Augmentation of Exposure Using Positive Mental Rehearsal in Individuals With Increased Social Anxiety (APEX)

January 7, 2026 updated by: Christoph Benke, Philipps University Marburg
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Marburg, Germany, 35037
        • Recruiting
        • Germany Philipps University
        • Contact:
        • Principal Investigator:
          • Christoph Benke, PhD
        • Contact:
        • Principal Investigator:
          • Christiane Melzig, PhD
        • Principal Investigator:
          • Andrea Stoliarov, M.Sc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Elevated score on Social Interactions Anxiety Scale (SIAS) > 26

Exclusion Criteria:

  • Current psychotherapeutic/psychiatric treatment
  • Plans to start psychotherapeutic/psychiatric treatment in upcoming weeks
  • Current suicidal intent
  • Severe cardiovascular, respiratory or neurological diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exposure + Positive Mental Rehearsal
Mental rehearsal of the positive aspects of exposure experience
Behavioral: Positive Mental Rehearsal
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
Behavioral: Exposure
All participants complete exposure exercises (i.e., talking on the phone and talking with a stranger) before positive mental rehearsal is executed
Active Comparator: Exposure + Mental rehearsal
Mental rehearsal of the exposure experience
Behavioral: Exposure
All participants complete exposure exercises (i.e., talking on the phone and talking with a stranger) before positive mental rehearsal is executed
Behavioral: Mental Rehearsal
After exposure, participants are asked about what happened during the exposure experience and whether their central concerns/expected outcome actually occurred during exposure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Social Interaction Anxiety Scale (SIAS)
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.
Change from baseline to post-treatment (i.e., 7-9 days)
Liebowitz Social Anxiety Scale (LSAS)
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.
Change from baseline to post-treatment (i.e., 7-9 days)
Communication Anxiety Inventory (CAI) - Trait Version
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.
Change from baseline to post-treatment (i.e., 7-9 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Communication Anxiety Inventory (CAI) - State Version
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.
Baseline
Positive and Negative Affect Schedule (PANAS)
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.
Change from baseline to post-treatment (i.e., 7-9 days)
Post-Event Processing Inventory (PEPI) - Trait Version
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.
Change from baseline to post-treatment (i.e., 7-9 days)
Post-Event Processing Inventory (PEPI) - State Version
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.
Post-treatment
Plymouth Sensory Imagery Questionnaire (PSI-Q)
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.
Baseline
Snaith-Hamilton-Pleasure-Scale (SHAPS)
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.
Change from baseline to post-treatment (i.e., 7-9 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philipps University Marburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APEX_SOCIALANX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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