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Recruiting NCT06564402

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

No phase Interventional Social Anxiety Social Phobia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Positive Mental Rehearsal, Mental Rehearsal, Exposure.
Who it may be relevant to
Registry conditions: Social Anxiety, Social Phobia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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).

Interventions

  • 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 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
  • Behavioral Exposure
    All participants complete exposure exercises (i.e., talking on the phone and talking with a stranger) before positive mental rehearsal is executed

Primary outcome measures

  • Social Interaction Anxiety Scale (SIAS) [Time frame: 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)]
  • Communication Anxiety Inventory (CAI) - Trait Version [Time frame: Change from baseline to post-treatment (i.e., 7-9 days)]
Secondary outcome measures (6)
  • Communication Anxiety Inventory (CAI) - State Version [Time frame: Baseline]
  • Positive and Negative Affect Schedule (PANAS) [Time frame: 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)]
  • Post-Event Processing Inventory (PEPI) - State Version [Time frame: Post-treatment]
  • Plymouth Sensory Imagery Questionnaire (PSI-Q) [Time frame: Baseline]
  • Snaith-Hamilton-Pleasure-Scale (SHAPS) [Time frame: Change from baseline to post-treatment (i.e., 7-9 days)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Germany Philipps University — Marburg

Publications

  • Rosenberg BM, Barnes-Horowitz NM, Zbozinek TD, Craske MG. Reward processes in extinction learning and applications to exposure therapy. J Anxiety Disord. 2024 Aug;106:102911. doi: 10.1016/j.janxdis.2024.102911. Epub 2024 Jul 29. PMID 39128178
  • McGlade AL, Craske MG. Optimizing exposure: Between-session mental rehearsal as an augmentation strategy. Behav Res Ther. 2021 Apr;139:103827. doi: 10.1016/j.brat.2021.103827. Epub 2021 Feb 11. PMID 33607459
  • Craske MG, Meuret AE, Echiverri-Cohen A, Rosenfield D, Ritz T. Positive affect treatment targets reward sensitivity: A randomized controlled trial. J Consult Clin Psychol. 2023 Jun;91(6):350-366. doi: 10.1037/ccp0000805. Epub 2023 Mar 9. PMID 36892884
  • Craske MG, Meuret AE, Ritz T, Treanor M, Dour H, Rosenfield D. Positive affect treatment for depression and anxiety: A randomized clinical trial for a core feature of anhedonia. J Consult Clin Psychol. 2019 May;87(5):457-471. doi: 10.1037/ccp0000396. PMID 30998048

Identifiers

NCT: NCT06564402 · APEX_SOCIALANX

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗