Идёт набор NCT06207318

Acceptance and Commitment Therapy for Patients Undergoing Coronary Artery Bypass Graft Surgery

Без фазы С лечением Coronary Artery Disease Vascularization

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: Coronary Artery Disease, Vascularization. Базовые параметры: 18 лет — 80 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

Acceptance and Commitment Therapy for the Perioperative Period of Coronary Artery Bypass Graft Surgery: a Randomized Controlled Feasibility Trial

Обзор

Heart disease is the leading cause of death globally, accounting for 16% of the world's total deaths. The number of cases is expected to increase as our population ages. Heart disease also results in large economic burden. It costs the United States about $219 billion per year. Some patients have symptoms that aren't helped by drugs or other medical treatments. These patients will need a surgery that is called cardiac artery bypass graft (CABG) surgery. CABG helps to improve chest pain which is one of the most common complaints of heart disease, and has life-prolonging potential. A limitation of CABG is that it results in increased inflammation. These patients also report high levels of anxiety and depression. Depression and anxiety in the several days surrounding surgery are related to several important things. These include worse health outcomes, worse quality of life, increased risk of death, and increased health care cost. Acceptance and Commitment Therapy (ACT) is a kind of therapy. ACT is adaptable, easy to access, and effective in brief formats. ACT has been gaining evidence for its use in many patient samples. Few studies have used ACT with heart disease patients. No known studies currently exist that have used ACT within the few days surrounding CABG surgery. To address this need, the investigators will conduct a two-arm feasibility randomized control trial (RCT). Patients will be randomized to one of two groups. The first group will complete a brief, 2-session telehealth ACT intervention. The second group will be a control group. The control will consist of treatment as usual. The investigators will evaluate the feasibility of this brief ACT intervention delivered in the peri-operative period. The investigators will also examine preliminary efficacy of the ACT intervention. The investigators will examine anxiety, depression, psychological inflexibility, well-being, and cardiovascular health-related quality of life. The investigators will also examine the intervention's impact on inflammation by measuring two inflammatory markers. The results from this study will also lay the groundwork for larger or multiple site RCT studies.

Вмешательства

Поведенческое Acceptance and commitment therapy
The intervention will be based on Acceptance and Commitment Therapy (ACT). ACT is an empirically-based therapeutic approach that focuses on psychological flexibility, acceptance, and the reduction of experiential avoidance. It encourages individuals to change their relating to thoughts and experiences and act in accordance with their values.

Первичные конечные точки

Theoretical Framework of Acceptability (TFA) questionnaire [Срок оценки: 8 weeks]
Participant Satisfaction measure [Срок оценки: 8 weeks]
Participant Adherence measure [Срок оценки: 8 weeks]
Participant Enrollment [Срок оценки: Baseline]
Intervention Delivery [Срок оценки: 8 weeks]
Completion of Study Procedures [Срок оценки: 8 weeks]
Retention [Срок оценки: 8 weeks]

Вторичные конечные точки (7)

Patient Health Questionnaire (PHQ-9) [Срок оценки: 8 weeks]
Generalized Anxiety Disorder Questionnaire (GAD-7) [Срок оценки: Baseline and 8 weeks]
Mental Health Continuum-Short Form (MHC-SF) [Срок оценки: Baseline and 8 weeks]
MacNew Heart Disease Health Related Quality of Life (HRQoL) [Срок оценки: Baseline and 8 weeks]
Comprehensive Assessment of Acceptance Commitment Therapy Processes (CompACT)-15 [Срок оценки: Baseline and 8 weeks]
interleukin 6 (IL-6) [Срок оценки: Baseline and 8 weeks]
high sensitivity c-reactive protein (hs-CRP) [Срок оценки: Baseline and 8 weeks]

Критерии участия

Критерии включения

admission to the Heart and Vascular Center at University of Iowa Hospitals and Clinics (UIHC) for urgent or elective CABG
access to a personal phone or device with video or audio capabilities
ability to provide informed consent
English fluency.