Evaluation of a Twenty-session Cognitive-behavioral Therapy With Anorexia Nervosa (CBT-20-AN) Among Adults (18+)

Официальное название

Twenty-session Cognitive-behavioral Therapy for Adults With Anorexia Nervosa (CBT-20-AN)

Обзор

The study is a clinical trial assessing the efficacy of a new twenty session cognitive behavioral therapy for adults (18+) with anorexia nervosa (AN) and atypical anorexia nervosa. It is expected that participants will gain a significant amount of weight and experience a significant decrease in eating disorder psychopathology and behavior from pre- to post- treatment and that this will be retained after 6-months.

Вмешательства

• Поведенческое Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN)
  Twenty session cognitive behavioral therapy for Anorexia Nervosa (CBT-20-AN) is an treatment for Anorexia Nervosa and Atypical Anorexia Nervosa delivered by a mental health clinician. This treatment (CBT-20-AN) lasts just 20 sessions and has been designed to allow individuals with AN to reap the benefits of CBT for eating disorders (up to 40 sessions) in less time, increasing access to care and shortening time to symptom reduction.

Первичные конечные точки

• Patient weight [Срок оценки: Change from study treatment week one to final session, an average of 25 weeks after week one (measured at weekly study treatment sessions), and to the one, three, and six-month follow-up session, up to 11 months after week one.]
• Generalized Anxiety Disorder (GAD-7) [Срок оценки: Change from week one of study treatment to post-treatment following final session, an average of 25 weeks after week one (measured at weeks one, six, and twenty), and to one, three, and six-month follow-up sessions, up to 11 months after week one.]
• Patient Health Questionnaire - 9 (PHQ-9) [Срок оценки: Change from week one of study treatment to post-treatment following final session, an average of 25 weeks after week one (measured at weeks one, six, and twenty), and to one, three, and six-month follow-up sessions, up to 11 months after week one.]
• Eating Disorder Examination Interview (EDE) [Срок оценки: Change from baseline assessed at screen visit to post-treatment following final session, an average of 25 weeks after baseline assessment.]
• Eating Disorder Examination Questionnaire (EDE-Q6) [Срок оценки: Change from week one of study treatment to post-treatment following final session, an average of 25 weeks after week one (measured at weeks one, six, and twenty), and to one, three, and six-month follow-up sessions, up to 11 months after week one.]
• Eating Disorder - 15 Scale (ED-15) [Срок оценки: Change from study treatment week one to post-treatment following final session, an average of 25 weeks after week one (measured at weekly study treatment session), and to the one, three, and six-month follow-up session, up to 11 months after week one.]
• Working Alliance Inventory Short (WAI-SR) [Срок оценки: Change from week one of study treatment to post-treatment following final session, an average of 25 weeks after week one (measured at weeks one, six, and twenty), and to the six-month follow-up session, up to 11 months after week one.]
• General Self-Efficacy Measure-Short Form [Срок оценки: Change from week one of study treatment to post-treatment following final session, an average of 25 weeks after week one (measured at weeks one, six, and twenty), and to the six-month follow-up session, up to 11 months after week one.]
• Approach/Avoidance of Weighing Questionnaire (AAWQ) [Срок оценки: Change from baseline assessed at screen visit to post-treatment following final session, an average of 25 weeks after baseline assessment.]
• Three Factor Eating Questionnaire (TFEQ) - Restriction subscale [Срок оценки: Change from baseline assessed at screen visit to session 20 and post-treatment following final session, an average of 20-25 weeks after baseline assessment.]

Критерии участия

Критерии включения

• Eligible patients must meet DSM-5 criteria for anorexia nervosa. This diagnosis can be conferred via the EDE 17.0D.
• Age > 18
• Patients must be able to provide informed consent and comply with the study procedures.
• Patients must be able to complete computer-based self-report questionnaires with adequate accommodation, if necessary.
• Patients must have a primary care physician, Adolescent Medicine physician, or consulting physician with eating disorder expertise at Massachusetts General Hospital/Massachusetts General Brigham network who can provide ongoing medical monitoring while the patient takes part in the study.

Критерии исключения

Patients will be excluded if they exhibit:

• BMI < 15, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
• HR <55 or >100, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
• Systolic BP (SBP and DBP) <80 or >160, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
• Temperature < 96.5 F, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
• Not eating food by mouth and/or any tube feeding, per EDE
• Purging > 4x/week, per EDE.
• Active suicidality (suicidal ideation with intent or plan) to the point that more intensive treatment (i.e. acute hospitalization) is required
• Active untreated and unstable bipolar disorder (i.e. stable bipolar disorder under care of a psychiatrist is allowed)
• Psychosis
• Intellectual disability
• Any condition that, after the baseline evaluation, is determined to preclude treatment with CBT.
• Concurrent psychotherapy. Patients must be willing to take a pause from any ongoing psychotherapy in order to focus on CBT-AN-20, which is in alignment with standard clinical care.
• Symptoms that are not appropriate for outpatient level of care and therefore require a higher level of care (i.e. BMI <15 or purging more than 4x/week)
• Homicidal ideation
• Inability to speak English well enough to engage in CBT

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

• Eating Disorders Clinical and Research Program — Boston

Идентификаторы

NCT: NCT06597305 · 2023P002713

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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