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

NCT06597305 | Enrolling By Invitation

• 1 other identifier: 2023P002713
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (13)

• Patient weight

  Weight collected at each session.

  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)

  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.

  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)

  A 9-item scale that measures symptoms of depression. Scores range from 0 to 27, with higher scores reflecting higher depression.

  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)

  A semi-structured interview designed to assess current eating disorder psychopathology.

  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)

  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.

  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)

  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.

  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)

  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.

  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

  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.

  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)

  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.

  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

  An 18-item, self-report questionnaire that assesses the presence and severity of restriction.

  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.

• Eating Disorder Inventory-3 (EDI-3) - Drive for Thinness and Body Dissatisfaction subscales

  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.

  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.

• Clinical Impairment Assessment Questionnaire (CIA)

  A 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features.

  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.

• Quality of life questions

  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?").

  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.

Study Arms (1)

CBT-20-AN

EXPERIMENTAL

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.

Behavioral: Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN)

Interventions

Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN) BEHAVIORAL

Twenty session cognitive behavioral therapy for Anorexia Nervosa (CBT-20-AN) is an treatment for 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.

CBT-20-AN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients will be excluded if they exhibit:
• BMI \< 15 or \> 19, 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Eating Disorders Clinical and Research Program

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eating Disorder Clinical and Research Program (EDCRP) Director of Translational Research/Associate Professor of Psychiatry

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: September 19, 2024
• Study Start: April 22, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)