Back to resultsThe Relationship Between Social Anxiety and Anxious Thinking Styles
Primary Purpose
Social Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cognitive Bias Modification for Interpretation (CBM-I)
Sham Training Control Condition
Sponsored by
About this trial
This is an interventional basic science trial for Social Anxiety focused on measuring social anxiety, interpretation bias, cognitive bias modification
Eligibility Criteria
Inclusion Criteria: Provides informed consent Sufficient German language skills to complete the experimental tasks and questionnaires Aged between 18 and 65 years Scoring ≥ 52 on the SPAI-G (Turner et al., 1989; Fydrich, 2016), indicating elevated levels of social anxiety Lives within reasonable travelling distance of the research centre Exclusion Criteria: Current psychotherapeutic treatment or psychotherapeutic treatment completed within the last 6 months prior to study enrolment. Current substance misuse or dependency (apart from Nicotine) Acute suicidality or self-harm Symptoms of a psychotic or bipolar disorder Presence of a somatic condition that could systematically affect cortisol levels (in particular: Pregnancy and lactation, adrenal dysfunction, thyroid dysfunction, pituitary dysfunction) Presence of a somatic condition that could systematically affect brain physiology (current or anamnestic neurological disorders, in particular: anamnestic traumatic brain injury, epilepsy, multiple sclerosis, brain tumors) Presence of a somatic condition that could systematically affect peripheral physiological measures (in particular: cardiovascular diseases (e.g., cardiac arrhythmias, circulatory diseases [e.g., hypertension])) Sensitivity or alteration of skin surface providing contraindication for EEG or periphysiological measures (in particular: baldness, dreadlocks, open wounds on the head or facial surface, skin conditions that cause particular sensitivity to gels and creams) Intake of psychotropic medication that cannot be interrupted during study duration or change in psychotropic medication within the 8 weeks before starting the study (except: antidepressants in unaltered dosage) Left handedness
Sites / Locations
- Mental Health Research and Treatment Center, Ruhr University of BochumRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Cognitive Bias Modification for Interpretation (CBM-I)
Sham Training Control Condition
Arm Description
Participants in this arm complete an initial introductory session of Cognitive Bias Modification for Interpretation (CBM-I) in the lab followed by 6 sessions scheduled to be completed over the subsequent week (1 per day). CBM-I will be administered via an online platform using an individual login account.
Participants in this arm complete an initial introductory session of the sham training control condition in the lab followed by 6 sessions scheduled to be completed over the subsequent week (1 per day). CBM-I will be administered via an online platform using an individual login account.
Outcomes
Primary Outcome Measures
Change from baseline to follow-up (2 weeks post-baseline) in score on the Liebowitz Social Anxiety Scale, Self-Report (LSAS-SR)
A 24-item self-report scale assessing social anxiety symptoms over the past 7 days (Consbruch, Stangier & Heidenreich, 2016; Liebowitz, 1987). Possible scores range from 0 (minimum) to 144 (maximum), with higher scores reflecting higher levels of social anxiety (i.e. worse outcomes). The primary outcome measure is change in score on the LSAS-SR from baseline to follow-up.
Secondary Outcome Measures
Liebowitz Social Anxiety Scale, Self-Report (LSAS-SR)
A 24-item self-report scale assessing social anxiety symptoms over the past 7 days (Consbruch, Stangier & Heidenreich, 2016; Liebowitz, 1987). Possible scores range from 0 (minimum) to 144 (maximum), with higher scores reflecting higher levels of social anxiety (i.e. worse outcomes).
Social Phobia and Anxiety Inventory, German version (SPAI-G)
A 22-item self-report scale used for screening different levels of social anxiety (Turner et al., 1989; Fydrich, 2016). Possible scores range from 0 (minimum) to 132 (maximum), with higher scores reflecting higher levels of social anxiety (i.e. worse outcomes).
Depression, Anxiety, and Stress Scale-21 (DASS)
A 21-item self-report questionnaire assessing symptoms of depression, stress and anxiety (7 items per subscale) over the past week (Lovibond & Lovibond, 1995; Nilges & Essau, 2015). Possible scores on each subscale range from 0 (minimum) to 21 (maximum), with higher scores reflecting higher levels of symptoms (i.e. worse outcomes).
Brief Fear of Negative Evaluation Scale (BFNE)
A 12-item self-report scale used to assess fear of being negatively evaluated by others in social situations (Leary, 1983; Reichenberger, Schwarz, König, Wilhelm, .. & Blechert, 2016). Possible scores range from 12 (minimum) to 60 (maximum), with higher scores reflecting higher levels of fear (i.e. worse outcomes).
Encoding Recognition Task (ERT)
The ERT is a 10-item computerized measure of interpretation bias (Salemink & van den Hout, 2010). Four versions are used, applied in a counterbalanced order across participants.
Scenario Rating Task (SRT)
The SRT is used to assess interpretation biases and their neurophysiological correlates via EEG (N400). Participants read ambiguous scenarios (i.e., sentence stems) that are completed by either congruent or incongruent endings, and have to rate how well the endings complete the sentence stems. Participants will be presented with a total of 96 trials, 48 of which are neutral and 48 of which are social anxiety-related. In addition to behavioural responses, the N400 amplitude will be measured via EEG in the 300-450 ms time window post-stimulus onset (i.e., the target word, e.g., Feng et al., 2019; Moser et al., 2008).
Anagram Task
The Anagram task is used to investigate stress reactivity towards social-evaluative threats in performance situations (Van Bockstaele et al., 2020). During the Anagram Task, heart rate, heart rate variability, and corrugator activity will be recorded. The state mood ratings (listed below) are used to measure mood response to the task.
Salivary cortisol
Salivary concentrations of cortisol will be collected during both lab assessments. During the first lab assessment, it will be collected once at baseline prior to the administration of the questionnaires. During the second lab assessment, it will be collected four times, at baseline prior to the administration of the questionnaires, pre-Anagram Task, post-Anagram task, post-Anagram task+25 min.
Salivary alpha-amylase
Salivary concentrations alpha-amylase will be collected during both lab assessments. During the first lab assessment, it will be collected once at baseline prior to the administration of the questionnaires. During the second lab assessment, it will be collected four times, at baseline prior to the administration of the questionnaires, pre-Anagram Task, post-Anagram task, post-Anagram task+25 min.
Frontal Asymmetry
Following Moscovitch et al. (2011), resting frontal alpha asymmetry will be recorded using EEG during an 8-minute resting period (in alternating 1-min eyes-open/eyes-closed segments) at both pre- and post-training. In addition, frontal assymetry will be recorded during the SRT, i.e., when presenting the ambiguous stems.
Full Information
NCT ID
NCT05798078
First Posted
March 22, 2023
Last Updated
May 14, 2023
Sponsor
Ruhr University of Bochum
Collaborators
Utrecht University, University of Osnabrueck
1. Study Identification
Unique Protocol Identification Number
NCT05798078
Brief Title
The Relationship Between Social Anxiety and Anxious Thinking Styles
Official Title
The Relationship Between Social Anxiety and Anxious Thinking Styles
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum
Collaborators
Utrecht University, University of Osnabrueck
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to investigate whether reductions in negative interpretation biases, induced via an experimental manipulation (Cognitive Bias Modification for Interpretation; CBM-I), lead to reductions in symptoms of social anxiety amongst individuals experiencing high levels of social anxiety. The study further aims to investigate the relationship between multifaceted measures of interpretation bias, psychopathological symptoms, neurophysiological indices, behavioral indices of stress reactivity, and SAD symptoms.
To achieve these aims a sample of individuals experiencing high levels of social anxiety will be recruited. After completing multi-faceted measures of interpretation bias, including neurophysiological indices, participants will be randomized to complete an online one-week daily CBM-I or sham training control condition training schedule. Following the one week training, individuals will return to the lab to complete further multi-faceted measures of interpretation bias and social anxiety symptoms. One week after this (i.e. 2 weeks post-basline), participants will complete a final set of symptom and bias measures online.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety
Keywords
social anxiety, interpretation bias, cognitive bias modification
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants are blind as to whether they have been allocated to the active training condition or sham training condition.
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Bias Modification for Interpretation (CBM-I)
Arm Type
Experimental
Arm Description
Participants in this arm complete an initial introductory session of Cognitive Bias Modification for Interpretation (CBM-I) in the lab followed by 6 sessions scheduled to be completed over the subsequent week (1 per day). CBM-I will be administered via an online platform using an individual login account.
Arm Title
Sham Training Control Condition
Arm Type
Sham Comparator
Arm Description
Participants in this arm complete an initial introductory session of the sham training control condition in the lab followed by 6 sessions scheduled to be completed over the subsequent week (1 per day). CBM-I will be administered via an online platform using an individual login account.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Bias Modification for Interpretation (CBM-I)
Intervention Description
The CBM-I intervention is based on the interpretation training paradigm developed by Mathews and Mackintosh (2000). It comprises a series of training scenarios describing different (mostly everyday) socially-relevant situations, structured so they start ambiguously but always have a positive ending. The positive ending is presented as word fragment, which participants are instructure to complete. In about 25% of trials, participants are further requested to respond to comprehension questions about the scenario presented. Each CBM-I session comprises 45 trials presented in 5 blocks of 9 scenarios.
Intervention Type
Behavioral
Intervention Name(s)
Sham Training Control Condition
Intervention Description
The sham training is in an identical format to the CBM-I training, except that the scenarios are all entirely neutral, with no reference to social situations and no emotional ambiguity.
Primary Outcome Measure Information:
Title
Change from baseline to follow-up (2 weeks post-baseline) in score on the Liebowitz Social Anxiety Scale, Self-Report (LSAS-SR)
Description
A 24-item self-report scale assessing social anxiety symptoms over the past 7 days (Consbruch, Stangier & Heidenreich, 2016; Liebowitz, 1987). Possible scores range from 0 (minimum) to 144 (maximum), with higher scores reflecting higher levels of social anxiety (i.e. worse outcomes). The primary outcome measure is change in score on the LSAS-SR from baseline to follow-up.
Time Frame
Baseline, Follow-up (2 weeks post-baseline)
Secondary Outcome Measure Information:
Title
Liebowitz Social Anxiety Scale, Self-Report (LSAS-SR)
Description
A 24-item self-report scale assessing social anxiety symptoms over the past 7 days (Consbruch, Stangier & Heidenreich, 2016; Liebowitz, 1987). Possible scores range from 0 (minimum) to 144 (maximum), with higher scores reflecting higher levels of social anxiety (i.e. worse outcomes).
Time Frame
Post-training (1 week post-baseline)
Title
Social Phobia and Anxiety Inventory, German version (SPAI-G)
Description
A 22-item self-report scale used for screening different levels of social anxiety (Turner et al., 1989; Fydrich, 2016). Possible scores range from 0 (minimum) to 132 (maximum), with higher scores reflecting higher levels of social anxiety (i.e. worse outcomes).
Time Frame
Screening, Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)
Title
Depression, Anxiety, and Stress Scale-21 (DASS)
Description
A 21-item self-report questionnaire assessing symptoms of depression, stress and anxiety (7 items per subscale) over the past week (Lovibond & Lovibond, 1995; Nilges & Essau, 2015). Possible scores on each subscale range from 0 (minimum) to 21 (maximum), with higher scores reflecting higher levels of symptoms (i.e. worse outcomes).
Time Frame
Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)
Title
Brief Fear of Negative Evaluation Scale (BFNE)
Description
A 12-item self-report scale used to assess fear of being negatively evaluated by others in social situations (Leary, 1983; Reichenberger, Schwarz, König, Wilhelm, .. & Blechert, 2016). Possible scores range from 12 (minimum) to 60 (maximum), with higher scores reflecting higher levels of fear (i.e. worse outcomes).
Time Frame
Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)
Title
Encoding Recognition Task (ERT)
Description
The ERT is a 10-item computerized measure of interpretation bias (Salemink & van den Hout, 2010). Four versions are used, applied in a counterbalanced order across participants.
Time Frame
Baseline, After last intervention session (~6 days post-baseline), Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)
Title
Scenario Rating Task (SRT)
Description
The SRT is used to assess interpretation biases and their neurophysiological correlates via EEG (N400). Participants read ambiguous scenarios (i.e., sentence stems) that are completed by either congruent or incongruent endings, and have to rate how well the endings complete the sentence stems. Participants will be presented with a total of 96 trials, 48 of which are neutral and 48 of which are social anxiety-related. In addition to behavioural responses, the N400 amplitude will be measured via EEG in the 300-450 ms time window post-stimulus onset (i.e., the target word, e.g., Feng et al., 2019; Moser et al., 2008).
Time Frame
Baseline, Post-training (1 week post-baseline)
Title
Anagram Task
Description
The Anagram task is used to investigate stress reactivity towards social-evaluative threats in performance situations (Van Bockstaele et al., 2020). During the Anagram Task, heart rate, heart rate variability, and corrugator activity will be recorded. The state mood ratings (listed below) are used to measure mood response to the task.
Time Frame
Post-training (1 week post-baseline)
Title
Salivary cortisol
Description
Salivary concentrations of cortisol will be collected during both lab assessments. During the first lab assessment, it will be collected once at baseline prior to the administration of the questionnaires. During the second lab assessment, it will be collected four times, at baseline prior to the administration of the questionnaires, pre-Anagram Task, post-Anagram task, post-Anagram task+25 min.
Time Frame
Baseline, Post-training (1 week post-baseline)
Title
Salivary alpha-amylase
Description
Salivary concentrations alpha-amylase will be collected during both lab assessments. During the first lab assessment, it will be collected once at baseline prior to the administration of the questionnaires. During the second lab assessment, it will be collected four times, at baseline prior to the administration of the questionnaires, pre-Anagram Task, post-Anagram task, post-Anagram task+25 min.
Time Frame
Baseline, Post-training (1 week post-baseline)
Title
Frontal Asymmetry
Description
Following Moscovitch et al. (2011), resting frontal alpha asymmetry will be recorded using EEG during an 8-minute resting period (in alternating 1-min eyes-open/eyes-closed segments) at both pre- and post-training. In addition, frontal assymetry will be recorded during the SRT, i.e., when presenting the ambiguous stems.
Time Frame
Baseline, Post-training (1 week post-baseline)
Other Pre-specified Outcome Measures:
Title
Expectancy Questionnaire (EQ)
Description
Expectancy effects will be assessed prior to training using the three expectancy items from the Credibility and Expectancy Questionnaire (Borkovec & Mathews, 1988). A total score is made by standardizing (z-transforming) the three items and adding the z-transformed scores together (i.e. no minimum or maximum scores). Higher scores indicate higher expectancy of improvement.
Time Frame
Baseline
Title
Feedback Questionnaire
Description
A questionnaire asking for feedback about the CBM/Sham intervention will be used, adapted from Woud et al. (2021). Each individual item is interpreted separately (i.e. no sum score is created).
Time Frame
Follow-up (2 weeks post-baseline)
Title
Negative Effects Questionnaire (NEQ)
Description
The short (20-item) version of the Negative Effects Questionnaire (Rozental et al., 2019) will be used to assess potential negative effects and adverse events linked to the study. The scale will be adapted for the purpose of the study with terms like 'therapy' and 'therapist' changed to e.g. 'study' and 'researchers' (as per Blackwell et al., 2022). The number of reported negative effects for each category are summed for reporting purposes.
Time Frame
Follow-up (2 weeks post-baseline)
Title
State affect
Description
State affect will be measured repeatedly throughout the assessment sessions (i.e., at baseline, pre-stressor, post-stressor, during and after the recovery phase) using a 7-item scale developed by Becker et al. (2016). This scale includes the following items: "I feel… tense / sad / anxious / confident / relaxed / happy / relieved", with each item being judged via a 5-point Likert scale.
Time Frame
Baseline, Post-training (1 week post-training)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Provides informed consent
Sufficient German language skills to complete the experimental tasks and questionnaires
Aged between 18 and 65 years
Scoring ≥ 52 on the SPAI-G (Turner et al., 1989; Fydrich, 2016), indicating elevated levels of social anxiety
Lives within reasonable travelling distance of the research centre
Exclusion Criteria:
Current psychotherapeutic treatment or psychotherapeutic treatment completed within the last 6 months prior to study enrolment.
Current substance misuse or dependency (apart from Nicotine)
Acute suicidality or self-harm
Symptoms of a psychotic or bipolar disorder
Presence of a somatic condition that could systematically affect cortisol levels (in particular: Pregnancy and lactation, adrenal dysfunction, thyroid dysfunction, pituitary dysfunction)
Presence of a somatic condition that could systematically affect brain physiology (current or anamnestic neurological disorders, in particular: anamnestic traumatic brain injury, epilepsy, multiple sclerosis, brain tumors)
Presence of a somatic condition that could systematically affect peripheral physiological measures (in particular: cardiovascular diseases (e.g., cardiac arrhythmias, circulatory diseases [e.g., hypertension]))
Sensitivity or alteration of skin surface providing contraindication for EEG or periphysiological measures (in particular: baldness, dreadlocks, open wounds on the head or facial surface, skin conditions that cause particular sensitivity to gels and creams)
Intake of psychotropic medication that cannot be interrupted during study duration or change in psychotropic medication within the 8 weeks before starting the study (except: antidepressants in unaltered dosage)
Left handedness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcella L Woud, PhD
Phone
+49 (0)234 32 - 21502
Email
marcella.woud@rub.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcella L Woud, PhD
Organizational Affiliation
Ruhr University of Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Research and Treatment Center, Ruhr University of Bochum
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcella L Woud, PhD
Phone
+49 (0)234 32 - 21502
Email
marcella.woud@rub.de
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymised data will be made available on publication via a suitable repository such as the Open Science Framework, and will be made available to reviewers at the time of submission (or publically with a pre-print version of the manuscript). Data made available will be the research data reported in the publication, withthe exception of any data that could compromise participant anonymity.
IPD Sharing Time Frame
Supporting information will be made available on publication via a suitable repository such as the Open Science Framework, and will be made available to reviewers at the time of submission (or publically with a pre-print version of the manuscript).
IPD Sharing URL
https://osf.io/e254p/
Learn more about this trial
The Relationship Between Social Anxiety and Anxious Thinking Styles
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