Computer - Based Treatment for Social Anxiety Disorder

Официальное название

Computer-Based Treatment for Social Anxiety Disorder, A Randomized Controlled Trial

Обзор

The present study is a controlled trial that seeks to examine the feasibility, acceptability, mechanism, and efficacy of a recently developed computer-based therapy in individuals with social anxiety disorder (SAD)

Подробное описание

This randomized clinical trial examines the feasibility, acceptability, mechanism, and relative efficacy of two forms of a recently developed 4-week/8-session computer-based therapy in individuals with social anxiety disorder (SAD). The purpose of this study is to assess whether a brief computer-based research treatment, provided in 30 minutes sessions, helps improve social anxiety symptoms, and by what mechanism. The study will also assess the effect of research treatments on brain activity using magnetic resonance imaging (MRI).

Вмешательства

• Поведенческое Computer-Based Treatment
  A 4-week (8 30-minute sessions) course of computer-based treatment involving viewing pictures of faces while music may play. Participants will receive research treatment twice a week.

Первичные конечные точки

• Change in Total Score of Liebowitz Social Anxiety Scale (LSAS) [Срок оценки: From baseline up to Month 4]
• Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire [Срок оценки: From baseline up to Month 4]

Вторичные конечные точки (2)

• Change in Total Score of Social Phobia Inventory (SPIN) [Срок оценки: Baseline to Month 4]
• Clinical Global Impression-Change Scale [Срок оценки: Baseline to Month 4]

Критерии участия

Критерии включения

• Males and females between the ages of 18 to 60
• Current primary diagnosis of SAD
• Score of at least 50 on the Liebowitz Social Anxiety Scale (self-rated version)
• Fluent in English
• Willing and able to give informed written consent
• Ability to participate responsibly in the protocol
• Normal or corrected-to-normal vision

Критерии исключения

• Present or past psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder, or bipolar disorder
• Current severe depression
• Suicidal ideation or behavior
• Current diagnosis of post-traumatic stress disorder, obsessive-compulsive disorder, bipolar disorder, manic episode or tic disorder
• Current or past organic mental disorder, seizure disorder, epilepsy or brain injury
• Current unstable or untreated medical illness
• Severe alcohol use disorder, severe cannabis use disorder, and any severity of other substance use disorder (except nicotine use disorders)
• Use of psychiatric medication in the past month other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) for at least 3 months
• Any concurrent cognitive behavioral therapy or other psychotherapy that was initiated in the past 3 months
• Pregnancy, or plans to become pregnant during the period of the study (will be assessed by urine)
• Contraindication to MRI scanning (Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body)

• pacemaker
• paramagnetic metallic prosthesis
• surgical clips
• shrapnel
• necessity for constant medicinal patch
• some tattoos
• Inability to tolerate MRI scanning procedures (i.e., severe obesity, claustrophobia)

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

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• 1051 Riverside Drive — New York

Идентификаторы

NCT: NCT04663724 · 8072 · 5R33MH116089-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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