NCT06564402

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

August 19, 2024

Last Update Submit

January 7, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Communication Anxiety Inventory (CAI) - State Version

    Baseline

  • Positive and Negative Affect Schedule (PANAS)

    Change from baseline to post-treatment (i.e., 7-9 days)

  • Post-Event Processing Inventory (PEPI) - Trait Version

    Change from baseline to post-treatment (i.e., 7-9 days)

  • Post-Event Processing Inventory (PEPI) - State Version

    Post-treatment

  • Plymouth Sensory Imagery Questionnaire (PSI-Q)

    Baseline

  • +1 more secondary outcomes

Study Arms (2)

Exposure + Positive Mental Rehearsal

EXPERIMENTAL

Mental rehearsal of the positive aspects of exposure experience

Behavioral: Positive Mental RehearsalBehavioral: Exposure

Exposure + Mental rehearsal

ACTIVE COMPARATOR

Mental rehearsal of the exposure experience

Behavioral: Mental RehearsalBehavioral: Exposure

Interventions

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

Exposure + Positive 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

Exposure + Mental rehearsal
ExposureBEHAVIORAL

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

Exposure + Mental rehearsalExposure + Positive Mental Rehearsal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Germany Philipps University

Marburg, 35037, Germany

RECRUITING

Related Publications (4)

  • 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: 39128178BACKGROUND
  • 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: 33607459BACKGROUND
  • 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: 36892884BACKGROUND
  • 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: 30998048BACKGROUND

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 21, 2024

Study Start

May 28, 2024

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations