Affect school as complementary treatment in eating disorders
| ISRCTN | ISRCTN11278582 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11278582 |
| Protocol serial number | 531-31 |
| Sponsors | Regional Council in Kalmar County, Fredrik och Ingrid Thurings stiftelse |
| Funders | Fredrik och Ingrid Thurings Stiftelse, Sweden, Kalmar County Council |
- 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
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
Scientific
ABC, Kaggensgatan 42
Kalmar
s-392 32
Sweden
 ORCID ID |
0000-0002-4811-2090 |
|---|---|
| Phone | +46 480 84462 |
| suzannep@ltkalmar.se |
Study information
| Primary study design | 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. |
| Secondary study design | Randomised controlled trial |
| Scientific title | Affect school as complementary treatment in eating disorders: A randomized controlled study |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(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. |
| Key secondary outcome measure(s) |
1. Body Mass Index (BMI) at the start of the intervention and after 12 months. |
| Completion date | 30/04/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Eating disorder diagnosis 2. Swedish as spoken language 3. Aged ≥18 years |
| Key exclusion criteria | 1. BMI <15 kg/m2 2. Acute state of starvation 3. Psychosis 4. Acute high level of suicidality |
| Date of first enrolment | 01/03/2018 |
| Date of final enrolment | 30/04/2020 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Kalmar
S-39332
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The 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? |
|---|---|---|---|---|---|
| Results article | 30/05/2022 | 22/08/2022 | Yes | No | |
| Results article | 28/07/2022 | 22/08/2022 | Yes | No | |
| Basic results | 17/05/2022 | 17/05/2022 | No | No | |
| Other publications | interview study | 17/02/2021 | 21/05/2021 | Yes | No |
| Protocol file | 22/09/2022 | 06/10/2022 | No | No |
Additional files
- ISRCTN11278582_BasicResults_17May22.pdf
- Basic results
- 35055 protocol 22Sep2022.pdf
- Protocol file
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.
