Interoceptive Training Enhanced Mindfulness

Официальное название

Interoceptive Training Enhanced Mindfulness (ITEM): Acceptability and Measurement

Обзор

This pilot randomized controlled trial will compare a novel mindfulness training to interoceptive exposure to establish feasibility and acceptability as an intervention for anxiety sensitivity.

Подробное описание

Anxiety sensitivity (AS), which involves fear that arousal related symptoms will have negative physical, social or psychological ramifications, is an important driver of anxiety, trauma-related and somatic disorders. Cognitive behavioral therapy (CBT), particularly involving interoceptive exposure (IE; i.e., exposure to unwanted internal sensations), has the greatest demonstrated efficacy at reducing AS but can be hard to tolerate. Conversely, mindfulness is sought out for management of multiple mental health problems, but the observed clinical effects are often modest. A hybrid of these two approaches may capitalize on the strengths of each approach. Mindfulness training (MT) may increase the tolerability of exposure, enhance compliance and support extinction learning through increased engagement with the feared stimulus and heightened awareness of the nonoccurrence of feared outcomes. This project will evaluate the feasibility and acceptability of a novel hybrid intervention, Interoceptive Training Enhanced Mindfulness (ITEM), which combines IE with MT, evaluate its feasibility and acceptability. Forty-eight Veterans will be randomized to receive ITEM or IE in six one-on-one sessions delivered via telehealth. They will complete assessments before and after the 6-week intervention period. Outcomes related to engagement and compliance with ITEM and IE will be the primary focus. Because multiple mental health (e.g., anxiety, posttraumatic stress disorder, eating disorders and depression) and physical health (e.g., chronic pain, conditions related to toxic exposure) problems are driven by maladaptive reactions to interoceptive cues, this intervention has the potential to ultimately produce wide-spread mental and physical health benefits.

Вмешательства

• Другое Mindfulness training
  Brief mindfulness training focused on management of unwanted internal sensations
• Поведенческое Interoceptive exposure
  Cognitive behavioral therapy focused in interoceptive exposure to unwanted internal sensations

Первичные конечные точки

• Enrollment rate [Срок оценки: Typically up to 3 months, from initial referral to decision to enroll or not]
• Attendance [Срок оценки: During the six-week intervention period]
• Clinician's judgment of proportion of completion of at home assignments [Срок оценки: During the six-week intervention period]
• Client Satisfaction Questionnaire-4 (CSQ-4) [Срок оценки: Week 6, following the final treatment session]
• Reliable change [Срок оценки: Over a 6-8 week period from baseline to post-treatment]

Критерии участия

Критерии включения

• Veteran status
• able to read and speak English
• ASI-3 score of 23 or higher
• clinically meaningful distress/impairment related to an emotional or somatic complaint as determined by a Clinical Global Impression Scale (CGI) of 3 or greater
• Internet access via a device that can support remote study activities and ability to attend in person appointments

Критерии исключения

• serious mental illness, including bipolar disorder or psychotic illness
• current, untreated alcohol or substance use disorder
• moderate-severe suicidality that would likely result in the need for urgent intervention in the next 2 months
• current regular meditation practice or treatment for AS-related condition
• cognitive dysfunction that interferes with the ability to engage in treatment

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

Другое

Центры проведения

США · 1 центр

• VA San Diego Healthcare System — San Diego

Идентификаторы

NCT: NCT06786572 · H230149 · 1R34AT012499-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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