Reward Processing and Exposure Therapy for Social Anxiety Disorder

Официальное название

Reward Processing and Exposure Therapy

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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

Первичные конечные точки

• Public Speaking Anxiety Scale (PSAS) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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).]

Вторичные конечные точки (12)

• Liebowitz Social Anxiety Scale (LSAS) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Pre Tx (week 0) and Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6).]
• Fear Conditioning - fMRI BOLD during conditional stimuli [Срок оценки: Pre Tx (week 0) and Post Tx-1 (after PAT-B or Relaxation Treatment) (~week 6).]
• Exposure Therapy - Perceived Historical Likelihood of Feared Outcome [Срок оценки: Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).]
• Exposure Therapy - Perceived Historical Severity of Feared Outcome [Срок оценки: Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).]
• Exposure Therapy - Public Speaking Valence [Срок оценки: Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).]
• Exposure Therapy - Exposure Likelihood Expectancy [Срок оценки: Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).]
• Exposure Therapy - Exposure Severity Expectancy [Срок оценки: Sessions 1-8 of Exposure Therapy (corresponding to ~weeks 7-10).]

Критерии участия

Критерии включения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• University of California, Los Angeles — Los Angeles
• University of California, Los Angeles — Los Angeles

Идентификаторы

NCT: NCT06776991 · 1K23MH133971-01A1 · 1K23MH133971-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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