Clinical trial NCT06258889: Optimizing Exposure Therapy Via Reward-focused Interventions in Individuals with Public Speaking Anxiety
Official title: Optimizing Exposure Therapy Via Reward-focused Interventions: a Randomized Controlled Trial in Individuals with Public Speaking Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Public Speaking Fear
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The present study aims to investigate the efficacy of an optimized exposure training enriched with reward-focused interventions compared to exposure in combination with interventions targeting cognitive flexibility in individuals with elevated public speaking anxiety. Cognitive behavioral therapy offers effective methods for the treatment of various anxiety disorders. However, a substantial number of patients does not benefit from such treatments or experience a return of fear following successful treatment. Emerging evidence underscores the critical involvement of reward processes in fear extinction. Incorporating reward processes in exposure treatments might help to maximize treatment outcomes. In the present study, the investigators will apply reward-focused strategies prior to and during exposure. Strategies are selected to target the core reward processes (i.e., reward anticipation, attainment and learning). Interventions involve finding the silver lining, taking ownership and imagining the positive. Finding the silver lining mainly targets reward attainment (liking) by attending to and appreciating positive aspects of past events. Taking ownership targets liking and reward learning by identifying the personal behavioral contribution to rewarding past experiences. The intervention imagining the positive targets the anticipation of reward (wanting) by training the prospective, positive imagination of future events. The investigators will use an active control group, in which a training of cognitive flexibility (CF; Barlow et al., 2018) will be performed. This training aims to promote cognitive flexibility in the context of public speaking situations. Participants will be trained to identify and modify non-adaptive thoughts (e.g. catastrophizing thoughts). All participants first receive psychoeducation (information on public speaking anxiety, maintenance of anxiety, rationale of exposure training), followed by either reward-focused interventions (Finding the Silver Lining, Taking Ownership, Imagining the Positive) or the CF intervention. Following this session, participants will be asked to practice these interventions between sessions. After one week, exposure in combination with either reward-focused or cognitive flexibility strategies will be performed. Symptom improvement will be assessed at the baseline assessment (i.e., before interventions), at the intermediate-assessment (i.e., before the exposure sessions) and at post assessment (i.e., one week after the exposure sessions). The aim of this randomized controlled trial in individuals with elevated public speaking anxiety is to investigate whether the exposure combined with reward-focused interventions is more effective in reducing public speaking anxiety compared to extinction training combined with cognitive flexibility training.

Eligibility criteria: Inclusion Criteria:

* 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?

Exclusion Criteria:

* 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

Primary outcomes:
measure: Personal Report of Public Speaking Anxiety (PRPSA)
timeFrame: Change from baseline to intermediate-assessment (i.e., 7-9 days later) to post assessment (i.e., at least 7 days after intermediate-assessment)
measure: Behavioral Approach Test (BAT)
timeFrame: 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:
measure: Temporal Experience of Pleasure Scale (TEPS)
timeFrame: Change from baseline to intermediate-assessment (i.e., 7-9 days later) to post assessment (i.e., at least 7 days after intermediate-assessment)
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Change from baseline to intermediate-assessment (i.e., 7-9 days later) to post assessment (i.e., at least 7 days after intermediate-assessment)
measure: Social Phobia Scale (SPS)
timeFrame: Change from baseline to intermediate-assessment (i.e., 7-9 days later) to post assessment (i.e., at least 7 days after intermediate-assessment)
measure: Brief fear of negative evaluations (BFNE-R)
timeFrame: Change from baseline to intermediate-assessment (i.e., 7-9 days later) to post assessment (i.e., at least 7 days after intermediate-assessment)
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps-University Marburg
state: Hessen
Study officials:
affiliation: Philipps University Marburg
name: Christoph Benke, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Philipps University Marburg
name: Anton Regorius, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.