Reward Processing and Exposure Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Exposure Therapy
- Conditions
- Not specified
- Sponsor
- University of California, Los Angeles
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Public Speaking Anxiety Scale (PSAS)
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
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.
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.
Investigators
Tomislav Zbozinek, PhD
Assistant Project Scientist
University of California, Los Angeles
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of social anxiety disorder from the Structural Clinical Interview for DSM
- •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.
- •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.
Arms & Interventions
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.
Intervention: Exposure Therapy
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.
Intervention: Positive Affect Treatment - Behavioral (PAT-B)
Relaxation Treatment
Focused on relaxation and mindfulness using Relaxation Treatment. Expected to reduce negative affect. Then, exposure therapy to reduce public speaking anxiety.
Intervention: Relaxation Treatment
Relaxation Treatment
Focused on relaxation and mindfulness using Relaxation Treatment. Expected to reduce negative affect. Then, exposure therapy to reduce public speaking anxiety.
Intervention: Exposure Therapy
Outcomes
Primary Outcomes
Public Speaking Anxiety Scale (PSAS)
Time Frame: 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).
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.
Behavioral Approach Task - Anxiety
Time Frame: 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).
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.
Behavioral Approach Task - Likelihood Expectancy
Time Frame: 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).
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.
Behavioral Approach Task - Skin Conductance
Time Frame: 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).
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.
Behavioral Approach Task - Electrocardiography RMSSD HRV
Time Frame: 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).
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.
Behavioral Approach Task - Severity Expectancy
Time Frame: 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).
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.
Behavioral Approach Task - Like/Dislike of Speech
Time Frame: 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).
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.
Behavioral Approach Task - Electrocardiography HF-HRV
Time Frame: 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).
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.
Behavioral Approach Task - Electrocardiography LF/HF-HRV
Time Frame: 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).
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.
Behavioral Approach Task - Speech Duration
Time Frame: 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).
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.
Secondary Outcomes
- 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).)
- 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).)
- 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 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).)
- Fear Conditioning - fMRI BOLD during shock omission(Pre Tx (week 0) and Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6).)
- Exposure Therapy - Perceived Historical Likelihood of Feared Outcome(Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).)
- Fear Conditioning - fMRI BOLD during conditional stimuli(Pre Tx (week 0) and Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6).)
- Exposure Therapy - Exposure Severity Expectancy(Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).)
- Exposure Therapy - Exposure Relief-Pleasantness(Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).)
- Exposure Therapy - EMA Likelihood Expectancy(Questionnaires are sent after each exposure therapy session: 2 hours after session, 24 hours after, and 48 hours after.)
- Exposure Therapy - EMA Valence(Questionnaires are sent after each exposure therapy session: 2 hours after session, 24 hours after, and 48 hours after.)
- Fear Conditioning - Relief-Pleasantness(Pre Tx (week 0) and Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6).)
- Exposure Therapy - Perceived Historical Severity of Feared Outcome(Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).)
- Exposure Therapy - Public Speaking Valence(Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).)
- Exposure Therapy - Exposure Likelihood Expectancy(Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).)
- Exposure Therapy - EMA Fear/Anxiety(Questionnaires are sent after each exposure therapy session: 2 hours after session, 24 hours after, and 48 hours after.)
- Exposure Therapy - EMA Relief-Pleasantness(Questionnaires are sent after each exposure therapy session: 2 hours after session, 24 hours after, and 48 hours after.)
- Fear Conditioning - Severity Expectancy(Pre Tx (week 0) and Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6).)
- Exposure Therapy - Exposure Fear/Anxiety(Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).)
- Exposure Therapy - Mood(Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).)
- Fear Conditioning - Skin Conductance(Pre Tx (week 0) and Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6).)
- Positive Affect Treatment - Behavioral and Relaxation Treatment: Mood(Sessions 1-8 of Positive Affect Treatment - Behavioral or Relaxation Treatment (corresponding to ~weeks 1-4).)
- Exposure Therapy - EMA Severity Expectancy(Questionnaires are sent after each exposure therapy session: 2 hours after session, 24 hours after, and 48 hours after.)
- Fear Conditioning - Likelihood Expectancy(Pre Tx (week 0) and Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6).)
- Fear Conditioning - Fear(Pre Tx (week 0) and Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6).)