AnorexiaNCT05708404
Outpatient Treatment of Severe and Enduring Anorexia Nervosa
An observational study of Anorexia, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Approximately 20-30 % of individuals with the eating disorder anorexia nervosa develop an enduring form of the illness. In this study a new treatment for patients with severe and enduring anorexia nervosa was described. The treatment is flexible and aims at enhancing quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anorexia
- What is being tested?
- Outpatient treatment of severe and enduring anorexia nervosa
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 1 May 2017to 31 May 2022
- Phase
- Observational
- 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 years and older
- Women only
- Adult, Older adult
Study population: Adult women with severe and enduring anorexia nervosa.
Who may be able to join
- Age ≥ 18 years
- A referral resulting in an assessment or treatment period at the unit for patients with severe and enduring anorexia nervosa at the HUS Helsinki University Hospital between May 2017 and May 2022.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Outpatient Treatment for Patients With Severe and Enduring Anorexia Nervosa: Patient Characteristics, Treatment Goals, and Course of Treatment.
Approximately 20-30 % of individuals with the eating disorder anorexia nervosa develop an enduring form of the illness. In this study a new treatment for patients with severe and enduring anorexia nervosa was described. The treatment is flexible and aims at enhancing quality of life. The participants consisted of all referrals resulting in an assessment or treatment period at the unit between May 2017 and May 2022. The study was a registry study. Information regarding patient characteristics, treatment goals, and the course of treatment was gathered from medical records.
- Conditions
- Anorexia
- Being tested
- Outpatient treatment of severe and enduring anorexia nervosa
- Keywords
- Anorexia nervosa, Severe and enduring anorexia nervosa, Treatment
- Medical subject headings
- Anorexia, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient treatment of severe and enduring anorexia nervosaBehavioural
A novel outpatient treatment of severe and enduring anorexia nervosa, aiming at enhancing quality of life and minimizing harm
What is being measured
The primary outcome is the main question the study is designed to answer.
How the treatment goals were met
Whether or not the patients' individual treatment goals, defined at the beginning of treatment, had been met, partly met, or not met at the end of treatment.
Measured: At the end of treatment, an average of 15.4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 May 2017
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnorexiaStudies of the same condition, open and under way.
- More trials run by Helsinki University Central 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Algars, Helsinki University Central Hospital
- Investigators
- Jaana Suokas, Ph.D., Principal investigator, HUS Helsinki Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708404
- Sponsor's protocol ID
- PISARAAVO
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Algars M, Oshukova S, Suokas J. A novel outpatient treatment model for patients with severe and enduring anorexia nervosa: an observational study of patient characteristics, treatment goals, and treatment course. J Eat Disord. 2023 Sep 6;11(1):150. doi: 10.1186/s40337-023-00877-x.
PubMed 37674214
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Outpatient Treatment for Patients With Severe and Enduring Anorexia Nervosa: Patient Characteristics, Treatment Goals, and Course of Treatment.
- ClinicalTrials.gov ID
- NCT05708404
- Acronym / sponsor ID
- PISARAAVO
- Conditions
- Anorexia
- Keywords
- Anorexia nervosa, Severe and enduring anorexia nervosa, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 1 Feb 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.
Approximately 20-30 % of individuals with the eating disorder anorexia nervosa develop an enduring form of the illness. In this study a new treatment for patients with severe and enduring anorexia nervosa was described. The treatment is flexible and aims at enhancing quality of life. The participants consisted of all referrals resulting in an assessment or treatment period at the unit between May 2017 and May 2022. The study was a registry study. Information regarding patient characteristics, treatment goals, and the course of treatment was gathered from medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Adult women with severe and enduring anorexia nervosa.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- A referral resulting in an assessment or treatment period at the unit for patients with severe and enduring anorexia nervosa at the HUS Helsinki University Hospital between May 2017 and May 2022.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Outpatient treatment of severe and enduring anorexia nervosaA novel outpatient treatment of severe and enduring anorexia nervosa, aiming at enhancing quality of life and minimizing harm | Behavioural | – |
Primary outcome
How the treatment goals were met
Time frame: At the end of treatment, an average of 15.4 months
Whether or not the patients' individual treatment goals, defined at the beginning of treatment, had been met, partly met, or not met at the end of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Derived from this study: PubMed 37674214Algars M, Oshukova S, Suokas J. A novel outpatient treatment model for patients with severe and enduring anorexia nervosa: an observational study of patient characteristics, treatment goals, and treatment course. J Eat Disord. 2023 Sep 6;11(1):150. doi: 10.1186/s40337-023-00877-x.
- 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.
Jaana Suokas, Ph.D. principal investigator
HUS Helsinki Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia, run by Helsinki University Central Hospital at 1 site in Finland.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 1 Feb 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
How the treatment goals were met (time frame: At the end of treatment, an average of 15.4 months). 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 NCT05708404, which also lists 1 linked publication.
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 1 Feb 2023.