Social AnxietyNCT05798078
The Relationship Between Social Anxiety and Anxious Thinking Styles
A study testing Cognitive Bias Modification for Interpretation (CBM-I) in people with Social Anxiety, run by Ruhr University of Bochum at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Cognitive Bias Modification for Interpretation (CBM-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteGermany
- Study dates
- 16 May 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Mental Health Research and Treatment Center, Ruhr University of Bochum
Bochum, 44787
About this study
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.
- Conditions
- Social Anxiety
- Being tested
- Cognitive Bias Modification for Interpretation (CBM-I), Sham Training Control Condition
- Keywords
- social anxiety, interpretation bias, cognitive bias modification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Bias Modification for Interpretation (CBM-I)Behavioural
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.
Sham Training Control ConditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Bias Modification for Interpretation (CBM-I) | Experimental | 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. Receives: Behavioral: Cognitive Bias Modification for Interpretation (CBM-I) |
| Sham Training Control Condition | Sham comparator | 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. Receives: Behavioral: Sham Training Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Follow-up (2 weeks post-baseline)
Secondary outcomes (10)
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).
Measured: Post-training (1 week post-baseline)
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).
Measured: Screening, Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)
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).
Measured: Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)
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).
Measured: Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)
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.
Measured: Baseline, After last intervention session (~6 days post-baseline), Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)
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).
Measured: Baseline, Post-training (1 week post-baseline)
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.
Measured: Post-training (1 week post-baseline)
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.
Measured: Baseline, Post-training (1 week post-baseline)
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.
Measured: Baseline, Post-training (1 week post-baseline)
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.
Measured: Baseline, Post-training (1 week post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start16 May 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- Utrecht University, University of Osnabrueck
- Responsible party
- Principal investigator, Marcella Woud, Ruhr University of Bochum
- Investigators
- Marcella L Woud, PhD, Principal investigator, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798078
- Sponsor's protocol ID
- 582
- Status last verified
- Jun 2024
- First submitted
- 22 Mar 2023
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Social Anxiety and Anxious Thinking Styles
- ClinicalTrials.gov ID
- NCT05798078
- Acronym / sponsor ID
- 582
- Conditions
- Social Anxiety
- Keywords
- social anxiety, interpretation bias, cognitive bias modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Collaborators
- Utrecht University, University of Osnabrueck
- Study start
- 16 May 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Bias Modification for Interpretation (CBM-I) | Experimental | Behavioral: Cognitive Bias Modification for Interpretation (CBM-I)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. |
| Sham Training Control Condition | Sham comparator | Behavioral: Sham Training Control ConditionParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Bias Modification for Interpretation (CBM-I)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. | Behavioural | Cognitive Bias Modification for Interpretation (CBM-I) |
| Sham Training Control ConditionThe 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. | Behavioural | Sham Training Control Condition |
Primary outcome
Change from baseline to follow-up (2 weeks post-baseline) in score on the Liebowitz Social Anxiety Scale, Self-Report (LSAS-SR)
Time frame: Baseline, Follow-up (2 weeks post-baseline)
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.
10 secondary outcomes
Liebowitz Social Anxiety Scale, Self-Report (LSAS-SR)
Time frame: Post-training (1 week post-baseline)
Social Phobia and Anxiety Inventory, German version (SPAI-G)
Time frame: Screening, Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)
Depression, Anxiety, and Stress Scale-21 (DASS)
Time frame: Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)
Brief Fear of Negative Evaluation Scale (BFNE)
Time frame: Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)
Encoding Recognition Task (ERT)
Time frame: Baseline, After last intervention session (~6 days post-baseline), Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)
Scenario Rating Task (SRT)
Time frame: Baseline, Post-training (1 week post-baseline)
Anagram Task
Time frame: Post-training (1 week post-baseline)
Salivary cortisol
Time frame: Baseline, Post-training (1 week post-baseline)
Salivary alpha-amylase
Time frame: Baseline, Post-training (1 week post-baseline)
Frontal Asymmetry
Time frame: Baseline, Post-training (1 week post-baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcella L Woud, PhD principal investigator
Ruhr University of Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Bias Modification for Interpretation (CBM-I) in people with Social Anxiety, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to follow-up (2 weeks post-baseline) in score on the Liebowitz Social Anxiety Scale, Self-Report (LSAS-SR) (time frame: Baseline, Follow-up (2 weeks post-baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.