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Идёт набор NCT07219875

Training Reward Responsiveness Through Virtual Reality

Фаза II С лечением Positive Affect Depression

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Virtual Reality-Reward Training (VR-RT), Virtual Reality-Memory Training (VR-MT).
Кому может быть актуально
Состояния в реестре: Positive Affect, Depression. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Virtual Reality Training Study

Обзор

The purpose of this study is to compare the effects of Virtual Reality-Reward Training (VR-RT) with an active control condition, Virtual Reality-Memory Training (VR-MT), on positive affect and other clinical symptoms. VR-Reward Training is a novel intervention aimed at enhancing savoring of positive experiences among individuals with depression and low positive affect through guided imaginal recounting following immersion in positive VR experiences. The current study tests an enhanced version of this training using improved virtual reality technology. Target enrollment is 80 participants with low positive affect, depression, and impaired functioning, who are at least 18 years old, who will be randomly assigned to 7 weeks of either Virtual Reality-Reward Training (VR-RT) or Virtual Reality-Memory Training (VR-MT). Participants will complete in-person VR sessions, laboratory assessments, self-report questionnaires as part of the study. A subset of 8 participants randomly assigned to VR-RT will complete fMRI scans and EMA surveys. The total length of participation is around 3 months.

Подробное описание

Anhedonia, or loss of interest and pleasure in usual activities, has been relatively resistant to pharmacological and psychological treatments in the context of anxiety and depression. Newer treatments that focus upon positivity or reward sensitivity have shown promising results.

The purpose of the current randomized controlled trial is to compare the effects of Virtual Reality-Reward Training (VR-RT) with an active control condition, Virtual Reality-Memory Training (VR-MT), on positive affect and other clinical symptoms. Virtual Reality-Reward Training is designed to augment reward sensitivity in individuals with depression and low positive affect. Targets include reward anticipation and initial response to reward. Specificity of target engagement is assessed by comparison with Virtual Reality-Memory Training, designed to improve memory.

Targets and clinical outcomes are assessed at Week 0 Assessment (Week 0) and either weekly or at mid-treatment (Week 7), post-treatment (1 week after Session 14), and follow-up (Week 12). Statistical models evaluate whether change in outcomes and change in target measures are greater as a result of Virtual Reality-Reward Training compared to Virtual-Reality-Memory Training and whether changes in target measures correlate with changes in outcome measures.

Target enrollment is 80 participants with low positive affect, depression, and impaired functioning, who are at least 18 years old, who will be randomized to Virtual Reality-Reward Training or Virtual-Reality Memory Training, each comprising 13 individual virtual reality training sessions over the course of 7 weeks.

Participants will complete laboratory tests and self-report questionnaires as part of the study. Total length of participation is around 3 months.

Вмешательства

  • Поведенческое Virtual Reality-Reward Training (VR-RT)
    Participants will complete verbal recounting (present-tense, field perspective, positive details) and guided imaginal recounting of positive details for rewarding VR experiences and positive autobiographical memories.
  • Поведенческое Virtual Reality-Memory Training (VR-MT)
    Participants will complete verbal recounting (past-tense, observer perspective, objective details) and guided imaginal recounting of neutral details for neutral VR experiences and neutral non-personal stories

Первичные конечные точки

  • The Mood and Anxiety Symptoms Questionnaire - Anhedonic Depression Subscale (MASQ-AD) [Срок оценки: Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).]
  • Positive Valence Systems Scale (PVSS-21) [Срок оценки: Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).]
Вторичные конечные точки (12)
  • Depression, Anxiety, and Stress Scales (DASS-21) [Срок оценки: Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).]
  • Positive and Negative Affective Schedule (PANAS) [Срок оценки: Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).]
  • Positive and Negative Affective Schedule (PANAS-X) [Срок оценки: Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).]
  • Responses to Positive Affect Questionnaire (RPA) [Срок оценки: Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).]
  • Work and Social Adjustment Scale (WSAS) [Срок оценки: Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).]
  • igroup Presence Questionnaire (IPQ) [Срок оценки: Change from Week 0 assessment to Post-Assessment (Week 8).]
  • Memory Retrieval Task [Срок оценки: Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).]
  • Heart Rate Variability [Срок оценки: Change from VR Session 1 (Week 1) to VR Session 13 (Week 7).]
  • State Affect [Срок оценки: Change from VR Session 1 (Week 1) to VR Session 13 (Week 7).]
  • Change in reward-relevant neural activity [Срок оценки: Change from Week 0 Assessment to Post Assessment (Week 8)]
  • Blood-Based Biomarkers [Срок оценки: Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).]
  • Depressive Symptoms Composite Score [Срок оценки: Change from Week 0 assessment to Post-Assessment (Week 8). Change from Week 0 assessment to Follow-Up (Week 12).]

Критерии участия

Критерии включения

  • At least 18 years old
  • Fluent in written and spoken English
  • Meet all of the following dimensional score cutoffs:
  • Score on the DASS-21 depression subscale must be ≥ 8
  • Score on the PANAS-P of 27 or lower
  • Score on the WSAS of ≥ 11

Критерии исключения

  • Lifetime history of bipolar disorder, psychosis, mental retardation, or organic brain damage
  • Substance use disorder in the past 6 months
  • Current use of psychotropic medications
  • Currently pregnant or planning to become pregnant
  • Self-reported frequent motion sickness
  • Self-reported seizures within the last year and/or a diagnosis of epilepsy

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
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of California, Los Angeles — Los Angeles

Идентификаторы

NCT: NCT07219875 · IRB-22-0269

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗