Affect school as complementary treatment in eating disorders

• Register: ISRCTN
• Last refreshed on: 17 October 2022
• Main ID: ISRCTN11278582
• Date of registration: 29/05/2018
• Prospective Registration: No
• Primary sponsor: Regional Council in Kalmar County
• Public title: Affect school as complementary treatment in eating disorders
• Scientific title: Affect school as complementary treatment in eating disorders: A randomized controlled study
• Date of first enrolment: 01/03/2018
• Target sample size: 50
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN11278582
• Study type: Interventional
• Study design: A randomized controlled study. After informed consent has been signed, baseline measures are performed, after this the participants are randomised to either the intervention group together with their usual treatment or to TAU solely. (Treatment)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Suzanne Petersson

Key inclusion & exclusion criteria

Inclusion criteria:
1. Eating disorder diagnosis
2. Swedish as spoken language
3. Aged =18 years

Exclusion criteria:
1. BMI <15 kg/m2
2. Acute state of starvation
3. Psychosis
4. Acute high level of suicidality


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Eating Disorders
Mental and Behavioural Disorders
Eating Disorders

Intervention(s)

Block-randomisation is performed by an independent researcher who is not a part of the project. Half of the participants will be randomized into the intervention Group, the Affect school, and keep their usual treatment at the clinic, and half of the participants will keep their treatment but will not receive the Affect school intervention. The Affect school is a group treatment with education and discussions on emotions. The treatment is based on a manual and consists of eight sessions during eight weeks (two hours per session).

Both treatment arms will be followed up directly after the end of the intervention, then after 6 and 12 months respectively. As there will be several rounds of the treatment (each lasting 8 weeks) the follow ups will be undertaken according this pattern until the last group (and control group) have done their 12 months follow up.

Primary Outcome(s)

1.Eating disorder symptoms using the Eating Disorder Examination Questionnaire (EDE Q),which is a self-assessment scale, symptoms are measured at baseline, after the intervention, 6 and 12 months after the end of the intervention.
2. Difficulties in Emotion Regulation Scale, brief version (DERS) with a self-assessment scale called Difficulties in Emotion Regulation Scale (DERS) at baseline, at the end of the intervention, 6 and 12 months after the end of the intervention
3. Alexithymia with the self-assessment scale Toronto Alemithymia Scale-20 (TAS-20) at baseline, after the intervention, 6 and 12 months after the end of the intervention.

The same measures and time intervals apply to the intervention and the control groups.

Secondary Outcome(s)

1. Body Mass Index (BMI) at the start of the intervention and after 12 months.
2. Eating disorder diagnoses at baseline, at 6 and 12 months after the end of the intervention

The same measures and time intervals apply to the intervention and the control groups.

Secondary ID(s)

531-31

Source(s) of Monetary Support

Fredrik och Ingrid Thurings Stiftelse, Sweden, Kalmar County Council

Secondary Sponsor(s)

Fredrik och Ingrid Thurings stiftelse

Ethics review

Status:
Approval date:
Contact:

The study was approved by the approved by the regional ethical review board of Linköping University, Faculty of Medicine, 13/02/2018, 2017/531-31

Results

• Results available: Yes
• Date Completed: 30/04/2021