Reward Processing and Exposure Therapy for Social Anxiety Disorder (METER)

Reward Processing and Exposure Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Anhedonia; Phobic Disorders; Social Anxiety Disorder (Social Phobia); ANXIETY DISORDERS (or Anxiety and Phobic Neuroses); Public Speaking Anxiety
• Intervention / Treatment: Behavioral: Positive Affect Treatment - Behavioral (PAT-B); Behavioral: Exposure Therapy; Behavioral: Relaxation Treatment

Detailed Description

A substantial number of individuals do not achieve clinically significant symptom relief from exposure therapy, or they may experience return of fear following completion of exposure therapy. This clinical trial aims to intervene on one potential reason exposure therapy's success is mitigated: anhedonia. Anhedonia is characterized by physiological, behavioral, neural, and self-report deficits in reward processing - where reward processing includes anticipation of reward (positive experiences, such as social connection, food, personal achievement), engaging in effort for reward, feeling motivated for reward, savoring reward when it occurs, taking responsibility for the occurrence of reward, and learning what leads to reward. In basic scientific studies of non-humans and humans, poor reward processing is associated with poor extinction of fear (i.e., poor reduction of fear), and anxiety disorders (e.g., social anxiety disorder) often have elevated anhedonia. Therefore, individuals who are both anxious and anhedonic likely experience deficits in extinguishing fear, which is a core process of exposure therapy. Methods of improving reward processing and anhedonia may thus increase the efficacy of exposure therapy.

The present clinical trial will recruit individuals who are clinically socially anxious, have elevated public speaking anxiety, and have anhedonia / poor reward processing. Participants will all do Exposure Therapy for public speaking anxiety, but before doing so, they will be randomized to one of two treatment conditions: the behavioral portion of Positive Affect Treatment (PAT-B; to increase reward processing and reduce anhedonia), and Relaxation Treatment (comprised of mindfulness, diaphragmatic breathing, and progressive muscle relaxation). Assessments including a public speech behavioral approach task, questionnaires, and fear conditioning. The behavioral approach task and questionnaires will be conducted before participants' first treatment (Pre Tx; before PAT-B or Relaxation Treatment), after their first treatment (Post Tx-1), after Exposure Therapy (Post Tx-2), and three months after completing Exposure Therapy (3-Month Follow-Up). The fear conditioning task will be conducted before participants' first treatment (Pre Tx; before PAT-B or Relaxation Treatment) and after their first treatment (Post Tx-1); this will be done either in an fMRI or non-fMRI setting, depending on whether participant has MRI contraindications or based on study needs.

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tomislav D Zbozinek, PhD; Phone Number: 6027502348; Email: tzbozinek@ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • Recruiting
      • University of California, Los Angeles
      • Contact: Tomislav D Zbozinek, PhD; Phone Number: 310-206-9191; Email: tzbozinek@ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria (none of the following):

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive Affect Treatment - Behavioral (PAT-B); 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); 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.; Behavioral: Exposure Therapy; 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.
Active Comparator: Relaxation Treatment; Focused on relaxation and mindfulness using Relaxation Treatment. Expected to reduce negative affect. Then, exposure therapy to reduce public speaking anxiety.	Behavioral: Exposure Therapy; 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.; Behavioral: Relaxation Treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liebowitz Social Anxiety Scale (LSAS)	Self-report measure of social anxiety. This measure is a 48-item questionnaire in which participants respond to how much fear or anxiety (0-3 scale, where = 0 none, 1 = mild, 2 = moderate, and 3 = severe) and how much they avoid (0-3, where 0 = never (0%), 1 = occasionally (1-33%), 2 = often (33-67%), and 3 = usually (67-100%) 24 social situations. Scores range 0-144. 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).
Dimensional Anhedonia Rating Scale (DARS)	Self-report measure of anhedonia / reward processing. This is a questionnaire consisting of 17 items on a 0-4 scale (0 = not at all, 2 = moderately, 4 = very much) asking participants to name several positive activities and then to what degree they would have positive thoughts or emotions regarding those activities (e.g., how much they want to do those activities). Scores range 0-68. 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).
Depression, Anxiety, and Stress Scale (DASS-21)	Self-report measures of depression, anxiety, and stress. Scale consists of 21 items (7 depression, 7 anxiety, and 7 stress) rated on a 0-3 scale (0 = did not apply to me at all, 1 = applied to me at some degree or some of the time, 2 = applied to me to a considerable degree or a good part of time, and 3 = applied to me very much or most of the time). Total scores range 0-63; depression, anxiety, and stress subscale scores range 0-21 each. 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).
Positive Valence Systems Scale (PVSS)	Self-report measure of anhedonia / reward processing. This is a questionnaire consisting of 21 items on a 1-9 scale (1 = extremely untrue of me, 5 = neutral, 9 = extremely true of me) with statements related to NIMH's positive valence systems (e.g., anticipation of reward, response to reward attainment). Mean scores range 1-9. 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). 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)	Self-report measure of positive and negative affect. This is a questionnaire consisting of 20 items on a 1-5 scale (1 = very slightly or not at all, 3 = moderately, 5 = extremely). Each item is a positive or negative emotion, and participants rate how much they experienced that emotion. Two subscales are scored: positive affect and negative affect. Each subscale's score ranges 10-50. For the positive affect subscale, higher = better. For the negative affect subscale, 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).
Fear Conditioning - fMRI BOLD during shock omission	Neural responses (i.e., BOLD) measurement during shock omission in extinction phase. BOLD responses during this stimulus will be contrasted to BOLD responses during inter-trial intervals (ITIs), with a focus on reward neurocircuitry (e.g., striatum). For BOLD values in the reward circuitry, higher = better.	Pre Tx (week 0) and Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6).
Fear Conditioning - fMRI BOLD during conditional stimuli	Neural responses (i.e., BOLD) measurement during acquisition and extinction phases to each conditional stimulus. BOLD responses during these stimuli will be contrasted to BOLD responses during inter-trial intervals (ITIs), with a focus on neurocircuitry involved in threat processing (e.g., amygdala) and inhibition (e.g., ventromedial prefrontal cortex). For BOLD values in the threat circuitry, higher = worse. For BOLD values in the inhibitory circuitry, higher = better.	Pre Tx (week 0) and Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6).
Exposure Therapy - Perceived Historical Likelihood of Feared Outcome	Self-report questionnaire item asking participants across all of the public speeches they have ever given, how often does it feel like their feared outcome (e.g., social rejection) has occurred. Scale ranges 0-100 (0 = 0% of the time, 100 = 100% of the time). Higher = worse.	Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).
Exposure Therapy - Perceived Historical Severity of Feared Outcome	Self-report questionnaire item asking participants across all of the public speeches they have ever given, when their feared outcome has occurred (e.g., social rejection) how severe does it feel like it has been. Scale ranges 0-100 (0 = not at all, 50 = moderate, 100 = extreme). Higher = worse.	Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).
Exposure Therapy - Public Speaking Valence	Self-report questionnaire item asking participants how much they like or dislike giving public speeches. Scale ranges -10 to +10 (-10 = dislike very much, 0 = neutral, +10 = like very much). Higher = better.	Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).
Exposure Therapy - Exposure Likelihood Expectancy	Self-report questionnaire item asking participants how certain they are that their feared outcome will/did occur during a given exposure ranging 0-100 (0 = certain will/did not occur, 50 = completely uncertain, 100 = certain will/did occur). Higher = worse.	Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).
Exposure Therapy - Exposure Severity Expectancy	Self-report questionnaire item asking participants how severe they believe their feared outcome will be / was if it were to / did occur, ranging 0-100 (0 = not at all, 50 = moderate, 100 = extreme). Higher = worse.	Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).
Exposure Therapy - Exposure Fear/Anxiety	Self-report questionnaire item asking participants how their fear/anxiety level regarding a given exposure (0 = none, 50 = moderate, 100 = extreme). Higher = worse.	Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).
Exposure Therapy - Exposure Relief-Pleasantness	Self-report questionnaire item asking participants how relieved/pleasant they feel because their feared outcome (e.g., social rejection) did not occur or likely did not occur, ranging 0-100 (0 = not at all, 50 = moderately, 100 = extremely). Higher = better.	Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).
Exposure Therapy - Mood	Self-report questionnaire item asking participants their current mood, ranging -10 to +10 (-10 = extremely negative, = 0 neutral, +10 = extremely positive). Higher = better.	Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).
Positive Affect Treatment - Behavioral and Relaxation Treatment: Mood	Self-report questionnaire item asking participants their current mood, ranging -10 to +10 (-10 = extremely negative, = 0 neutral, +10 = extremely positive). Higher = better.	Sessions 1-8 of Positive Affect Treatment - Behavioral or Relaxation Treatment (corresponding to ~weeks 1-4).
Exposure Therapy - EMA Likelihood Expectancy	Questionnaire item measured with regards to most recently completed exposure via ecological momentary assessment (EMA). Participant rates how certain they are that, if participant were to repeat the most recent exposure from their previous Exposure Therapy session, how certain are they that their feared outcome (e.g., social rejection) would occur. Scores range 0-100 (0 = certain will not occur, 50 = completely uncertain, 100 = certain will occur). Higher = worse.	Questionnaires are sent after each exposure therapy session: 2 hours after session, 24 hours after, and 48 hours after.
Exposure Therapy - EMA Severity Expectancy	Questionnaire item measured with regards to most recently completed exposure via ecological momentary assessment (EMA). Participant rates, if they were to repeat the most recent exposure from their previous Exposure Therapy session and their feared outcome (e.g., social rejection) were to occur, how severe do they believe their feared outcome would be. Scores range 0-100 (0 = not at all, 50 = moderate, 100 = extreme). Higher = worse.	Questionnaires are sent after each exposure therapy session: 2 hours after session, 24 hours after, and 48 hours after.
Exposure Therapy - EMA Fear/Anxiety	Questionnaire item measured with regards to most recently completed exposure via ecological momentary assessment (EMA). Participant rates, if they were to repeat the most recent exposure from their previous Exposure Therapy session, how much fear/anxiety would they have. Scores range 0-100 (0 = none, 50 = moderate, 100 = extreme). Higher = worse.	Questionnaires are sent after each exposure therapy session: 2 hours after session, 24 hours after, and 48 hours after.
Exposure Therapy - EMA Relief-Pleasantness	Questionnaire item measured with regards to most recently completed exposure via ecological momentary assessment (EMA). Participant rates, if they were to repeat the most recent exposure from their previous Exposure Therapy session and their feared outcome (e.g., social rejection) were to not occur, how pleasant/relieved would they feel. Scores range 0-100 (0 = not at all, 50 = moderate, 100 = extreme). Higher = better.	Questionnaires are sent after each exposure therapy session: 2 hours after session, 24 hours after, and 48 hours after.
Exposure Therapy - EMA Valence	Questionnaire item asking how much participant likes or dislikes giving public speeches. Scores range -10 to +10 (-10 = dislike very much, 0 = neutral, +10 = like very much). Higher = better.	Questionnaires are sent after each exposure therapy session: 2 hours after session, 24 hours after, and 48 hours after.
Fear Conditioning - Likelihood Expectancy	During fear conditioning task, questionnaire item asking how certain the participant is that they will receive electric shock the next time they see each stimulus. Scores range 1-9 (1 = certain "no", 5 = completely uncertain, 9 = certain "yes"). Higher = worse.	Pre Tx (week 0) and Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6).
Fear Conditioning - Severity Expectancy	During fear conditioning task, questionnaire item asking how certain the participant is that the next time they see each stimulus, if they were to receive electric shock, how severe do they believe it will be. Scores range 1-9 (1 = not at all, 5 = moderate, 9 = extreme). Higher = worse.	Pre Tx (week 0) and Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6).
Fear Conditioning - Fear	During fear conditioning task, questionnaire item measured asking how fearful each stimulus makes them feel. Scores range 1-9 (1 = not at all, 5 = moderately, 9 = extremely). Higher = worse.	Pre Tx (week 0) and Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6).
Fear Conditioning - Relief-Pleasantness	During fear conditioning task in the extinction phase, questionnaire item measuring how pleasant/relieved the participant feels because this stimulus did not result in electric shock. Scores range 1-9 (1 = not at all, 5 = moderately, 9 = very). Higher = better.	Pre Tx (week 0) and Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6).
Fear Conditioning - Skin Conductance	During fear conditioning task, measure skin conductance (physiological) and calculate skin conductance response to each stimulus by subtracting the mean value 2sec prior to each stimulus from the maximum value 1-6sec after each stimulus's onset. Then, range correct the scores by dividing by the largest observed skin conductance value, and then normalizing the range-corrected scores by taking their square root. Scores range 0-1. Higher = worse.	Pre Tx (week 0) and Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6).

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Tomislav D Zbozinek, PhD, University of California, Los Angeles; Study Chair: Michelle G Craske, PhD, University of California, Los Angeles

Publications and helpful links

Helpful Links

• NIMH K23 grant

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2024
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; Social Anxiety; Reward Processing; Anhedonia; Exposure Therapy; Public Speaking Anxiety; Inhibitory Retrieval; Positive Affect Treatment; Relaxation Treatment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Phobia, Social; Anxiety Disorders; Anhedonia; Phobic Disorders; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Desensitization, Psychologic; Implosive Therapy
• Other Study ID Numbers: 1K23MH133971-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators plan to upload non-identifiable data to the National Institute of Mental Health's (NIMH) Data Archive (NDA) per their policy. This will include individual participant data.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Access will be granted per NDA policy.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No