Affect school as complementary treatment in eating disorders

ISRCTN ISRCTN11278582
DOI https://doi.org/10.1186/ISRCTN11278582
Secondary identifying numbers 531-31
Submission date
29/03/2018
Registration date
29/05/2018
Last edited
06/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Suzanne Petersson
Scientific

ABC, Kaggensgatan 42
Kalmar
s-392 32
Sweden

ORCiD logoORCID ID 0000-0002-4811-2090
Phone +46 480 84462
Email suzannep@ltkalmar.se

Study information

Study designA 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 designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleAffect school as complementary treatment in eating disorders: A randomized controlled study
Study objectivesBy 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(s)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
Health condition(s) or problem(s) studiedEating Disorders
InterventionBlock-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 typeOther
Primary outcome measure1.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 measures1. 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 study start date01/10/2017
Completion date30/04/2021

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsTwo arms with 25-30 patients in each arm. Target number for power is 21 patients in each arm.
Total final enrolment40
Key inclusion criteria1. Eating disorder diagnosis
2. Swedish as spoken language
3. Aged ≥18 years
Key exclusion criteria1. BMI <15 kg/m2
2. Acute state of starvation
3. Psychosis
4. Acute high level of suicidality
Date of first enrolment01/03/2018
Date of final enrolment30/04/2020

Locations

Countries of recruitment

  • Sweden

Study participating centre

AnorexiBulimiCenter
Kaggensgatan 42
Kalmar
S-39332
Sweden

Sponsor information

Regional Council in Kalmar County
Hospital/treatment centre

Division of Psychiatry
Box 601
Kalmar
S-391 26
Sweden

Website http://www.ltkalmar.se/
ROR logo "ROR" https://ror.org/01q8h4282
Fredrik och Ingrid Thurings stiftelse
Charity

c/o SEB
Private Banking, Stiftelser ST S3
Att: Maria Liljendahl
Stockholm
S-106 40 Stockholm
Sweden

Funders

Funder type

Not defined

Fredrik och Ingrid Thurings Stiftelse, Sweden

No information available

Kalmar County Council

No information available

Results and Publications

Intention to publish date31/03/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications interview study 17/02/2021 21/05/2021 Yes No
Basic results 17/05/2022 17/05/2022 No No
Results article 30/05/2022 22/08/2022 Yes No
Results article 28/07/2022 22/08/2022 Yes No
Protocol file 22/09/2022 06/10/2022 No No

Additional files

ISRCTN11278582_BasicResults_17May22.pdf
35055 protocol 22Sep2022.pdf

Editorial Notes

06/10/2022: Uploaded protocol (not peer-reviewed) as an additional file.
22/08/2022: Publication references added.
17/05/2022: The basic results of this trial have been uploaded as an additional file.
01/10/2021: IPD sharing statement added.
22/09/2021: The intention to publish date was changed from 31/10/2021 to 31/03/2022.
21/05/2021: Publication reference added.
12/05/2020: The total final enrolment number has been added.
16/01/2019: The following changes have been made to the trial record:
1. The recruitment end date has been changed from 01/10/2019 to 30/04/2020.
2. The overall trial end date has been changed from 31/12/2020 to 30/04/2021.
3. The intention to publish date has been changed from 01/11/2020 to 31/10/2021.