NCT06258889

Brief Summary

The present study aims to examine whether the efficacy of an exposure treatment in individuals with public speaking anxiety can be enhanced by implementing interventions that target reward processes. Optimized exposure enriched with reward-focused interventions will be compared to exposure in combination with interventions targeting cognitive flexibility. The efficacy of the exposure training will be assessed by behavioural and self-report measures of public-speaking anxiety at baseline (before intervention), intermediate-assessment (7-9 days after baseline assessment) and post-assessment (at least 7-9 days after intermediate-assessment). The investigators expect that exposure optimized by implementing reward-focused interventions is more effective in reducing public speaking anxiety compared to exposure in combination with interventions targeting cognitive flexibility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2024

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2024

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

February 6, 2024

Last Update Submit

January 7, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Personal Report of Public Speaking Anxiety (PRPSA)

    34-item scale for measuring fear of public speaking, each item is rated on a 5-item Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Cronbach's alpha has been shown to range from 0.84 to 0.97. High scores on the scale reflect higher fear of public speaking

    Change from baseline to intermediate-assessment (i.e., 7-9 days later) to post assessment (i.e., at least 7 days after intermediate-assessment)

  • Behavioral Approach Test (BAT)

    Rated fear on a scale from 0 (no fear) to 100 (severe fear) during oral presentation.

    Change from baseline to intermediate-assessment (i.e., 7-9 days later) to post assessment (i.e., at least 7 days after intermediate-assessment)

Secondary Outcomes (4)

  • Temporal Experience of Pleasure Scale (TEPS)

    Change from baseline to intermediate-assessment (i.e., 7-9 days later) to post assessment (i.e., at least 7 days after intermediate-assessment)

  • Positive and Negative Affect Schedule (PANAS)

    Change from baseline to intermediate-assessment (i.e., 7-9 days later) to post assessment (i.e., at least 7 days after intermediate-assessment)

  • Social Phobia Scale (SPS)

    Change from baseline to intermediate-assessment (i.e., 7-9 days later) to post assessment (i.e., at least 7 days after intermediate-assessment)

  • Brief fear of negative evaluations (BFNE-R)

    Change from baseline to intermediate-assessment (i.e., 7-9 days later) to post assessment (i.e., at least 7 days after intermediate-assessment)

Study Arms (2)

reward-focused intervention + exposure

EXPERIMENTAL

Psychoeducation reward-focused interventions based on Positive Affect Treatment (Finding the silver lining, taking ownership, imagining the positive) Exposure \& reward-focused interventions before and after exposure trials

Behavioral: reward-focused interventionBehavioral: exposureBehavioral: Psychoeducation

Cognitive flexibility intervention + exposure

ACTIVE COMPARATOR

Psychoeducation Cognitive Flexibility based on Unified Protocol of emotional disorders Exposure \& cognitive flexibility interventions before and after exposure trials

Behavioral: cognitive flexibility interventionBehavioral: exposureBehavioral: Psychoeducation

Interventions

Participants complete three interventions based on the Positive Affect Treatment: * Finding the silver lining includes attending to and appreciating positive aspects of past events * Taking ownership includes identifying the personal behavioral contribution to rewarding past experiences * Imagining the positive includes training the prospective, positive imagination of future events Participants are asked to practice these interventions at least three times a week (approx. 15 mins each) until the next training session.

reward-focused intervention + exposure
exposureBEHAVIORAL

All participants undergo an exposure training session lasting approximately 90 minutes, which includes three exposure trial where participants give a speech, each lasting 5 minutes. Exposure exercises are enriched with interventions of the respective treatment group (either reward-focused or cognitive flexibility interventions).

Cognitive flexibility intervention + exposurereward-focused intervention + exposure

This training aims to promote cognitive flexibility in the context of public speaking situations. The intervention is based on the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. Participants will be trained to identify and modify non-adaptive thoughts occurring in the context of public speaking situations.

Cognitive flexibility intervention + exposure
PsychoeducationBEHAVIORAL

All participants received information on anxiety, and the maintenance of anxiety as well as a rationale for the exposure session.

Cognitive flexibility intervention + exposurereward-focused intervention + exposure

Eligibility Criteria

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

You may qualify if:

  • Proficient in the German language.
  • Elevated levels of anxiety and avoidance of public speaking situations as indicated by a score of \> 5 and \> 4, respectively, on a scale from 0 to 8 using the following items:
  • How anxious would you feel giving a formal speech before a live audience? How likely would you be to avoid taking a class that required taking an oral presentation?

You may not qualify if:

  • severe cardiovascular, respiratory or neurological diseases
  • current psychotherapeutic/psychiatric treatment
  • Intention to start psychotherapeutic/psychiatric treatment
  • current suicidal ideations
  • psychotic symptoms (lifetime)
  • current psychopharmacological medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philipps-University Marburg

Marburg, Hesse, 35032, Germany

Location

Related Publications (3)

  • Craske MG, Meuret AE, Ritz T, Treanor M, Dour HJ. Treatment for Anhedonia: A Neuroscience Driven Approach. Depress Anxiety. 2016 Oct;33(10):927-938. doi: 10.1002/da.22490.

    PMID: 27699943BACKGROUND
  • 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
  • Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164.

    PMID: 28768327BACKGROUND

MeSH Terms

Conditions

Glossophobia

Study Officials

  • Christoph Benke, PhD

    Philipps University Marburg

    PRINCIPAL INVESTIGATOR
  • Anton Regorius, PhD

    Philipps University Marburg

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 14, 2024

Study Start

January 8, 2024

Primary Completion

December 13, 2024

Study Completion

December 13, 2024

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations