Reward Processing and Exposure Therapy for Social Anxiety Disorder

NCT06776991 | Recruiting

• 1 other identifier: 1K23MH133971-01A1
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators are conducting a clinical trial of therapy for public speaking anxiety. There are many eligibility criteria, but the main ones are that participants need to be socially anxious and have public speaking anxiety. In this clinical trial, all participants will do exposure therapy. Before doing exposure therapy in the study, though, participants will be randomized to do one of two treatments: i) a positive mood treatment, which is designed to increase how positive people feel, and ii) a relaxation treatment, which is designed to help people feel more relaxed. The investigators are doing this study to see whether doing the positive mood treatment or relaxation treatment first will affect how well exposure therapy works.

Conditions

Anhedonia; ANXIETY DISORDERS (or Anxiety and Phobic Neuroses); Phobic Disorders; Social Anxiety Disorder (Social Phobia); Public Speaking Anxiety

Keywords

Exposure Therapy; Anxiety; Social Anxiety; Public Speaking Anxiety; Anhedonia; Reward Processing; Inhibitory Retrieval; Positive Affect Treatment; Relaxation Treatment

Outcome Measures

Primary Outcomes (10)

• Public Speaking Anxiety Scale (PSAS)

  Self-reported public speaking anxiety symptom severity. This measure is a 17-item questionnaire using a 1-5 scale (1 = not at all, 3 = moderately, 5 = extremely) with sum scores ranging 17-83. Higher = worse.

  Pre Tx (week 0), Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6), Post Tx-2 (after Exposure Therapy) (~week 12), 3-Month Follow-Up (~week 24). Also Sessions 2, 4, 6, 8 of each therapy (corresponding to ~weeks 1, 2, 3, 4, 7, 8, 9, 10).

• Behavioral Approach Task - Anxiety

  Self-reported anxiety during public speaking Behavioral Approach Task. The Behavioral Approach Task is a task in which the participant gives a speech to a small audience (1-4 people) on a topic of the experimenter's choosing. One of four speech topics will be conducted (counterbalanced). The investigators will measure participants' anxiety throughout this task, including anxiety while anticipating the speech and delivering the speech. Anxiety will be measured "right now" on a 0-100 scale, where 0 = no anxiety, 50 = moderate, and 100 = extreme. Higher = worse.

  Pre Tx (week 0), Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6), Post Tx-2 (after Exposure Therapy) (~week 12), 3-Month Follow-Up (~week 24).

• Behavioral Approach Task - Likelihood Expectancy

  Self-reported likelihood that participant will be / was negatively socially evaluated during public speaking Behavioral Approach Task. The Behavioral Approach Task is a task in which the participant gives a speech to a small audience (1-4 people) on a topic of the experimenter's choosing. One of four speech topics will be conducted (counterbalanced). The investigators will measure participants' expectation that they will be negatively socially evaluated by the audience during the public speech. The investigators will measure this in anticipation of the speech (likelihood that the participant will be negatively socially evaluated) and after completing the speech (likelihood that the participant was negatively socially evaluated). Likelihood expectancy will be measured on a 0-100 scale, where 0 = certain they will not negatively evaluate you, 50 = completely uncertain, and 100 = certain they will negatively evaluate you. Higher = worse.

  Pre Tx (week 0), Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6), Post Tx-2 (after Exposure Therapy) (~week 12), 3-Month Follow-Up (~week 24).

• Behavioral Approach Task - Severity Expectancy

  Self-reported belief that, if participant will be / was negatively socially evaluated during public speaking Behavioral Approach Task, how severe do they think the negative social evaluation will be / was. The Behavioral Approach Task is a task in which the participant gives a speech to a small audience (1-4 people) on a topic of the experimenter's choosing. One of four speech topics will be conducted (counterbalanced). The investigators will measure participants' expectation that, if they are negatively socially evaluated by the audience during the public speech, how severe do they believe that severity will be / was. The investigators will measure this in anticipation of the speech (severity of negative social evaluation if it were to occur) and after completing the speech (severity of negative social evaluation if it did occur). Severity expectancy will be measured on a 0-100 scale, where 0 = not at all, 50 = moderate, and 100 = extreme. Higher = worse.

  Pre Tx (week 0), Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6), Post Tx-2 (after Exposure Therapy) (~week 12), 3-Month Follow-Up (~week 24).

• Behavioral Approach Task - Like/Dislike of Speech

  Self-reported liking/disliking of public speech. The Behavioral Approach Task is a task in which the participant gives a speech to a small audience (1-4 people) on a topic of the experimenter's choosing. One of four speech topics will be conducted (counterbalanced). After completing the speech, participants will rate how much they liked or disliked giving their public speech (-10 = dislike very much, 0 = neutral, +10 = like very much). Higher = better.

  Pre Tx (week 0), Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6), Post Tx-2 (after Exposure Therapy) (~week 12), 3-Month Follow-Up (~week 24).

• Behavioral Approach Task - Skin Conductance

  Skin conductance during Behavioral Approach Task. The Behavioral Approach Task is a task in which the participant gives a speech to a small audience (1-4 people) on a topic of the experimenter's choosing. One of four speech topics will be conducted (counterbalanced). Skin conductance is a physiological measure that will be analyzed during the speech anticipation period, where participants sit quietly for 2 minutes prior to giving their speech. The investigators will assess mean skin conductance level during this anticipation period minus their mean skin conductance level during a 2-minute baseline period prior to the speech task. Higher = worse.

  Pre Tx (week 0), Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6), Post Tx-2 (after Exposure Therapy) (~week 12), 3-Month Follow-Up (~week 24).

• Behavioral Approach Task - Electrocardiography HF-HRV

  Electrocardiography during Behavioral Approach Task. The Behavioral Approach Task is a task in which the participant gives a speech to a small audience (1-4 people) on a topic of the experimenter's choosing. One of four speech topics will be conducted (counterbalanced). Electrocardiography is a physiological measure that will be analyzed during the speech anticipation period, where participants sit quietly for 2 minutes prior to giving their speech. Using electrocardiography, the investigators will analyze high frequency heart rate variability (HF-HRV) during this anticipation period. Higher = better.

  Pre Tx (week 0), Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6), Post Tx-2 (after Exposure Therapy) (~week 12), 3-Month Follow-Up (~week 24).

• Behavioral Approach Task - Electrocardiography RMSSD HRV

  Electrocardiography during Behavioral Approach Task. The Behavioral Approach Task is a task in which the participant gives a speech to a small audience (1-4 people) on a topic of the experimenter's choosing. One of four speech topics will be conducted (counterbalanced). Electrocardiography is a physiological measure that will be analyzed during the speech anticipation period, where participants sit quietly for 2 minutes prior to giving their speech. Using electrocardiography, the investigators will analyze root mean square of successive differences (RMSSD) heart rate variability (HRV) during this anticipation period. Higher = better.

  Pre Tx (week 0), Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6), Post Tx-2 (after Exposure Therapy) (~week 12), 3-Month Follow-Up (~week 24).

• Behavioral Approach Task - Electrocardiography LF/HF-HRV

  Electrocardiography during Behavioral Approach Task. The Behavioral Approach Task is a task in which the participant gives a speech to a small audience (1-4 people) on a topic of the experimenter's choosing. One of four speech topics will be conducted (counterbalanced). Electrocardiography is a physiological measure that will be analyzed during the speech anticipation period, where participants sit quietly for 2 minutes prior to giving their speech. Using electrocardiography, the investigators will analyze low frequency divided by high frequency heart rate variability (LF/HF-HRV) during this anticipation period. Higher = worse.

  Pre Tx (week 0), Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6), Post Tx-2 (after Exposure Therapy) (~week 12), 3-Month Follow-Up (~week 24).

• Behavioral Approach Task - Speech Duration

  How long the participant delivers their speech (between 0 and 5 minutes). The Behavioral Approach Task is a task in which the participant gives a speech to a small audience (1-4 people) on a topic of the experimenter's choosing. One of four speech topics will be conducted (counterbalanced). Participants can stop their speech whenever they choose to do so (e.g., if feeling anxious). Speech duration is a behavioral measure. Higher = better.

  Pre Tx (week 0), Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6), Post Tx-2 (after Exposure Therapy) (~week 12), 3-Month Follow-Up (~week 24).

Secondary Outcomes (26)

• Liebowitz Social Anxiety Scale (LSAS)

  Pre Tx (week 0), Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6), Post Tx-2 (after Exposure Therapy) (~week 12), 3-Month Follow-Up (~week 24).

• Dimensional Anhedonia Rating Scale (DARS)

  Pre Tx (week 0), Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6), Post Tx-2 (after Exposure Therapy) (~week 12), 3-Month Follow-Up (~week 24).

• Depression, Anxiety, and Stress Scale (DASS-21)

  Pre Tx (week 0), Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6), Post Tx-2 (after Exposure Therapy) (~week 12), 3-Month Follow-Up (~week 24). Also Sessions 2, 4, 6, 8 of each therapy (corresponding to ~weeks 1, 2, 3, 4, 7, 8, 9, 10).

• Positive Valence Systems Scale (PVSS)

  Pre Tx (week 0), Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6), Post Tx-2 (after Exposure Therapy) (~week 12), 3-Month Follow-Up (~week 24). Also Sessions 2, 4, 6, 8 of each therapy (corresponding to ~weeks 1, 2, 3, 4, 7, 8, 9, 10).

• Positive and Negative Affect Schedule (PANAS)

  Pre Tx (week 0), Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6), Post Tx-2 (after Exposure Therapy) (~week 12), 3-Month Follow-Up (~week 24).

Study Arms (2)

Positive Affect Treatment - Behavioral (PAT-B)

EXPERIMENTAL

Focused on improving reward processing and anhedonia using PAT-B. Expected to reduce negative affect and increase positive affect. Then, exposure therapy to reduce public speaking anxiety.

Behavioral: Positive Affect Treatment - Behavioral (PAT-B); Behavioral: Exposure Therapy

Relaxation Treatment

ACTIVE COMPARATOR

Focused on relaxation and mindfulness using Relaxation Treatment. Expected to reduce negative affect. Then, exposure therapy to reduce public speaking anxiety.

Behavioral: Relaxation Treatment; Behavioral: Exposure Therapy

Interventions

Positive Affect Treatment - Behavioral (PAT-B) BEHAVIORAL

8 therapy sessions conducted individually with a therapist. Focuses on improving reward processing to increase positive emotional experience. Specific techniques include psychoeducation on mood cycle and positive emotions, mood monitoring, behavioral activation, and imaginal recounting and savoring of behavioral activation events. Intervention includes between-session practice.

Positive Affect Treatment - Behavioral (PAT-B)

Relaxation Treatment BEHAVIORAL

8 therapy sessions conducted individually with a therapist. Focuses on mindfulness and relaxation skills. Specific techniques include mindfulness approaches from dialectical behavior therapy, diaphragmatic breathing, and progressive muscle relaxation. Intervention includes between-session practice.

Relaxation Treatment

Exposure Therapy BEHAVIORAL

8 therapy sessions conducted individually with a therapist using the inhibitory retrieval model of exposure therapy. Sessions are designed to include four exposures each (32 exposures total). Each exposure is a public speech delivered to an audience. Goal of this treatment is to reduce public speaking anxiety. Principles of exposure therapy that will be incorporated are maximizing prediction error, maintaining attention to the situation/stimuli that are perceived predictors of the feared outcome (e.g., social rejection), removing safety signals, variability, engaging in post-exposure rehearsal/consolidation, deepened extinction, and positive occasion setter extinction. Intervention does not include between-session practice.

Positive Affect Treatment - Behavioral (PAT-B); Relaxation Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of social anxiety disorder from the Structural Clinical Interview for DSM 5.
• Elevated fear of public speaking, defined as a score of \>= 66 (+1SD from the mean of population norms on a scale of 17-85) on the Public Speaking Anxiety Scale (PSAS; Bartholomay, E. M., \& Houlihan, D. D. (2016). Public Speaking Anxiety Scale: Preliminary psychometric data and scale validation. Personality and individual differences, 94, 211-215), which is a self-report scale measuring anxiety of public speaking.
• Low reward processing, defined as a score of \<56 (less than the population mean) on the Dimensional Anhedonia Rating Scale (DARS) (Rizvi, S. J., Quilty, L. C., Sproule, B. A., Cyriac, A., Bagby, R. M., \& Kennedy, S. H. (2015). Dimensional Anhedonia Rating Scale (DARS) \[Database record\]. APA PsycTests).
• Medication-free or stabilized on psychotropic medications for a minimum standard length of time (1 month for benzodiazepines and beta blockers, 3 months for SRIs/SNRIs and heterocyclics).
• Psychotherapy-free or stabilized on alternative psychotherapies other than cognitive or behavioral therapies that were not focused on their anxiety disorder for at least 6 months prior to study entry.
• Age 18-60.
• Fluent in English.
• To conduct MRI version of fear conditioning task, must have no MRI contraindications.

You may not qualify if:

• Recent suicidal ideation with intent or plan - defined as suicidal ideation with intent or plan in the past year.
• Lifetime history of suicide attempts.
• History of bipolar disorder, psychosis, intellectual disability, or organic brain damage.
• Substance use disorder within the last 6 months.
• Major respiratory, cardiovascular, pulmonary, neurological, or muscular-skeletal diseases.
• Pregnant or planning to become pregnant for next 6 months.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90024, United States

RECRUITING

University of California, Los Angeles

Los Angeles, California, 90024, United States

RECRUITING

Related Links

• NIMH K23 grant

MeSH Terms

Conditions

Phobia, Social; Anhedonia; Anxiety Disorders; Phobic Disorders

Interventions

Implosive Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tomislav D Zbozinek, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Michelle G Craske, PhD

  University of California, Los Angeles

  STUDY CHAIR

Central Study Contacts

Tomislav D Zbozinek, PhD

CONTACT

6027502348; tzbozinek@ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Project Scientist

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: January 15, 2025
• Study Start: September 26, 2024
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available on NDA per their requirements, starting January, 2025, and will remain there per NDA policy. Supporting Information will be available approximately around the time of completion of the clinical trial and be made available indefinitely.
• Access Criteria: Access will be granted per NDA policy.

Locations

US (2)