The Relationship Between Social Anxiety and Anxious Thinking Styles

NCT05798078 | Completed

• 1 other identifier: 582
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety

Keywords

social anxiety; interpretation bias; cognitive bias modification

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Follow-up (2 weeks post-baseline)

Secondary Outcomes (10)

• Liebowitz Social Anxiety Scale, Self-Report (LSAS-SR)

  Post-training (1 week post-baseline)

• Social Phobia and Anxiety Inventory, German version (SPAI-G)

  Screening, Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)

• Depression, Anxiety, and Stress Scale-21 (DASS)

  Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)

• Brief Fear of Negative Evaluation Scale (BFNE)

  Baseline, Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)

• Encoding Recognition Task (ERT)

  Baseline, After last intervention session (~6 days post-baseline), Post-training (1 week post-baseline), Follow-up (2 weeks post-baseline)

Other Outcomes (4)

• Expectancy Questionnaire (EQ)

  Baseline

• Feedback Questionnaire

  Follow-up (2 weeks post-baseline)

• Negative Effects Questionnaire (NEQ)

  Follow-up (2 weeks post-baseline)

Study Arms (2)

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.

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.

Behavioral: Sham Training Control Condition

Interventions

Cognitive Bias Modification for Interpretation (CBM-I) BEHAVIORAL

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.

Cognitive Bias Modification for Interpretation (CBM-I)

Sham Training Control Condition BEHAVIORAL

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.

Sham Training Control Condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead
• Utrecht University: collaborator
• University of Osnabrueck: collaborator

Study Sites (1)

Mental Health Research and Treatment Center, Ruhr University of Bochum

Bochum, 44787, Germany

Location

Study Officials

• Marcella L Woud, PhD

  Ruhr University of Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blind as to whether they have been allocated to the active training condition or sham training condition.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Professor

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 4, 2023
• Study Start: May 16, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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).

Locations

DE (1)