Twenty-session Cognitive-behavioral Therapy for Adults With Anorexia Nervosa (CBT-20-AN)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Patient weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients must meet DSM-5 criteria for anorexia nervosa. This diagnosis can be conferred via the EDE 17.0D.
- •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.
排除标准
- •Patients will be excluded if they exhibit:
- •BMI < 15, obtained via patient medical chart or from study 2023P000469 or 2018P
- •HR <55 or >100, obtained via patient medical chart or from study 2023P000469 or 2018P
- •Systolic BP (SBP and DBP) <80 or >160, obtained via patient medical chart or from study 2023P000469 or 2018P
- •Temperature < 96.5 F, obtained via patient medical chart or from study 2023P000469 or 2018P
- •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)
- •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
研究组 & 干预措施
CBT-20-AN
The single CBT-20-AN arm of this study is experimental, consisting of 20 weekly sessions and one-month, three-month, and six-month follow-ups.
干预措施: Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN) (Behavioral)
结局指标
主要结局
Patient weight
时间窗: 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.
Weight collected at each session.
Generalized Anxiety Disorder (GAD-7)
时间窗: 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.
A 7-item scale that measures symptoms of Generalized Anxiety Disorder (GAD), such as feeling anxious or nervous, having trouble relaxing, irritability, and feelings of dread. Scores range from 0 to 21, with higher scores reflecting higher general anxiety.
Patient Health Questionnaire - 9 (PHQ-9)
时间窗: 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.
A 9-item scale that measures symptoms of depression. Scores range from 0 to 27, with higher scores reflecting higher depression.
Eating Disorder Examination Interview (EDE)
时间窗: Change from baseline assessed at screen visit to post-treatment following final session, an average of 25 weeks after baseline assessment.
A semi-structured interview designed to assess current eating disorder psychopathology.
Eating Disorder Examination Questionnaire (EDE-Q6)
时间窗: 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.
A 33-item self-report questionnaire that assesses the presence of eating disorders symptoms in the past 28 days. Eating Disorder examination questionnaire (EDE-Q 6.0) Scores range from 0 to 6, with higher scores reflecting higher eating disorder behaviors and attitudes.
Eating Disorder - 15 Scale (ED-15)
时间窗: 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.
A 15-item self-report measure that assesses eating disorder symptoms and behaviors, designed to measure session-by-session change for clinical and research purposes. Scores range from 0 to 6, with higher scores reflecting higher disordered eating attitudes and behaviors.
Working Alliance Inventory Short (WAI-SR)
时间窗: 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.
A 12-item self-report measure that assess therapeutic alliance between the patient and therapist. (i.e., how comfortable the patient feels with the therapist, how much they trust the therapist, how much they feel the therapist is working towards their desired treatment goals, etc.). Scores range from 5 to 20, with higher scores reflecting higher therapeutic alliance.
General Self-Efficacy Measure-Short Form
时间窗: 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.
A 6-item, short form assessment of the patient's perception of their own general self-efficacy. Scores range from 10 to 40, with higher scores reflecting higher self-efficacy.
Approach/Avoidance of Weighing Questionnaire (AAWQ)
时间窗: Change from baseline assessed at screen visit to post-treatment following final session, an average of 25 weeks after baseline assessment.
A 9-item, self-report questionnaire that assesses approach and avoidance weighing tendencies. Items 1-3 are summed to provide the approach weighing tendency subscale and items 4-6 are summed to provide the avoidance weighing tendency subscale, with scores ranging from 3-18. Higher scores on each subscale indicate a higher degree of that subscale's weighing tendency.
Three Factor Eating Questionnaire (TFEQ) - Restriction subscale
时间窗: 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.
An 18-item, self-report questionnaire that assesses the presence and severity of restriction.
Eating Disorder Inventory-3 (EDI-3) - Drive for Thinness and Body Dissatisfaction subscales
时间窗: 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.
Subscales from the self-report EDI-3 questionnaire that will be used to assess the presence of both drive for thinness and body dissatisfaction. The drive for thinness subscale is 7 items and body dissatisfaction subscale is 10 items.
Clinical Impairment Assessment Questionnaire (CIA)
时间窗: 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.
A 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features.
Quality of life questions
时间窗: Change from week six 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.
A set of two qualitative questions, developed by the study team, which assess improvements in quality of life since starting treatment ("How has your life improved since beginning treatment?") and areas still needing improvement ("What areas of your life could still be improved?").
次要结局
未报告次要终点
研究者
Kendra R. Becker, Ph.D.
Eating Disorder Clinical and Research Program (EDCRP) Director of Translational Research/Associate Professor of Psychiatry
Massachusetts General Hospital