Effect of Social Isolation on the Role of Pavlovian Mechanisms for Control Over Alcohol Use
NCT ID: NCT06256952
Last Updated: 2024-08-28
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2024-10-01
2027-06-30
Brief Summary
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Investigate the effect of experimentally induced social exclusion on alcohol-specific and general PIT effects in AUD and control participants.
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Detailed Description
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The investigators will examine how an experimentally induced social exclusion by the Cyberball task is associated with alcohol specific and general PIT effects by using the newly developed full transfer task from 1st funding period in AUD vs. HCs.
The investigators will use the newly developed full PIT paradigm to examine the modifying effect of experimentally induced social exclusion stress on alcohol-specific and general PIT effects. While using the Trier Social Stress Test in the 1st FP, the investigators now want to go one step further by including social exclusion/ostracism to the stress component, which has not been studied in association with PIT effects yet. The investigators here want to shed light on possible underlying mechanisms which can lead to a promotion of alcohol-seeking by alcohol-stimuli in situations of social exclusion.
Participants (50 AUD and 50 HC) will be assessed at two time points, once after experimentally induced social exclusion and once after social inclusion in a fully balanced, cross-over within-subject design. Subjects will play an online game tossing a ball to each other with two more virtual co-players (Cyberball). Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player (partial exclusion), and during social inclusion, ball tosses will be balanced between all three players. Cyberball usually induces feelings of social isolation and altered behavioral reactions in the subject, which the investigators want to assess by analyzing ball tossing behavior over time, as well as physiological and subjective measures (concentration of cortisol in saliva, heart rate variability and emotions questionnaires, such as the Need to Belong Scale, Rejection Sensitivity Questionnaire, Need threat scale and Positive and Negative Affect Schedule pre and post Cyberball game and after PIT). After the Cyberball experiment, subjects will undergo the transfer part of the full PIT task (using a parallel version at one of the two days in a randomized order).
Hypothesis 1a:
Social exclusion will lead to a stronger stress hormone response (concentration of cortisol in saliva), lower heart rate variability and a stronger general PIT effect compared to social inclusion (main effect social exclusion intervention on PIT).
Hypothesis 1b:
Stronger social exclusion effects in AUD subjects compared to controls will lead to stronger PIT effects compared to social inclusion (interaction effect between group and stress intervention on PIT), especially for alcohol-specific PIT.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Control (HC) - exclusion first
Healthy participants without SUD Cyberball: Exclusion Day 1; Cyberball: Inclusion Day 2
PIT paradigm
The paradigm consists of four parts:
In the first part, an instrumental learning task is completed in which subjects must learn which stimuli require a response and which do not. In the second part, a classical (Pavlovian) conditioning task is then completed in which subjects learn by passive viewing which stimuli are associated with certain amounts of money. The third part measures to which instrumental responses (learned in Part 1) are modulated by the presentation of the classically conditioned stimuli (learned in Part 2). At the same time drug-associated stimuli are presented in the background measuring to which extent they conflict with the learned instrumental behavior. In the last part, query trials are implemented in which the participants have to choose between two pictures to assess the relative cue value.
social exclusion (Cyberball task)
Social exclusion will be assessed using the cyberball paradigm: subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player, and during social inclusion, ball tosses will be balanced between all three players.
Saliva samples
Assessing acute stress effects in AUD and HC subjects
basic psychological assessment
* Sociodemographics
* ASSIST
* Quantity Frequency: Alcohol, tobacco/e-cigarette, Cannabis \& other illegal drugs
* SCID: AUD criteria and tabak use disorder life time and last year \& acute depressive symptoms \& symptoms for Mania and psychotic disorder
* Edinburgh Handedness Inventory (EHI)
* Fagerström Test for Nicotine depend (FTND)
* Barratt Impulsiveness Scale - Kurzversion (BIS-15)
* Allgemeine Depressionsskala (ADS)
* State-Trait-Anxiety Inventory (STAI-T)
* Alcohol Use Disorders Identification Test (AUDIT)
* Cannabis Use Disorder Identification Test (CUDIT)
* CAS -A (Alkohol)
* Fragebogen zur Sozialen Unterstützung (F-SozU K-14)
* Oslo-3-Items-Social-Support Scale
* Social Skills Rating System (SSRS)
* Trier Inventory for chronic stress (TICS)
* Rejection Sensitivity Questionnaires (RSQ-9)
* Need to belong scale (NTBS)
* Fragebogen zu Gedanken und Gefühlen (FGG-14)
* Internationale Trauma Questionnaire (ITQ)
* Zahlen-Symbol-Test (DST)
* Wortschatztest (verbal intelligence)
pre and post cyberball task
Positive and Negative Affect Schedule(PANAS)
VAS
subjective arousal, subjective stress, valence, perceived ostracisms/loneliness
after cyberball task
* Need Threat Scale
* Manipulation check (VAS scale)
social inclusion (Cyberball task)
Social inclusion will be assessed using the cyberball paradigm: subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social inclusion, ball tosses will be balanced between all three players.
Control (HC) - inclusion first
Healthy participants without SUD Cyberball: Inclusion Day 1; Cyberball: Exclusion Day 2
PIT paradigm
The paradigm consists of four parts:
In the first part, an instrumental learning task is completed in which subjects must learn which stimuli require a response and which do not. In the second part, a classical (Pavlovian) conditioning task is then completed in which subjects learn by passive viewing which stimuli are associated with certain amounts of money. The third part measures to which instrumental responses (learned in Part 1) are modulated by the presentation of the classically conditioned stimuli (learned in Part 2). At the same time drug-associated stimuli are presented in the background measuring to which extent they conflict with the learned instrumental behavior. In the last part, query trials are implemented in which the participants have to choose between two pictures to assess the relative cue value.
social exclusion (Cyberball task)
Social exclusion will be assessed using the cyberball paradigm: subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player, and during social inclusion, ball tosses will be balanced between all three players.
Saliva samples
Assessing acute stress effects in AUD and HC subjects
basic psychological assessment
* Sociodemographics
* ASSIST
* Quantity Frequency: Alcohol, tobacco/e-cigarette, Cannabis \& other illegal drugs
* SCID: AUD criteria and tabak use disorder life time and last year \& acute depressive symptoms \& symptoms for Mania and psychotic disorder
* Edinburgh Handedness Inventory (EHI)
* Fagerström Test for Nicotine depend (FTND)
* Barratt Impulsiveness Scale - Kurzversion (BIS-15)
* Allgemeine Depressionsskala (ADS)
* State-Trait-Anxiety Inventory (STAI-T)
* Alcohol Use Disorders Identification Test (AUDIT)
* Cannabis Use Disorder Identification Test (CUDIT)
* CAS -A (Alkohol)
* Fragebogen zur Sozialen Unterstützung (F-SozU K-14)
* Oslo-3-Items-Social-Support Scale
* Social Skills Rating System (SSRS)
* Trier Inventory for chronic stress (TICS)
* Rejection Sensitivity Questionnaires (RSQ-9)
* Need to belong scale (NTBS)
* Fragebogen zu Gedanken und Gefühlen (FGG-14)
* Internationale Trauma Questionnaire (ITQ)
* Zahlen-Symbol-Test (DST)
* Wortschatztest (verbal intelligence)
pre and post cyberball task
Positive and Negative Affect Schedule(PANAS)
VAS
subjective arousal, subjective stress, valence, perceived ostracisms/loneliness
after cyberball task
* Need Threat Scale
* Manipulation check (VAS scale)
social inclusion (Cyberball task)
Social inclusion will be assessed using the cyberball paradigm: subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social inclusion, ball tosses will be balanced between all three players.
Moderate to sever alcohol users (AUD) - exclusion first
Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD) Cyberball: Exclusion Day 1; Cyberball: Inclusion Day 2
PIT paradigm
The paradigm consists of four parts:
In the first part, an instrumental learning task is completed in which subjects must learn which stimuli require a response and which do not. In the second part, a classical (Pavlovian) conditioning task is then completed in which subjects learn by passive viewing which stimuli are associated with certain amounts of money. The third part measures to which instrumental responses (learned in Part 1) are modulated by the presentation of the classically conditioned stimuli (learned in Part 2). At the same time drug-associated stimuli are presented in the background measuring to which extent they conflict with the learned instrumental behavior. In the last part, query trials are implemented in which the participants have to choose between two pictures to assess the relative cue value.
social exclusion (Cyberball task)
Social exclusion will be assessed using the cyberball paradigm: subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player, and during social inclusion, ball tosses will be balanced between all three players.
Saliva samples
Assessing acute stress effects in AUD and HC subjects
basic psychological assessment
* Sociodemographics
* ASSIST
* Quantity Frequency: Alcohol, tobacco/e-cigarette, Cannabis \& other illegal drugs
* SCID: AUD criteria and tabak use disorder life time and last year \& acute depressive symptoms \& symptoms for Mania and psychotic disorder
* Edinburgh Handedness Inventory (EHI)
* Fagerström Test for Nicotine depend (FTND)
* Barratt Impulsiveness Scale - Kurzversion (BIS-15)
* Allgemeine Depressionsskala (ADS)
* State-Trait-Anxiety Inventory (STAI-T)
* Alcohol Use Disorders Identification Test (AUDIT)
* Cannabis Use Disorder Identification Test (CUDIT)
* CAS -A (Alkohol)
* Fragebogen zur Sozialen Unterstützung (F-SozU K-14)
* Oslo-3-Items-Social-Support Scale
* Social Skills Rating System (SSRS)
* Trier Inventory for chronic stress (TICS)
* Rejection Sensitivity Questionnaires (RSQ-9)
* Need to belong scale (NTBS)
* Fragebogen zu Gedanken und Gefühlen (FGG-14)
* Internationale Trauma Questionnaire (ITQ)
* Zahlen-Symbol-Test (DST)
* Wortschatztest (verbal intelligence)
pre and post cyberball task
Positive and Negative Affect Schedule(PANAS)
VAS
subjective arousal, subjective stress, valence, perceived ostracisms/loneliness
after cyberball task
* Need Threat Scale
* Manipulation check (VAS scale)
social inclusion (Cyberball task)
Social inclusion will be assessed using the cyberball paradigm: subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social inclusion, ball tosses will be balanced between all three players.
Moderate to sever alcohol users (AUD) - inclusion first
Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD) Cyberball: Inclusion Day 1; Cyberball: Exclusion Day 2
PIT paradigm
The paradigm consists of four parts:
In the first part, an instrumental learning task is completed in which subjects must learn which stimuli require a response and which do not. In the second part, a classical (Pavlovian) conditioning task is then completed in which subjects learn by passive viewing which stimuli are associated with certain amounts of money. The third part measures to which instrumental responses (learned in Part 1) are modulated by the presentation of the classically conditioned stimuli (learned in Part 2). At the same time drug-associated stimuli are presented in the background measuring to which extent they conflict with the learned instrumental behavior. In the last part, query trials are implemented in which the participants have to choose between two pictures to assess the relative cue value.
social exclusion (Cyberball task)
Social exclusion will be assessed using the cyberball paradigm: subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player, and during social inclusion, ball tosses will be balanced between all three players.
Saliva samples
Assessing acute stress effects in AUD and HC subjects
basic psychological assessment
* Sociodemographics
* ASSIST
* Quantity Frequency: Alcohol, tobacco/e-cigarette, Cannabis \& other illegal drugs
* SCID: AUD criteria and tabak use disorder life time and last year \& acute depressive symptoms \& symptoms for Mania and psychotic disorder
* Edinburgh Handedness Inventory (EHI)
* Fagerström Test for Nicotine depend (FTND)
* Barratt Impulsiveness Scale - Kurzversion (BIS-15)
* Allgemeine Depressionsskala (ADS)
* State-Trait-Anxiety Inventory (STAI-T)
* Alcohol Use Disorders Identification Test (AUDIT)
* Cannabis Use Disorder Identification Test (CUDIT)
* CAS -A (Alkohol)
* Fragebogen zur Sozialen Unterstützung (F-SozU K-14)
* Oslo-3-Items-Social-Support Scale
* Social Skills Rating System (SSRS)
* Trier Inventory for chronic stress (TICS)
* Rejection Sensitivity Questionnaires (RSQ-9)
* Need to belong scale (NTBS)
* Fragebogen zu Gedanken und Gefühlen (FGG-14)
* Internationale Trauma Questionnaire (ITQ)
* Zahlen-Symbol-Test (DST)
* Wortschatztest (verbal intelligence)
pre and post cyberball task
Positive and Negative Affect Schedule(PANAS)
VAS
subjective arousal, subjective stress, valence, perceived ostracisms/loneliness
after cyberball task
* Need Threat Scale
* Manipulation check (VAS scale)
social inclusion (Cyberball task)
Social inclusion will be assessed using the cyberball paradigm: subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social inclusion, ball tosses will be balanced between all three players.
Interventions
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PIT paradigm
The paradigm consists of four parts:
In the first part, an instrumental learning task is completed in which subjects must learn which stimuli require a response and which do not. In the second part, a classical (Pavlovian) conditioning task is then completed in which subjects learn by passive viewing which stimuli are associated with certain amounts of money. The third part measures to which instrumental responses (learned in Part 1) are modulated by the presentation of the classically conditioned stimuli (learned in Part 2). At the same time drug-associated stimuli are presented in the background measuring to which extent they conflict with the learned instrumental behavior. In the last part, query trials are implemented in which the participants have to choose between two pictures to assess the relative cue value.
social exclusion (Cyberball task)
Social exclusion will be assessed using the cyberball paradigm: subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player, and during social inclusion, ball tosses will be balanced between all three players.
Saliva samples
Assessing acute stress effects in AUD and HC subjects
basic psychological assessment
* Sociodemographics
* ASSIST
* Quantity Frequency: Alcohol, tobacco/e-cigarette, Cannabis \& other illegal drugs
* SCID: AUD criteria and tabak use disorder life time and last year \& acute depressive symptoms \& symptoms for Mania and psychotic disorder
* Edinburgh Handedness Inventory (EHI)
* Fagerström Test for Nicotine depend (FTND)
* Barratt Impulsiveness Scale - Kurzversion (BIS-15)
* Allgemeine Depressionsskala (ADS)
* State-Trait-Anxiety Inventory (STAI-T)
* Alcohol Use Disorders Identification Test (AUDIT)
* Cannabis Use Disorder Identification Test (CUDIT)
* CAS -A (Alkohol)
* Fragebogen zur Sozialen Unterstützung (F-SozU K-14)
* Oslo-3-Items-Social-Support Scale
* Social Skills Rating System (SSRS)
* Trier Inventory for chronic stress (TICS)
* Rejection Sensitivity Questionnaires (RSQ-9)
* Need to belong scale (NTBS)
* Fragebogen zu Gedanken und Gefühlen (FGG-14)
* Internationale Trauma Questionnaire (ITQ)
* Zahlen-Symbol-Test (DST)
* Wortschatztest (verbal intelligence)
pre and post cyberball task
Positive and Negative Affect Schedule(PANAS)
VAS
subjective arousal, subjective stress, valence, perceived ostracisms/loneliness
after cyberball task
* Need Threat Scale
* Manipulation check (VAS scale)
social inclusion (Cyberball task)
Social inclusion will be assessed using the cyberball paradigm: subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social inclusion, ball tosses will be balanced between all three players.
Eligibility Criteria
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Inclusion Criteria
* AUD subjects: meet 4 or more criteria for DSM-5 alcohol-use disorder (not requiring withdrawal as assessed by an independent psychiatrist),
* Currently using alcohol without a desire for abstinence,
* Ability to consent to the study and complete the questionnaires.
* Sufficient language skills: German
* Availability between 3pm-6pm on 2 consecutive days,
* existing health insurance
Exclusion Criteria
* Currently meeting DSM-5 diagnostic criteria for depressive episode, suicidal ideation,
* History of traumatic brain injury or severe neurological disease (such as dementia, Parkinson's disease, multiple sclerosis)
* Pregnancy or breastfeeding,
* Ingestion of medications known to interact with the CNS in the 10-day period prior to study participation or less than 4 half-lives after last ingestion (rapid urine test),
* Color vision deficiency
18 Years
65 Years
ALL
Yes
Sponsors
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Heidelberg University
OTHER
Zentralinstitut für Seelische Gesundheit Mannheim
OTHER
Technische Universität Dresden
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
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Andreas Heinz
Prof., MD, PhD
Locations
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Charite - Universitätsmedizin Berlin
Berlin, , Germany
Countries
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Facility Contacts
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References
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Roayaee M, Rahman RA, Danziger M, Tudge L, Daedelow LS, Heinz A, Wustenberg T. [The others and I: How social interactions change the perception of other persons. The Cyberball paradigm and its indications in the migration context]. Fortschr Neurol Psychiatr. 2020 Feb;88(2):109-117. doi: 10.1055/a-1033-7304. Epub 2020 Feb 26. German.
Staebler K, Helbing E, Rosenbach C, Renneberg B. Rejection sensitivity and borderline personality disorder. Clin Psychol Psychother. 2011 Jul-Aug;18(4):275-83. doi: 10.1002/cpp.705. Epub 2010 May 25.
Other Identifiers
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40217046122
Identifier Type: -
Identifier Source: org_study_id
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