ACT for Veterans With IBD and Mental Health Challenges
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.
- Кому может быть актуально
- Состояния в реестре: Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis, Depressive Disorder. 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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Официальное название
Using Acceptance and Commitment Training to Promote Rehabilitation and Engagement in Values-Centered Living in Veterans Adapting to Inflammatory Bowel Disease and Mental Health Challenges (RECLAIM)
Обзор
Many Veterans with gastrointestinal disorders, such as inflammatory bowel disease (IBD), also have mental health conditions. IBD and mental health conditions can worsen one another through the brain-gut axis, leading to dramatic deficits in psychosocial functioning and quality of life (QOL). Yet, few Veterans with comorbid IBD and mental health conditions receive psychotherapy and no evidence-based psychotherapies have been tested in Veterans with these comorbidities. Adapting brief acceptance and commitment therapy (ACT) to the specific to the needs of these patients and embedding treatment into routine gastroenterology care may increase Veterans' access to efficient and effective rehabilitative care. This study aims to adapt and test an integrated, 1-Day ACT intervention tailored to the specific needs of Veterans with IBD and mental health conditions to improve psychosocial functioning and QOL.
Подробное описание
Nearly 80,000 Veterans have inflammatory bowel disease (Crohn's disease and ulcerative colitis; IBD). IBD is characterized by chronic inflammation of the gastrointestinal tract leading to significant pain, elimination difficulties, and functional impairment. Compounding these difficulties, nearly 50% of Veterans with IBD have comorbid depression, anxiety, and/or posttraumatic stress disorder. These comorbid conditions worsen IBD symptoms through the brain-gut axis, and lead to dramatic deficits in quality of life (QOL) and psychosocial functioning. Yet, less than 20% of patients with IBD and mental health conditions receive psychotherapy and 25-50% of psychotherapy patients drop out before clinically indicated. VA's integrated behavioral healthcare in primary and specialty care clinics increases therapy engagement and adherence, improving Veteran health and functioning. Despite this, psychogastroenterology services are underdeveloped in VA gastroenterology (GI) clinics. Moreover, no evidence-based psychotherapies have been tested in Veterans with comorbid IBD and mental health problems. It is essential to develop evidence-based psychotherapies for integrated use in GI clinics to practically increase access to care and improve the functioning and QOL of Veterans with GI conditions. Acceptance and commitment therapy (ACT) is a transdiagnostic psychotherapy that improves psychosocial functioning and QOL in patients with a variety of chronic and mental health conditions. ACT is flexibly delivered in various treatment formats, allowing providers to utilize methods that match the needs of specific populations and clinical settings. One-day ACT workshops improve access and retention while effectively and efficiently improving the psychosocial functioning of Veterans with various chronic health conditions. A pilot study of 1-day ACT for patients with IBD suggested preliminary feasibility, acceptability, and effectiveness in improving QOL. However, this pilot did not target Veterans or those with mental health conditions and was not delivered as an integrated part of GI care. This is a concern, as 1-day ACT is efficient and effective, yet is rarely used in routine clinical practice. Adapting 1-day ACT for integrated use in VA GI clinics will increase Veteran access to brief, evidence-based, rehabilitative treatment. This study aims to improve the psychosocial functioning and QOL of Veterans with comorbid IBD and mental health conditions by adapting and testing a 1-day, integrated ACT intervention, coined RECLAIM. The aims of this study are to: 1) Characterize the ACT-specific coping factors associated with psychosocial functioning and QOL in Veterans with IBD using survey and interview data to inform intervention adaptation; 2) Adapt a 1-day ACT intervention for Veterans with IBD and comorbid depressive, anxiety, and trauma disorders for integrated use in GI clinics. Pilot intervention (RECLAIM) with 10 Veterans and refine; 3) Test the feasibility and acceptability of RECLAIM with 40 Veterans with IBD and comorbid depressive, anxiety, and trauma disorders using a convergent mixed-methods design.
Вмешательства
- Поведенческое Acceptance and Commitment Therapy
Form of cognitive behavioral therapy that focuses on increasing psychological flexibility by fostering acceptance of difficult internal experiences, augmenting engagement in values-aligned behaviors, increasing contact with the present moment, and reducing reliance on avoidant coping.
Первичные конечные точки
- Feasibility of Intervention Measure (FIM) [Срок оценки: 2 week follow up]
- Therapist Fidelity to Treatment [Срок оценки: Immediate post-therapy assessment]
- Recruitment and Attrition Rates [Срок оценки: Screening, baseline, Immediate post-therapy assessment, 2 week follow up, 3 month follow up, 6 month follow up]
- Single item assessing participant engagement in treatment as rated by therapist [Срок оценки: Immediate post-therapy assessment]
- Percentage of treatment a patient completed [Срок оценки: Immediate post-therapy assessment]
- Acceptability of Intervention Measure (AIM) [Срок оценки: 2 week follow up]
- Intervention Appropriateness Measure (IAM) [Срок оценки: 2 week follow up]
- Inflammatory Bowel Disease Questionnaire (IBDQ) [Срок оценки: 3 month follow up]
- PROMIS-SF Social Functioning Scales [Срок оценки: 3 month follow up]
- PROMIS-SF Psychosocial Illness Impact [Срок оценки: 3 month follow up]
Вторичные конечные точки (7)
- Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: 3 month follow up]
- Patient Health Questionnaire- 9 (PHQ-9) [Срок оценки: 3 month follow up]
- PTSD Checklist for DSM-5 (PCL-5) [Срок оценки: 3 month follow up]
- Visceral Sensitivity Index (VSI) [Срок оценки: 3 month follow up]
- Patient Reported Outcomes 2 and 3 (PRO2, PRO3) [Срок оценки: 3 month follow up]
- The Brief Pain Inventory-Short Form (BPI-SF) [Срок оценки: 3 month follow up]
- Acceptance and Action Questionnaire-II (AAQ-II) [Срок оценки: 3 month follow up]
Критерии участия
Критерии включения
- Diagnosis of IBD as confirmed by the medical record
- Current diagnosis of a depressive, anxiety, or trauma-related disorder
Критерии исключения
- Severe IBD symptoms that would prevent full participation in the study (i.e., hospitalized in the past 30 days, surgery in the past 30 days)
- Significant cognitive impairment
- Active suicidality
- Uncontrolled psychosis or bipolar disorder
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston
Идентификаторы
NCT: NCT07397195 · RRD9-007-25M · 1IK2RD000689-01A2