Clinical trial NCT06597305: Evaluation of a Twenty-session Cognitive-behavioral Therapy With Anorexia Nervosa (CBT-20-AN) Among Adults (18+)
Official title: Twenty-session Cognitive-behavioral Therapy for Adults With Anorexia Nervosa (CBT-20-AN)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is a clinical trial assessing the efficacy of a new twenty session cognitive behavioral therapy for adults (18+) with anorexia nervosa (AN). 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.


Eligibility criteria: Inclusion Criteria:

1. Eligible patients must meet DSM-5 criteria for anorexia nervosa. This diagnosis can be conferred via the EDE 17.0D.
2. Age \> 18
3. Patients must be able to provide informed consent and comply with the study procedures.
4. Patients must be able to complete computer-based self-report questionnaires with adequate accommodation, if necessary.
5. 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.

Exclusion Criteria:

Patients will be excluded if they exhibit:

1. BMI \< 15 or \> 19, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
2. HR \<55 or \>100, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
3. Systolic BP (SBP and DBP) \<80 or \>160, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
4. Temperature \< 96.5 F, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
5. Not eating food by mouth and/or any tube feeding, per EDE
6. Purging \> 4x/week, per EDE.
7. Active suicidality (suicidal ideation with intent or plan) to the point that more intensive treatment (i.e. acute hospitalization) is required
8. Active untreated and unstable bipolar disorder (i.e. stable bipolar disorder under care of a psychiatrist is allowed)
9. Psychosis
10. Intellectual disability
11. Any condition that, after the baseline evaluation, is determined to preclude treatment with CBT.
12. 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.
13. 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)
14. Homicidal ideation
15. Inability to speak English well enough to engage in CBT

Primary outcomes:
measure: Patient weight
timeFrame: 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.
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: 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.
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: 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.
measure: Eating Disorder Examination Interview (EDE)
timeFrame: Change from baseline assessed at screen visit to post-treatment following final session, an average of 25 weeks after baseline assessment.
measure: Eating Disorder Examination Questionnaire (EDE-Q6)
timeFrame: 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.
measure: Eating Disorder - 15 Scale (ED-15)
timeFrame: 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.
measure: Working Alliance Inventory Short (WAI-SR)
timeFrame: 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.
measure: General Self-Efficacy Measure-Short Form
timeFrame: 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.
measure: Approach/Avoidance of Weighing Questionnaire (AAWQ)
timeFrame: Change from baseline assessed at screen visit to post-treatment following final session, an average of 25 weeks after baseline assessment.
measure: Three Factor Eating Questionnaire (TFEQ) - Restriction subscale
timeFrame: 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.
measure: Eating Disorder Inventory-3 (EDI-3) - Drive for Thinness and Body Dissatisfaction subscales
timeFrame: 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.
measure: Clinical Impairment Assessment Questionnaire (CIA)
timeFrame: 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.
measure: Quality of life questions
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Eating Disorders Clinical and Research Program
state: Massachusetts
Study officials:
References: