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Идёт набор NCT06162624

Pilot Effectiveness Trial of an ACT Self-help Workbook Tailored Specifically for Prisons

Без фазы С лечением Anxiety Depression Depression, Anxiety Anxiety Disorders

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: Acceptance and Commitment Therapy (ACT), Reflective Journaling.
Кому может быть актуально
Состояния в реестре: Anxiety, Depression, Depression, Anxiety, Anxiety Disorders. 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 →

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Обзор

The goal of this research study is to adapt an ACT-self-help workbook to the prison setting and determine the feasibility acceptability, and effectiveness of this workbook. Participants can expect to be in the study for 13 weeks.

Подробное описание

The Specific Aims of the proposed study correspond directly to the three-step process.

1. In Step 1 (Specific Aim #1), identify the necessary adaptations to the content, language, and format of an ACT-based self-help workbook through stakeholder input. 2. In Step 2 (Specific Aim #2), refine the workbook and its delivery based on feedback from incarcerated individuals who complete the workbook. 3. In Step 3 (Specific Aim #3), determine the feasibility, acceptability and preliminary effectiveness of the ACT self-help workbook in a prison setting. Primary clinical outcome measure will be depression, secondary clinical outcome measure will be anxiety.

For each participant assigned to a condition, a study team member will meet with them individually to provide them with a copy of the workbook. During this meeting, the study team member will inform the participant that they should complete one chapter per week.

Participants will complete a Pre-Treatment Assessment prior to distribution of the workbook; a Mid-Treatment Assessment four weeks after the distribution of the workbook; a Post-Treatment Assessment #1 eight weeks after distribution of the workbook (when the workbook should be completed); Focus group (after completion of workbook) and, a Post-Treatment Assessment #2 twelve weeks after distribution of the workbook.

Вмешательства

  • Поведенческое Acceptance and Commitment Therapy (ACT)
    ACT: Therapy that builds in traditional cognitive behavioral therapy principles but emphasizes different processes in behavior change. Delivered over 8 weeks of self-guided study and homework assignments.
  • Поведенческое Reflective Journaling
    As control condition, reflective journaling will be used.

Первичные конечные точки

  • Eligible participants [Срок оценки: Study duration, up to 1 year]
  • Participants who choose to participate [Срок оценки: Study duration, up to 1 year]
  • Percentage of participants that complete all 8 weeks [Срок оценки: Study duration, up to 1 year]
  • Qualitative Summary of Reasons for Attrition [Срок оценки: Study duration, up to 1 year]
  • Number of Participants referred for Follow up care [Срок оценки: Up to 13 weeks]
  • Participant Satisfaction [Срок оценки: Up to 13 weeks]
  • Change in Mental Health: Flexibility [Срок оценки: Baseline to 13 weeks]
  • Change in Mental Health: Automatic Thoughts [Срок оценки: Baseline to 13 weeks]
  • Change in BAI Score [Срок оценки: Baseline to 13 weeks]
  • Change BDI-II Score [Срок оценки: Baseline to 13 weeks]

Критерии участия

Критерии включения

  • 18 years of age or older
  • Reading level of 6th grade or higher determined by the Wide Range Achievement Test
  • Moderate or severe anxiety and/or depression determined by the Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI)
  • No active self-harm or active suicidal intent
  • No scheduled transfer or release for at least three months
  • Must be willing and able to participate, including having permission and ability to use study materials, such as paper and a writing utensil

Критерии исключения

  • Unable to provide informed consent
  • Active self-harm or suicidal intent
  • Scheduled transfer or release within three 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 · 1 центр
  • University of Wisconsin — Madison

Идентификаторы

NCT: NCT06162624 · 2023-1590 · 1R34MH132663-01A1 · Protocol Version 4/13/26 · A538900 · SMPH/PSYCHIATRY/PSYCHIATRY

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗