Clinical Trial: Severe and Enduring Eating Disorder Patients at Stockholms Center for Eating Disorders in Sweden

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Severe and Enduring Eating Disorder Patients at Stockholms Center for Eating Disorders in Sweden

Brief 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. 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 Summary:

  1. 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.
  2. 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:

  1. The patient's thoughts about her/his life situation in the year he/she has been at Eira. Sponsor: Karolinska Institutet

    Current Primary Outcome: Patients experience of specialized eating disorder care [ Time Frame: up to 5 years ]

    By semi structured interviews


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Quality of life [ Time Frame: up to 5 years ]
      RAND-36
    • Cost-effectiveness [ Time Frame: up to 5 years ]
      RAND-36


    Original Secondary Outcome: Same as current

    Information By: Karolinska Institutet

    Dates:
    Date Received: August 12, 2016
    Date Started: April 2014
    Date Completion: January 2021
    Last Updated: September 7, 2016
    Last Verified: September 2016