Eating DisordersSEEDNCT02897622
Severe and Enduring Eating Disorder Patients at Stockholms Center for Eating Disorders in Sweden
A study testing Case management in people with Eating Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Patients with severe and enduring eating disorders (SEED) are seriously ill and have a low quality of life. In 2014, a special unit based on case management (CM), for patients with SEED (the Eira unit) was started at Stockholm Centre for Eating Disorders, Sweden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Case management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2014to Jan 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis: eating disorder according to DSM IV (Diagnostic and statistical manual of mental disorders fourth edition) Criteria based on diagnostic interview
- Illness duration of ED >10
- Participated in at least three failed specialized eating disorder treatments
- Written informed consent
- Having the mental capacity to make provide informed consent to research participation
- Somatically stable
Who cannot join
- Somatically unstable
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Maja Molin
Stockholm
Yvonne von Hausswolff-Juhlin, Md/PhD, +46812344186, yvonne.vonhausswolff-juhlin@ki.se
About this study
Patients with severe and enduring eating disorders (SEED) are seriously ill and have a low quality of life. In 2014, a special unit based on case management (CM), for patients with SEED (the Eira unit) was started at Stockholm Centre for Eating Disorders, Sweden. Eating disorder is a serious illness that creates a great deal of suffering. Most patients who undergo specialized eating disorder treatment will be healthy, but a small percentage of the patients develop a SEED. SEED patient have gone through numerous of treatments and has been to several specialists units for years as well as they has completed many different therapies without getting fee from the eating disorder (ED). Due to the long term sick in ED the SEED patient is often alone and has difficulties to cope with everyday life situations. SEED patients are a vulnerable patient population with a great suffering and poverty to release the identity of the ED. However, no previous study is done in which patients with SEED themselves describe their own theory about why they are still ill and how specialized eating disorder care has affected them. In the ED field, there is a growing consensus that treatment of patients with SEED needs to be multi-professional, with a focus on improving the patients' social situation, minimizing medical complications, and enhancing quality of life and independence, rather than focusing one-sided on symptom reduction. Is case management a way to help the SEED patients witness a better quality of life? Besides the personal suffering of patients and their families, SEED is also associated with high costs for health care and for society in general.
Read the detailed description
- This is a qualitative study based on semi-structured interviews with 21 patients with SEED. Grounded theory was used to analyse data. The patients had suffered from eating disorders on average for 21,5 years with a BMI of 15,4 (12,2-19.5) at the time for the interview.
- Methods for data collection are a semi-structured diagnostic interview, a qualitative interview, self-report questionnaires and data from medical records. The diagnostic interview and the self-report assessments will be done at start of treatment and at follow-ups after one, two, and three years. The qualitative interview will be conducted one year after start of treatment. Data from medical records will be collected retrospectively.
The Structured Eating Disorder Interview (SEDI) is a semi-structured diagnostic interview for ED diagnoses according to the DSM-IV. The interview consists of a maximum of 30 and normally about 20-25 questions.
The RAND-36 (also known as the SF-36) measures health-related quality of life (HRQoL). Changes in the HRQoL over time can be seen by comparing repeated assessments.
The Eating Disorder Examination Questionnaire (EDE-Q) measures central symptomatic aspects of ED by way of patient's self-ratings.
The Treatment Satisfaction Scale 2 (TSS-2) is a patient-rated assessment of treatment satisfaction in a simple 6-item scale. TSS-2 will be used at all follow-ups.
The qualitative interview is semi-structured and consists of three broad themes:
- The patient's thoughts about her/his life situation in the year he/she has been at Eira.
- The patient's thoughts and reflections about her/his quality of life, and whether it has been affected in the year he/she has been at Eira.
- The patient's thoughts about her/his future. The informants will be asked to talk openly around these themes. The interviewer, who is the same person for all interviews, is a psychologist who is not part of the Eira staff.
- The cost-effectiveness analysis consists of costs of the CM intervention, changes in quality of life, as well as societal costs such as health care usage and loss of production. The perspective of the analysis will be societal and the time horizon three years. The analysis method is going to be cost-utility analysis with health effect expressed in quality adjusted life years (QALY). The analysis will be complemented with the probability of acceptable cost-effectiveness with different willingness to pay for a QALY.
All costs of the CM intervention occur at Eira. The cost for each patient in the study can be calculated by Eira's total cost divided with each patient's share of resource utilization based on enrolled time.
QALYs will be estimated based on RAND-36 transformed to SF-6D based on a British preference score. From the measures at baseline, and after 1, 2 and 3 years, changes in QALYs can be estimated. From medical records, changes in cost of health care usage can be calculated. The participants' employment and change acquisition work rate is followed during the same period based on interviews with participants.
The treatment may also have impact on relatives' quality of life, costs and earnings. These aspects will not be considered in the analysis.
Setting
During the first 5-6 sessions at Eira, the patient's psychiatric, somatic and social condition is carefully investigated as well as her/his medical history and previous treatment experiences. Thereafter the CM intervention starts. The patients' needs and preferences guides where and how often the meetings take place and some can be done by phone or text messages. Another important part of the CM is to help the patients contact the authorities and if necessary to aid them with economic issues.
In addition to the supportive interventions is it also important to regularly monitor the somatic condition and the weight of the patients. If the patient is temporarily in need of more somatic or psychiatric help, the therapists can help in planning a short, more intensive treatment.
Twice a year, there is a lecture about the SEED condition for the relatives (without the patients) at Eira. During the lecture the relatives can ask questions and discuss problems they encounter as SEED relatives. With the patients' consent, relatives are invited to participate in the CM treatment. Information and support is offered relatives on an individual basis, this also includes underage children.
- Conditions
- Eating Disorders
- Being tested
- Case management
- Keywords
- Eating disorders, severe and enduring, quality of life, case management
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case managementOther
Case management by Eira unit
| Study group | Role | What they receive |
|---|---|---|
| Case management | Other | Case management Receives: Other: Case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients experience of specialized eating disorder care
By semi structured interviews
Measured: up to 5 years
Secondary outcomes (2)
Quality of life
RAND-36
Measured: up to 5 years
Cost-effectiveness
RAND-36
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startApr 2014
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
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 Eating DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yvonne von Hausswolff-Juhlin, Karolinska Institutet
- Investigators
- Yvonne von Hausswolff-Juhlin, MdPhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897622
- Sponsor's protocol ID
- Eira
- Acronym
- SEED
- Status last verified
- Sep 2016
- First submitted
- 12 Aug 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Molin M, von Hausswolff-Juhlin Y, Norring C, Hagberg L, Gustafsson SA. Case management at an outpatient unit for severe and enduring eating disorder patients at Stockholm Centre for Eating Disorders- a study protocol. J Eat Disord. 2016 Oct 26;4:24. doi: 10.1186/s40337-016-0121-3. eCollection 2016.
PubMed 27800159
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe and Enduring Eating Disorder Patients at Stockholms Center for Eating Disorders in Sweden
- ClinicalTrials.gov ID
- NCT02897622
- Acronym / sponsor ID
- SEED / Eira
- Conditions
- Eating Disorders
- Keywords
- Eating disorders, severe and enduring, quality of life, case management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 13 Sep 2016 (estimated)
- 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.
Patients with severe and enduring eating disorders (SEED) are seriously ill and have a low quality of life. In 2014, a special unit based on case management (CM), for patients with SEED (the Eira unit) was started at Stockholm Centre for Eating Disorders, Sweden. Eating disorder is a serious illness that creates a great deal of suffering. Most patients who undergo specialized eating disorder treatment will be healthy, but a small percentage of the patients develop a SEED. SEED patient have gone through numerous of treatments and has been to several specialists units for years as well as they has completed many different therapies without getting fee from the eating disorder (ED). Due to the long term sick in ED the SEED patient is often alone and has difficulties to cope with everyday life situations. SEED patients are a vulnerable patient population with a great suffering and poverty to release the identity of the ED. However, no previous study is done in which patients with SEED themselves describe their own theory about why they are still ill and how specialized eating disorder care has affected them. In the ED field, there is a growing consensus that treatment of patients with SEED needs to be multi-professional, with a focus on improving the patients' social situation, minimizing medical complications, and enhancing quality of life and independence, rather than focusing one-sided on symptom reduction. Is case management a way to help the SEED patients witness a better quality of life? Besides the personal suffering of patients and their families, SEED is also associated with high costs for health care and for society in general.
Detailed description
- This is a qualitative study based on semi-structured interviews with 21 patients with SEED. Grounded theory was used to analyse data. The patients had suffered from eating disorders on average for 21,5 years with a BMI of 15,4 (12,2-19.5) at the time for the interview.
- Methods for data collection are a semi-structured diagnostic interview, a qualitative interview, self-report questionnaires and data from medical records. The diagnostic interview and the self-report assessments will be done at start of treatment and at follow-ups after one, two, and three years. The qualitative interview will be conducted one year after start of treatment. Data from medical records will be collected retrospectively.
The Structured Eating Disorder Interview (SEDI) is a semi-structured diagnostic interview for ED diagnoses according to the DSM-IV. The interview consists of a maximum of 30 and normally about 20-25 questions.
The RAND-36 (also known as the SF-36) measures health-related quality of life (HRQoL). Changes in the HRQoL over time can be seen by comparing repeated assessments.
The Eating Disorder Examination Questionnaire (EDE-Q) measures central symptomatic aspects of ED by way of patient's self-ratings.
The Treatment Satisfaction Scale 2 (TSS-2) is a patient-rated assessment of treatment satisfaction in a simple 6-item scale. TSS-2 will be used at all follow-ups.
The qualitative interview is semi-structured and consists of three broad themes:
- The patient's thoughts about her/his life situation in the year he/she has been at Eira.
- The patient's thoughts and reflections about her/his quality of life, and whether it has been affected in the year he/she has been at Eira.
- The patient's thoughts about her/his future. The informants will be asked to talk openly around these themes. The interviewer, who is the same person for all interviews, is a psychologist who is not part of the Eira staff.
- The cost-effectiveness analysis consists of costs of the CM intervention, changes in quality of life, as well as societal costs such as health care usage and loss of production. The perspective of the analysis will be societal and the time horizon three years. The analysis method is going to be cost-utility analysis with health effect expressed in quality adjusted life years (QALY). The analysis will be complemented with the probability of acceptable cost-effectiveness with different willingness to pay for a QALY.
All costs of the CM intervention occur at Eira. The cost for each patient in the study can be calculated by Eira's total cost divided with each patient's share of resource utilization based on enrolled time.
QALYs will be estimated based on RAND-36 transformed to SF-6D based on a British preference score. From the measures at baseline, and after 1, 2 and 3 years, changes in QALYs can be estimated. From medical records, changes in cost of health care usage can be calculated. The participants' employment and change acquisition work rate is followed during the same period based on interviews with participants.
The treatment may also have impact on relatives' quality of life, costs and earnings. These aspects will not be considered in the analysis.
Setting
During the first 5-6 sessions at Eira, the patient's psychiatric, somatic and social condition is carefully investigated as well as her/his medical history and previous treatment experiences. Thereafter the CM intervention starts. The patients' needs and preferences guides where and how often the meetings take place and some can be done by phone or text messages. Another important part of the CM is to help the patients contact the authorities and if necessary to aid them with economic issues.
In addition to the supportive interventions is it also important to regularly monitor the somatic condition and the weight of the patients. If the patient is temporarily in need of more somatic or psychiatric help, the therapists can help in planning a short, more intensive treatment.
Twice a year, there is a lecture about the SEED condition for the relatives (without the patients) at Eira. During the lecture the relatives can ask questions and discuss problems they encounter as SEED relatives. With the patients' consent, relatives are invited to participate in the CM treatment. Information and support is offered relatives on an individual basis, this also includes underage children.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case management | Other | Other: Case managementCase management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary diagnosis: eating disorder according to DSM IV (Diagnostic and statistical manual of mental disorders fourth edition) Criteria based on diagnostic interview
- Illness duration of ED >10
- Participated in at least three failed specialized eating disorder treatments
- Written informed consent
- Having the mental capacity to make provide informed consent to research participation
Key exclusion criteria (1 listed)
- Somatically unstable
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 |
|---|---|---|
| Case managementCase management by Eira unit | Other | Case management |
Primary outcome
Patients experience of specialized eating disorder care
Time frame: up to 5 years
By semi structured interviews
2 secondary outcomes
Quality of life
Time frame: up to 5 years
Cost-effectiveness
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Derived from this study: PubMed 27800159Molin M, von Hausswolff-Juhlin Y, Norring C, Hagberg L, Gustafsson SA. Case management at an outpatient unit for severe and enduring eating disorder patients at Stockholm Centre for Eating Disorders- a study protocol. J Eat Disord. 2016 Oct 26;4:24. doi: 10.1186/s40337-016-0121-3. eCollection 2016.
- 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.
Yvonne von Hausswolff-Juhlin, MdPhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case management in people with Eating Disorders, run by Karolinska Institutet at 1 site in Sweden.
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 6 inclusion and 1 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 13 Sep 2016. 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 Sweden. 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 Maja Molin, PhD stud (+467812344095, maja.molin@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients experience of specialized eating disorder care (time frame: up to 5 years). 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 NCT02897622, 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 13 Sep 2016.