Volitional Dysfunction in Self-control Failures and Addictive Behaviors

August 7, 2024 updated by: Technische Universität Dresden
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
338

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01062
        • Technische Universität Dresden, Faculty of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 27 years (Adult)

Accepts Healthy Volunteers

Yes

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%).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
At baseline and 1, 2, 3, 4, 5, 6, 7 years after baseline
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.
At baseline and 1, 2, 3, 4, 5, 6, 7 years after baseline
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).
At baseline and 3 and 6 years after baseline
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.
At baseline and 3 and 6 years after baseline
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).
At baseline and 3 and 6 years after baseline
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.
At baseline and 3 and 6 years after baseline
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.
At baseline and 3 and 6 years after baseline
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.
At baseline and 3 and 6 years after baseline
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.
At baseline and 3 and 6 years after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intelligence
Time Frame: At baseline
As control variable we assessed the intelligence quotient (IQ) using the Wechsler Intelligence Test for Adults (WIE).
At baseline
Personality
Time Frame: At baseline
As moderator variable we assessed the NEO Five Factor Inventory (NEO-FFI; outcomes are the sum scores).
At baseline
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).
At baseline
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).
At baseline and 3 and 6 years after baseline
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).
At baseline and 3 and 6 years after baseline
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).
At baseline and 3 and 6 years after baseline
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).
At baseline and 3 and 6 years after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Technische Universität Dresden

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
German Research Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SFB940 C01
  • Project number 178833530 (Other Grant/Funding Number: Deutsche Forschungsgemeinschaft (DFG))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

IPD Sharing 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.

IPD Sharing Access Criteria

Open Access

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Study Data/Documents

  1. Official study group website
  2. English description of the Collaborative Research Centre
    Information comments: The study is conducted within the Collaborative Research Centre 940 funded by the Deutsche Forschungsgemeinschaft (DFG).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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