Augmentation of Exposure Using Positive Mental Rehearsal in Individuals With Increased Social Anxiety
NCT Number: NCT06564402
Acronym: APEX
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Social Anxiety|Social Phobia
Interventions: BEHAVIORAL: Positive Mental Rehearsal|BEHAVIORAL: Mental Rehearsal|BEHAVIORAL: Exposure
Sponsor: Philipps University Marburg Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-05-28
Completion Date: 2025-07-01
Locations: Germany Philipps University, Marburg, 35037, Germany

Summary:
Efficacy of an optimized exposure therapy training is investigated in individuals with heightened social anxiety. Participants will undergo a one-session standardized exposure training, followed by either standard or positive mental rehearsal of the exposure experience. The efficacy is measured by symptom improvement according to subjective ratings one week later.

Primary Outcome Measures: Social Interaction Anxiety Scale (SIAS), 20-item questionnaire on a 5-point Likert scale (0 = 'not at all'; 4 = 'very strongly') assessing severity of anxiety experienced in social interactions and situations. Total score range: 0 to 80. Higher scores indicate higher severity of social anxiety., Change from baseline to post-treatment (i.e., 7-9 days)|Liebowitz Social Anxiety Scale (LSAS), 2-items from the Liebowitz Social Anxiety Scale (LSAS) on a 4-point Likert scale (fear: 0 = 'none'; 3 = 'high'; avoidance: 0 = 'never'; 3 = 'usually') assessing fear and avoidance of the in the intervention exposed situations. Higher scores indicating greater level of fear and avoidance., Change from baseline to post-treatment (i.e., 7-9 days)|Communication Anxiety Inventory (CAI) - Trait Version, 21-item questionnaire on a 4-point Likert scale (0 = 'almost never'; 3 = 'almost always') assessing an individual's general level of anxiety in communication situations. Total range score: 0 to 84. Higher scores indicate greater level of communication anxiety., Change from baseline to post-treatment (i.e., 7-9 days)
Secondary Outcome Measures: Communication Anxiety Inventory (CAI) - State Version, 20-item questionnaire on a 4-point Likert scale (0 = 'not at all'; 3 = 'very strongly' assessing an individual's level of anxiety related to a specific communication situation., Baseline|Positive and Negative Affect Schedule (PANAS), 20-item questionnaire on a 5-point Likert scale (0 = 'not at all'; 4 = 'extremely' assessing the presence and intensity of both positive and negative emotions. Total score range for positive affect (PA) and negative affect (NA), respectively: 0 to 50. Higher scores indicate on either scale indicate a higher level of that emotion., Change from baseline to post-treatment (i.e., 7-9 days)|Post-Event Processing Inventory (PEPI) - Trait Version, 12-item questionnaire on a 5-point Likert scale (0 = 'strongly disagree; 4 = 'strongly agree') assessing an individual's general tendency to engage in post-event processing. Total score range: 0 to 60. Higher total scores indicate a greater tendency to ruminate or engage in negative post-event processing., Change from baseline to post-treatment (i.e., 7-9 days)|Post-Event Processing Inventory (PEPI) - State Version, 12-item questionnaire on a 5-point Likert scale (0 = 'strongly disagree; 4 = 'strongly agree') assessing an individual's level of rumination or post-event processing related to a specific context/situation. Total score range: 0 to 60. Higher total scores indicate a greater engagement in rumination and post-event processing., Post-treatment|Plymouth Sensory Imagery Questionnaire (PSI-Q), 21-item questionnaire across five modalities (visual, auditory, olfactory, gustatory, tactile, and kinesthetic imagery) on a 10-point Likert scale (0 = 'not at all'; 9 = 'mental image as clear and vivid as in real life') assessing how intensively and in detail people can imagine sensory experiences in their mind. Total score range: 0 to 210. Higher total scores indicate a more vivid and detailed sensory imagination., Baseline|Snaith-Hamilton-Pleasure-Scale (SHAPS), 14-item questionnaire on a 4-point Likert scale (0 = 'strongly disagree'; 3 = 'strongly agree') measuring anhedonia. Scores are transformed to a dichotomous scale: 0 = absence of anhedonia; 1 = presence of anhedonia). Total score range: 0 to 14. Higher total scores indicate greater levels of anhedonia., Change from baseline to post-treatment (i.e., 7-9 days)