Reward Processing and Exposure Therapy for Social Anxiety Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: Positive Affect Treatment - Behavioral (PAT-B)Experimental treatment 2 interventions
Group B: Relaxation TreatmentActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

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).
2

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.

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).
3

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.

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).
4

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.

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).

Secondary outcomes

1

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.

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).
2

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.

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).
3

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.

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).
4

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.

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).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator