Anorexia NervosaNCT06597305
Evaluation of a Twenty-session Cognitive-behavioral Therapy With Anorexia Nervosa (CBT-20-AN) Among Adults (18+)
A study testing Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN) in people with Anorexia Nervosa and Atypical Anorexia Nervosa, run by Massachusetts General Hospital at 1 site in United States.
Trial 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) and atypical anorexia nervosa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorexia Nervosa, Atypical Anorexia Nervosa
- What is being tested?
- Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2024to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Eating Disorders Clinical and Research Program
Boston, Massachusetts, 02114
About this study
Official title: Twenty-session Cognitive-behavioral Therapy for Adults With Anorexia Nervosa (CBT-20-AN)
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.
- Conditions
- Anorexia Nervosa, Atypical Anorexia Nervosa
- Being tested
- Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN)
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient weight
Weight collected at each session.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?").
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start22 Apr 2024
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kendra R. Becker, Ph.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597305
- Sponsor's protocol ID
- 2023P002713
- Status last verified
- Jul 2026
- First submitted
- 18 Apr 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twenty-session Cognitive-behavioral Therapy for Adults With Anorexia Nervosa (CBT-20-AN)
- ClinicalTrials.gov ID
- NCT06597305
- Acronym / sponsor ID
- 2023P002713
- Conditions
- Anorexia Nervosa, Atypical Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT-20-AN | Experimental | Behavioral: Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CBT-20-AN |
Primary outcome
Patient weight
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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?").
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN) in people with Anorexia Nervosa and Atypical Anorexia Nervosa, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient weight (time frame: 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.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.