NCT Number: NCT06564402
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Marburg, 35037, Germany
Location status: Recruiting
Andrea Stoliarov, M.Sc.
CONTACT
Andrea Stoliarov, M.Sc.
PRINCIPAL_INVESTIGATOR
Christiane Melzig, PhD
PRINCIPAL_INVESTIGATOR
Christoph Benke, PhD
CONTACT
Christoph Benke, PhD
PRINCIPAL_INVESTIGATOR
Exposure therapy is widely recognized as the gold-standard treatment for anxiety disorders, but its clinically significant response rates remain around 50%. Thus, innovative approaches are needed to improve the efficacy of exposure therapy. One strategy is the mental rehearsal of exposure treatment as a way of supporting the retrieval and consolidation of the exposure memory, which has been demonstrated to be an effective supplement to exposure therapy in a recent study. New conceptualizations also emphasize the role of reward processing and its importance in extinction learning. Several strategies have been proposed to target these reward processes to improve the outcomes of exposure therapy. The present study will examine the use of a positive-focused rehearsal strategy. Participants in the optimized exposure group will engage in an imaginal recounting task focusing on the positive aspects (i.e. emotions, thoughts, behavior) of the exposure. Rehearsal of the positive aspects may increase positive affect, with positive mood thought to be associated with deeper mental rehearsal of stored information. Therefore, the efficacy of using positive mental rehearsal (i.e., imaginal recounting) post-exposure will be investigated, with the use of standard mental rehearsal as an active control group. Participants will be asked to repeat the rehearsal experience at home at two-day intervals. Post-treatment assessment will be conducted one week later. The study will be conducted on healthy participants with an elevated level of social anxiety. The aim of this randomized controlled trial in healthy individuals with increased social anxiety is to investigate whether optimized exposure training (exposure + positive mental rehearsal) is more effective in reducing fear of social interaction compared to an active control group (exposure + mental rehearsal).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After exposure trial, participants are asked about the positive aspects of their exposure experience (e.g., thoughts, feelings), based on which an imagination script is formulated and recounted
After exposure, participants are asked about what happened during the exposure experience and whether their central concerns/expected outcome actually occurred during exposure
All participants complete exposure exercises (i.e., talking on the phone and talking with a stranger) before positive mental rehearsal is executed
Time frame: Change from baseline to post-treatment (i.e., 7-9 days)
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.
Time frame: Change from baseline to post-treatment (i.e., 7-9 days)
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.
Time frame: Change from baseline to post-treatment (i.e., 7-9 days)
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.
Time frame: Baseline
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.
Time frame: Change from baseline to post-treatment (i.e., 7-9 days)
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.
Time frame: Change from baseline to post-treatment (i.e., 7-9 days)
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.
Time frame: Post-treatment
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.
Time frame: Baseline
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.
Time frame: Change from baseline to post-treatment (i.e., 7-9 days)
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.
Contact information is provided by the study sponsor or research team.
Andrea Stoliarov, M.Sc.
CONTACT
Christoph Benke, PhD
CONTACT
Philipps University Marburg
Other
Acronym: APEX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06977087
Anxiety Disorders, Mental Disorders
Marburg, Germany
View Trial DetailsNCT07009444
Anxiety Disorders, Mental Disorders
Marburg, Germany
View Trial DetailsNCT05302518
Anxiety Disorders, Mental Disorders
Odense C, Denmark/Region of Southern Denmark, Denmark
View Trial DetailsNCT03514225
Anxiety Disorders, Mental Disorders
Manchester, Greater Manchester, United Kingdom
View Trial Details