Plain English Summary
Background and study aims
Eating disorders are relatively common, serious psychiatric disorders that cause significant suffering for persons with eating disorders and their families and friends. Eating disorder diagnoses include anorexia nervosa (AN), bulimia nervosa (BN), and related eating disorders. The condition is considered hard to treat. Persons with an eating disorder inhibit or repress emotions, have a poorer emotional awareness, and tend to have larger problems coping with emotions compared to healthy persons. This is a problem when working towards recovery.
This study aims to evaluate the effect of adding Affect school treatment to regular eating disorder treatment at an outpatient clinic.With this intervention we aim to enhance emotional awareness and coping and therefore reach better results in the treatment of eating disorders.
Who can participate?
Patients at the AnorexiBulimiCenter (ABC) will be asked to participate in this study. The ABC is a public, youth/adult, integrated psychiatric outpatient clinic situated in southern Sweden. Patients with all kinds of eating disorders are treated at the clinic. Participants will be between 18-60 years old. Most of the patients are female (about 2% are men), but all patients at the clinic who has an eating disorder diagnosis, speaks Swedish, has a Body Mass Index over 15, who is not suicidal or having an ongoing psychosis, and who is not in an acute starvation will be asked to participate in the study.
What does the study involve?
Participants will be randomly allocated into two groups; an Affect school group and a control group. Participants in both groups will continue their regular treatment at the clinic (for example psychotherapy, physiotherapy, day care). Participation is voluntary and the evaluation of the intervention will be performed using self-assessment scales on eating disorder symptoms and emotion coping, together with eating disorder diagnoses before and twelve months after the intervention. Some of the patients (randomly chosen) will participate in an interview about the Affect school after their participation in the group treatment.
The Affect school is an eight session group treatment that covers basic emotions like joy, anger, interest, fear, disgust, dissmell and shame. The weekly sessions last for two hours and contain education on emotions together with manual based group discussions.
What are the possible benefits and risks of participating?
There will be no benefit to those who are drawn to the control group. We think there will be benefits for participants in the intervention group since the intervention may enhance participants emotional awareness which is expected to enhance the results of their regular treatment as well. We also think that sharing experiences with other patients is beneficial. Regarding risks for impairment of participants’ psychiatric condition, the staff at the clinic is well educated and experienced and performs regular evaluations of the patients (including the participants). There is a risk that by attending in the project the participants will feel that it is a waste of their time or that they will experience the meetings negatively. There is also a risk that participants in the control group will be disappointed when they do not get the possibility to attend the Affect school.
Where is the study run from?
ABC clinic, Kalmar County Council (Sweden)
When is the study starting and how long is it expected to run for?
October 2017 to December 2020.
Who is funding the study?
1.Division of Psychiatry, Kalmar County Council (Sweden)
2.Fredrik och Ingrid Thurings Stiftelse (Sweden)
Who is the main contact?
Dr Suzanne Petersson
suzannep@ltkalmar.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Suzanne Petersson
ORCID ID
http://orcid.org/0000-0002-4811-2090
Contact details
ABC
Kaggensgatan 42
Kalmar
s-392 32
Sweden
+46 480 84462
suzannep@ltkalmar.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
531-31
Study information
Scientific title
Affect school as complementary treatment in eating disorders:
A randomized controlled study
Acronym
Study hypothesis
By adding an 8-week manual based Affect school intervention to the usual eating disorder treatment, patients are expected to be more aware of how to manage emotions and thus reduce their eating disorder symptoms (measured with Eating Disorder Examination Questionnaire, Toronto Alexythymia Scale-20, Deficits in Emotion Regulation Scale, and Body Mass Index).
Ethics approval
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
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Eating Disorders
Intervention
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.
Intervention type
Other
Phase
Drug names
Primary outcome measure
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 measures
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.
Overall trial start date
01/10/2017
Overall trial end date
31/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Eating disorder diagnosis
2. Swedish as spoken language
3. Aged ≥18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Two arms with 25-30 patients in each arm. Target number for power is 21 patients in each arm.
Participant exclusion criteria
1. BMI <15 kg/m2
2. Acute state of starvation
3. Psychosis
4. Acute high level of suicidality
Recruitment start date
01/03/2018
Recruitment end date
01/10/2019
Locations
Countries of recruitment
Sweden
Trial participating centre
AnorexiBulimiCenter
Kaggensgatan 42
Kalmar
S-39332
Sweden
Sponsor information
Organisation
Division of Psychiatry, Kalmar County Council
Sponsor details
Box 601
Kalmar
S-391 26
Sweden
Sponsor type
Hospital/treatment centre
Website
Organisation
Fredrik och Ingrid Thurings stiftelse
Sponsor details
c/o SEB
Private Banking
Stiftelser ST S3
Att: Maria Liljendahl
Stockholm
S-106 40 Stockholm
Sweden
Sponsor type
Charity
Website
Funders
Funder type
Not defined
Funder name
Fredrik och Ingrid Thurings Stiftelse, Sweden
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Kalmar County Council
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal
Intention to publish date
01/11/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list