Anorexia NervosaRODBT-ANNCT06050421
Radically Open Dialectical Behaviour Therapy in Patients With Anorexia Nervosa
A study testing Radically Open Dialectical Behaviour Therapy (RO-DBT) and Treatment As Usual in people with Anorexia Nervosa and Anorexia Nervosa in Remission, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Randomized controlled clinical trial to evaluate the efficacy of "Radically Open Dialectical Behaviour Therapy" in patients with eating disorders: a proof-of-concept study. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Anorexia Nervosa in Remission, Anorexia Nervosa Restricting Type
- What is being tested?
- Radically Open Dialectical Behaviour Therapy (RO-DBT) and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jun 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female patients
- aged between 18 to 65 years old,
- having a diagnosis of AN (DSM 5 criteria),
- having had weigh restoration treatment (normal BMI considered >19 kg/m2)
- having an overcontrol personality style assessed with the styles of coping Word-Pair Checklist scale (ASC-WP)
Who cannot join
- diagnosis of severe mental illness (schizophrenia or other psychosis, bipolar disorder, major depressive disorder, substance use disorder)
- diagnosis of borderline personality disorder (BPD) or positive result in McLean Screening Instrument for BPD
- mental retardation
- being under standardized psychotherapy at the baseline
- being illiterate or not able to understand Spanish language,
- being left-handed
- being pregnant for MRI requirements.
Trial locations and contacts
1 site in 1 country.
Aina Avila contact
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Cristina Carmona, Phd, +34935537813, ccarmonaf@santpau.cat
Cristina Carmona, Phd, 650003427, ccarmonaf@santpau.cat
About this study
Official title: Evaluating the Efficacy of Radically Open Dialectical Behaviour Therapy (RO-DBT) in Patients With Anorexia Nervosa: a Randomized Controlled Clinical Trial
Randomized controlled clinical trial to evaluate the efficacy of "Radically Open Dialectical Behaviour Therapy" in patients with eating disorders: a proof-of-concept study.
Read the detailed description
Background: Up to 20% of patients with anorexia nervosa (AN) die and 50% relapse after the first episode, being its treatment a great challenge for clinicians. Most therapies excessively focus excessively on nourishment, which translates to temporarily restored weight with no improvements in psychosocial life. Radically Open Dialectical Behaviour Therapy (RO-DBT) is a transdiagnostic treatment designed to treat overcontrol, a key aspect in the functioning of patients with AN. To date no clinical trial (CT) has proved its efficacy on these patients or has demonstrated its biological underpinning mechanisms.
Methods: A randomized CT in AN patients will be conducted, where one group will receive treatment as usual (TAU) and the other one TAU with plus RO-DBT, being psychosocial adjustment the main outcome; other secondary variables will be ED symptoms, overcontrol characteristics, autistic traits and neuroimaging changes.
Discussion: The results will fill the a knowledge gap in AN treatment, expecting that patients who receive TAU with RO-DBT will have better social adjustment and less relapses at one year follow up. This is the first study examining neuroimaging changes in RO-DBT to better understand its underlying mechanisms
- Being tested
- Radically Open Dialectical Behaviour Therapy (RO-DBT), Treatment As Usual, No intervention
- Keywords
- anorexia nervosa, RODBT
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radically Open Dialectical Behaviour Therapy (RO-DBT)Behavioural
Also called non
RO-DBT is a transdiagnostic intervention specifically designed to treat a spectrum of disorders characterized by excessive overcontrol such as resistant depression, avoidant and obsessive-compulsive personality disorders, mood disorders, anorexia nervosa and autism spectrum disorder.
Treatment As UsualOther
he TAU condition will follow the standard treatment of the EDs Unit of the HSCSP for AN. This treatment consists of visits with a psychiatrist with a frequency decided according to the clinical situation and, in some cases, nursing follow-up and/or relapse prevention group that takes place twice per month
No interventionOther
All controls will complete data collection notebook and will undergo the same neuroimaging acquisition. There will not be follow-up for this group.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | Other | The TAU condition will follow the standard treatment of the EDs Unit of the HSCSP for AN. This treatment consists of visits with a psychiatrist with a frequency decided according to the clinical situation and, in some cases, nursing follow-up and/or relapse prevention group that takes place twice per month Receives: Other: Treatment As Usual |
| TAU + Radically Open Dialectical Behaviour Therapy (RO-DBT) | Experimental | 2. TAU + skills of the RO-DBT: In this treatment branch, a RO-DBT skills training therapy will be added to TAU. Treatment and therapists: RO DBT skills training consists of a 30-week intervention program in which a set of skills specifically designed to treat overcontrol are taught on an ongoing basis. The duration of each session is 2 hours. Table X provides an overall summary of each skill training session content. Detailed and extensive information about the treatment can be found elsewhere [24], [34]. Three clinical psychologists and one psychiatrist will conduct the treatment, all of whom have undergone extensive training in RO DBT. A maximum of two therapists will be in charge of each session, and the same two therapists will go throughout each group intervention. The team will be supervised by an approved RO DBT supervisor to improve therapeutic skills and ensure adherence to the protocol. Receives: Behavioral: Radically Open Dialectical Behaviour Therapy (RO-DBT) |
| Healty controls | Other | All controls will complete data collection notebook and will undergo the same neuroimaging acquisition. There will not be follow-up for this group. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q
A self report questionarie that assesses quality of life. The range of scores is 0-100. Higher scores mean higher quality of life.
Measured: 6 months
Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q
A self report questionarie that assesses quality of life. The range of scores is 0-100. Higher scores mean higher quality of life.
Measured: 12 months
Secondary outcomes (10)
Clinical relapses
having BMI below 19kg/m2 during two or more weeks, and having a punctuation of the EAT above 21.
Measured: 6 months, 12 months
Eating Disorder Inventory, EDI
A self report questionarie that assesses eating disorder symptomatology. The range of scores is 0-192. Higher scores mean higher eating disorders sympthoms
Measured: 6 months, 12 monghs
Autism-Spectrum Quotient, AQ
A self report questionarie that assesses autistic traits. The range of scores is 0 to 50. Higher scores mean higher autistic traits.
Measured: 6 months, 12 months
Rosenberg Self-Esteem Scale, RSE.
A self report questionarie that assesses self steem. The scale ranges from 0-30. Higher scores mean higher self-esteem. The range scores is 0-60.
Measured: 6 months, 12 months
Inventory of Interpersonal Problems (IIP-64)
A screening measure for avoidant personality disorder (AVPD), and for personality disorder (PD) in general.
Measured: 6 months, 12 months
Social Connectedness Scale-Revised, SCS-R
This scale assesses the degree to which a person feel connected to others in their social environment. Scores range from 20 to 120 higher score indicates more connectedness to others.
Measured: 6 months, 12 months
Depression Anxiety and Stress Scale 21 (DASS-21)
A self-report scale designed to measure the negative emotional states of depression, anxiety and stress.
Measured: 6 months, 12 months
Neuroimaging variables
structural and functional magnetic resonance images will be acquired at baseline and at 1- month follow-up for all the participants, and in one single occasion for the healthy control group.
Measured: 6 months, 12 months
Clinical Outcomes in Routine Evaluation-Outcome Measure, CORE-OM,
A self-report measure of psychological distress designed to be administered during a course of treatment to determine treatment response. The broad spectrum nature of the measure means it captures a wide variety of problems associated with mental health difficulties, beyond typical symptom measures.
Measured: 6 months, 12 months
Assessed with the Questionnaire envy in adults, CEA
This is composed of 24 items representing all theoretical dimensions. Higher scores show higher envy.
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start22 Jun 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació La Marató de TV3
- Responsible party
- Sponsor
- Investigators
- Cristina Carmona, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050421
- Sponsor's protocol ID
- IIBSP-TDC-2022-123
- Acronym
- RODBT-AN
- Status last verified
- Sep 2023
- First submitted
- 15 Jun 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lynch TR, Gray KL, Hempel RJ, Titley M, Chen EY, O'Mahen HA. Radically open-dialectical behavior therapy for adult anorexia nervosa: feasibility and outcomes from an inpatient program. BMC Psychiatry. 2013 Nov 7;13:293. doi: 10.1186/1471-244X-13-293.
PubMed 24199611Chen EY, Segal K, Weissman J, Zeffiro TA, Gallop R, Linehan MM, Bohus M, Lynch TR. Adapting dialectical behavior therapy for outpatient adult anorexia nervosa--a pilot study. Int J Eat Disord. 2015 Jan;48(1):123-32. doi: 10.1002/eat.22360. Epub 2014 Oct 27.
PubMed 25346237Isaksson M, Ghaderi A, Ramklint M, Wolf-Arehult M. Radically open dialectical behavior therapy for anorexia nervosa: A multiple baseline single-case experimental design study across 13 cases. J Behav Ther Exp Psychiatry. 2021 Jun;71:101637. doi: 10.1016/j.jbtep.2021.101637. Epub 2021 Jan 12.
PubMed 33524917Avila-Parcet A, Martin-Blanco A, Gawron L, Cano M, Pena-Arteaga V, Carceller-Sindreu M, Soler J, Portella MJ, Faustino G, Cardoner N, Carmona I Farres C. Evaluating the efficacy of radically open dialectical behavior therapy (RO-DBT) in patients with anorexia nervosa: study protocol for a randomized controlled clinical trial. BMC Psychiatry. 2025 Apr 18;25(1):403. doi: 10.1186/s12888-025-06854-9.
PubMed 40251556
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Radically Open Dialectical Behaviour Therapy (RO-DBT) in Patients With Anorexia Nervosa: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06050421
- Acronym / sponsor ID
- RODBT-AN / IIBSP-TDC-2022-123
- Keywords
- anorexia nervosa, RODBT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Fundació La Marató de TV3
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Sep 2023 (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.
Randomized controlled clinical trial to evaluate the efficacy of "Radically Open Dialectical Behaviour Therapy" in patients with eating disorders: a proof-of-concept study.
Detailed description
Background: Up to 20% of patients with anorexia nervosa (AN) die and 50% relapse after the first episode, being its treatment a great challenge for clinicians. Most therapies excessively focus excessively on nourishment, which translates to temporarily restored weight with no improvements in psychosocial life. Radically Open Dialectical Behaviour Therapy (RO-DBT) is a transdiagnostic treatment designed to treat overcontrol, a key aspect in the functioning of patients with AN. To date no clinical trial (CT) has proved its efficacy on these patients or has demonstrated its biological underpinning mechanisms.
Methods: A randomized CT in AN patients will be conducted, where one group will receive treatment as usual (TAU) and the other one TAU with plus RO-DBT, being psychosocial adjustment the main outcome; other secondary variables will be ED symptoms, overcontrol characteristics, autistic traits and neuroimaging changes.
Discussion: The results will fill the a knowledge gap in AN treatment, expecting that patients who receive TAU with RO-DBT will have better social adjustment and less relapses at one year follow up. This is the first study examining neuroimaging changes in RO-DBT to better understand its underlying mechanisms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | Other | Other: Treatment As UsualThe TAU condition will follow the standard treatment of the EDs Unit of the HSCSP for AN. This treatment consists of visits with a psychiatrist with a frequency decided according to the clinical situation and, in some cases, nursing follow-up and/or relapse prevention group that takes place twice per month |
| TAU + Radically Open Dialectical Behaviour Therapy (RO-DBT) | Experimental | Behavioral: Radically Open Dialectical Behaviour Therapy (RO-DBT)2. TAU + skills of the RO-DBT: In this treatment branch, a RO-DBT skills training therapy will be added to TAU. Treatment and therapists: RO DBT skills training consists of a 30-week intervention program in which a set of skills specifically designed to treat overcontrol are taught on an ongoing basis. The duration of each session is 2 hours. Table X provides an overall summary of each skill training session content. Detailed and extensive information about the treatment can be found elsewhere [24], [34]. Three clinical psychologists and one psychiatrist will conduct the treatment, all of whom have undergone extensive training in RO DBT. A maximum of two therapists will be in charge of each session, and the same two therapists will go throughout each group intervention. The team will be supervised by an approved RO DBT supervisor to improve therapeutic skills and ensure adherence to the protocol. |
| Healty controls | Other | Other: No interventionAll controls will complete data collection notebook and will undergo the same neuroimaging acquisition. There will not be follow-up for this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- female patients
- aged between 18 to 65 years old,
- having a diagnosis of AN (DSM 5 criteria),
- having had weigh restoration treatment (normal BMI considered >19 kg/m2)
- having an overcontrol personality style assessed with the styles of coping Word-Pair Checklist scale (ASC-WP)
Key exclusion criteria (7 listed)
- diagnosis of severe mental illness (schizophrenia or other psychosis, bipolar disorder, major depressive disorder, substance use disorder)
- diagnosis of borderline personality disorder (BPD) or positive result in McLean Screening Instrument for BPD
- mental retardation
- being under standardized psychotherapy at the baseline
- being illiterate or not able to understand Spanish language,
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 |
|---|---|---|
| Radically Open Dialectical Behaviour Therapy (RO-DBT)Also: nonRO-DBT is a transdiagnostic intervention specifically designed to treat a spectrum of disorders characterized by excessive overcontrol such as resistant depression, avoidant and obsessive-compulsive personality disorders, mood disorders, anorexia nervosa and autism spectrum disorder. | Behavioural | TAU + Radically Open Dialectical Behaviour Therapy (RO-DBT) |
| Treatment As Usualhe TAU condition will follow the standard treatment of the EDs Unit of the HSCSP for AN. This treatment consists of visits with a psychiatrist with a frequency decided according to the clinical situation and, in some cases, nursing follow-up and/or relapse prevention group that takes place twice per month | Other | Treatment as Usual (TAU) |
| No interventionAll controls will complete data collection notebook and will undergo the same neuroimaging acquisition. There will not be follow-up for this group. | Other | Healty controls |
Primary outcome
Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q
Time frame: 6 months
A self report questionarie that assesses quality of life. The range of scores is 0-100. Higher scores mean higher quality of life.
Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q
Time frame: 12 months
A self report questionarie that assesses quality of life. The range of scores is 0-100. Higher scores mean higher quality of life.
10 secondary outcomes
Clinical relapses
Time frame: 6 months, 12 months
Eating Disorder Inventory, EDI
Time frame: 6 months, 12 monghs
Autism-Spectrum Quotient, AQ
Time frame: 6 months, 12 months
Rosenberg Self-Esteem Scale, RSE.
Time frame: 6 months, 12 months
Inventory of Interpersonal Problems (IIP-64)
Time frame: 6 months, 12 months
Social Connectedness Scale-Revised, SCS-R
Time frame: 6 months, 12 months
Depression Anxiety and Stress Scale 21 (DASS-21)
Time frame: 6 months, 12 months
Neuroimaging variables
Time frame: 6 months, 12 months
Clinical Outcomes in Routine Evaluation-Outcome Measure, CORE-OM,
Time frame: 6 months, 12 months
Assessed with the Questionnaire envy in adults, CEA
Time frame: 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Background: PubMed 24199611Lynch TR, Gray KL, Hempel RJ, Titley M, Chen EY, O'Mahen HA. Radically open-dialectical behavior therapy for adult anorexia nervosa: feasibility and outcomes from an inpatient program. BMC Psychiatry. 2013 Nov 7;13:293. doi: 10.1186/1471-244X-13-293.
- Background: PubMed 25346237Chen EY, Segal K, Weissman J, Zeffiro TA, Gallop R, Linehan MM, Bohus M, Lynch TR. Adapting dialectical behavior therapy for outpatient adult anorexia nervosa--a pilot study. Int J Eat Disord. 2015 Jan;48(1):123-32. doi: 10.1002/eat.22360. Epub 2014 Oct 27.
- Background: PubMed 33524917Isaksson M, Ghaderi A, Ramklint M, Wolf-Arehult M. Radically open dialectical behavior therapy for anorexia nervosa: A multiple baseline single-case experimental design study across 13 cases. J Behav Ther Exp Psychiatry. 2021 Jun;71:101637. doi: 10.1016/j.jbtep.2021.101637. Epub 2021 Jan 12.
- Derived from this study: PubMed 40251556Avila-Parcet A, Martin-Blanco A, Gawron L, Cano M, Pena-Arteaga V, Carceller-Sindreu M, Soler J, Portella MJ, Faustino G, Cardoner N, Carmona I Farres C. Evaluating the efficacy of radically open dialectical behavior therapy (RO-DBT) in patients with anorexia nervosa: study protocol for a randomized controlled clinical trial. BMC Psychiatry. 2025 Apr 18;25(1):403. doi: 10.1186/s12888-025-06854-9.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Aina Avila contact
Cristina Carmona principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radically Open Dialectical Behaviour Therapy (RO-DBT) and Treatment As Usual in people with Anorexia Nervosa and Anorexia Nervosa in Remission, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 7 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: status not confirmed, as of the sponsor's last update on 22 Sep 2023. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Carmona, Doctor (0034650003427, ccarmonaf@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06050421, which also lists 4 linked publications.
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 22 Sep 2023.