Condition category
Mental and Behavioural Disorders
Date applied
29/03/2018
Date assigned
29/05/2018
Last edited
29/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes