neural correlates of error monitoring

    Time frame: At baseline and 3 and 6 years after baseline

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

  7. Changes in neural correlates of value-based decision-making

    Time frame: At baseline and 3 and 6 years after baseline

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

  8. Changes in structural brain characteristics

    Time frame: At baseline and 3 and 6 years after baseline

    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.

  9. Changes in real-life self-control

    Time frame: At baseline and 3 and 6 years after baseline

    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.

Secondary outcomes

  1. Intelligence

    Time frame: At baseline

    As control variable we assessed the intelligence quotient (IQ) using the Wechsler Intelligence Test for Adults (WIE).

  2. Personality

    Time frame: At baseline

    As moderator variable we assessed the NEO Five Factor Inventory (NEO-FFI; outcomes are the sum scores).

  3. Positive and negative affect

    Time frame: At baseline

    As moderator variable we assessed the Positive and Negative Affect Schedule (PANAS; outcomes are the sum scores).

  4. Changes in the action and state orientation

    Time frame: At baseline and 3 and 6 years after baseline

    As moderator variable we assessed the Action-State Orientation Scale (ACS-90; outcomes are the sum scores).

  5. Changes in impulsivity

    Time frame: At baseline and 3 and 6 years after baseline

    As moderator variable we assessed the Barratt Impulsiveness Scale (BIS-11; outcome is the sum score).

  6. Changes in self control

    Time frame: At baseline and 3 and 6 years after baseline

    As moderator variable we assessed the Brief Self-Control Scale (BSCS; outcome is the sum score).

  7. Changes in chronic stress

    Time frame: At baseline and 3 and 6 years after baseline

    As moderator variable we assessed the Trier Inventory for Chronic Stress (TICS; outcome is the sum score).

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • German Research Foundation

Registry information

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Aug 5, 2020
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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