Clinical trial NCT05798078: The Relationship Between Social Anxiety and Anxious Thinking Styles
Official title: The Relationship Between Social Anxiety and Anxious Thinking Styles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Keywords: social anxiety
interpretation bias
cognitive bias modification
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: Utrecht University
name: University of Osnabrueck
First posted: 2023-04-04
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Change from baseline to follow-up (2 weeks post-baseline) in score on the Liebowitz Social Anxiety Scale, Self-Report (LSAS-SR)
timeFrame: Baseline, Follow-up (2 weeks post-baseline)
Secondary outcomes:
measure: Liebowitz Social Anxiety Scale, Self-Report (LSAS-SR)
timeFrame: Post-training (1 week post-baseline)
measure: Social Phobia and Anxiety Inventory, German version (SPAI-G)
timeFrame: Screening, Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)
measure: Depression, Anxiety, and Stress Scale-21 (DASS)
timeFrame: Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)
measure: Brief Fear of Negative Evaluation Scale (BFNE)
timeFrame: Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)
measure: Encoding Recognition Task (ERT)
timeFrame: Baseline, After last intervention session (~6 days post-baseline), Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)
measure: Scenario Rating Task (SRT)
timeFrame: Baseline, Post-training (1 week post-baseline)
measure: Anagram Task
timeFrame: Post-training (1 week post-baseline)
measure: Salivary cortisol
timeFrame: Baseline, Post-training (1 week post-baseline)
measure: Salivary alpha-amylase
timeFrame: Baseline, Post-training (1 week post-baseline)
measure: Frontal Asymmetry
timeFrame: Baseline, Post-training (1 week post-baseline)
Other outcomes:
measure: Expectancy Questionnaire (EQ)
timeFrame: Baseline
measure: Feedback Questionnaire
timeFrame: Follow-up (2 weeks post-baseline)
measure: Negative Effects Questionnaire (NEQ)
timeFrame: Follow-up (2 weeks post-baseline)
measure: State affect
timeFrame: Baseline, Post-training (1 week post-training)
Locations:
city: Bochum
country: Germany
facility: Mental Health Research and Treatment Center, Ruhr University of Bochum
Study officials:
affiliation: Ruhr University of Bochum
name: Marcella L Woud, PhD
role: PRINCIPAL_INVESTIGATOR
References: