Eating DisordersNCT04148014
Emotion Regulation Group Skills Training for Eating Disorders
A study testing An Adjunctive Emotion Regulation Skills Training in people with Eating Disorders and Emotions, run by Region Östergötland at 1 site in Sweden.
Trial summary
Emotion regulation difficulties appear to play a role in the development and maintenance of several eating disorders. This pilot study aims at examining whether a short add-on group skills training in emotion regulation for young adults with different eating disorders is feasible in a psychiatric clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Eating Disorders, Emotions, Skill, Coping
- What is being tested?
- An Adjunctive Emotion Regulation Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2017to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being enrolled as a patient at the eating disorder unit at eh child- and adolescent psychiatric clinic in Linköping, Sweden
- Having an eating disorder diagnosis as primary diagnosis.
- Being between the ages of 18-25 years
- Having sufficient knowledge of the Swedish language
Who cannot join
- Clinical diagnosis of schizophrenia
- Clinical diagnosis of psychosis
- Clinical diagnosis of severe autism spectrum disorder
- Having a cognitive disability
- Having ongoing drug or alcohol abuse
- Clinical diagnosis of bipolar disorder
- Insufficient knowledge of the Swedish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emotion Regulation Group Skills Training: A Pilot Study of an add-on Treatment for Eating Disorders in a Clinical Setting
Emotion regulation difficulties appear to play a role in the development and maintenance of several eating disorders. This pilot study aims at examining whether a short add-on group skills training in emotion regulation for young adults with different eating disorders is feasible in a psychiatric clinical setting. We also investigate if the treatment increases knowledge of emotions, and decreases self-reported difficulties with emotion regulation, alexithymia, symptoms of eating disorder, anxiety and depression, as well as clinical impairment.
Six skills training groups were piloted with a total of 29 participants (M = 21.41 years, SD = 1.92). The treatment consists of five sessions dealing with psychoeducation about emotions and emotion regulation skills training. Paired samples t-test was used to compare differences between before-and-after measures.
- Conditions
- Eating Disorders, Emotions, Skill, Coping
- Being tested
- An Adjunctive Emotion Regulation Skills Training
- Keywords
- eating disorders, young adults, emotion regulation skills
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An Adjunctive Emotion Regulation Skills TrainingBehavioural
The adjunctive emotion regulation skills training is delivered in a group format once a week during 5 weeks to young adults with eating disorders together with treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Adjunctive Emotion Regulation Skills Training | Experimental | Participants will receive a 5 session once a week group emotion regulation skills training adjacent to treatment as usual provided by the eating disorder unit at the child and adolescent psychiatric clinic, Linköping, Sweden. Receives: Behavioral: An Adjunctive Emotion Regulation Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties with Emotion Regulation Scale (DERS)
Difficulties with Emotion Regulation Scale measures difficulties with emotion regulation. It contains a total of 36 items that are rated on a Likert scale between 1-5. Total score ranges between 36-180 with higher scores indicating more difficulties with emotion regulation. The scale has 6 subscales: nonacceptance (ranging from 6-30); goals (ranging from 5-25); impulse (ranging from 6-30); awareness (ranging from 6-30); strategies (ranging from 8-40) and clarity (ranging from 5-25).
Measured: Change from baseline at 5 weeks
Toronto Alexithymia Scale (TAS-20)
Toronto Alexithymia Scale measures alexithymia. It contains a total of 20 items with 3 subscales (difficulties describing feelings: 7 items ranging from 7-35, difficulties identifying feelings: 5 items ranging from 5-25 and externally oriented thinking: 8 items ranging from 8-40). Total scores range from 20-100 with higher scores indicating higher levels of alexithymia.
Measured: Change from baseline at 5 weeks
Eating Disorder Examination Questionnaire (EDE-Q).
The Eating Disorder Examination Questionnaire (EDE-Q) is the self-report version of Eating Disorder Examination (EDE) and measures the characteristics of eating disorders. The 6.0 version used in this study consists of 28 items. EDE-Q is scored on a 7-point Likert scale, from "no days" to "every day" and higher scores indicate higher eating pathology. The total score ranges from 0-196. The questionnaire comprises a total scale and subscales for restraint, eating concerns, shape concerns and weight concerns.
Measured: Change from baseline at 5 weeks
The Clinical Impairment Assessment Questionnaire (CIA)
The Clinical Impairment Assessment Questionnaire (CIA) measures the psychosocial impairment of eating disorders. It focuses on the last 28 days and consists of 16 items, graded on a Likert scale from "Not at all" to "A lot". Higher scores indicate higher level of secondary psychosocial impairment and the total scores ranges from 0-48. The CIA is designed to be completed immediately after filling in a measure of current eating disorder features that covers the same time frame (e.g., the EDE-Q).
Measured: Change from baseline at 5 weeks
Secondary outcomes (2)
Montgomery Åsberg Depression Rating Scale, self-report version (MADRS-S).
Montgomery Åsberg Depression Rating Scale measures symptoms of depression. Its main purpose is to monitor the development of symptoms during treatment. The scale consists of 9 items, which are graded from zero to six. Total scores range from 0-54. Higher scores indicate higher level of depression symptoms.
Measured: Change from baseline at 5 weeks
Beck's Anxiety Inventory (BAI)
Beck's Anxiety Inventory measures symptoms of anxiety with 21 items rated on a four-graded scale (0-3). Total scores range from 0-63. Higher scores indicate higher levels of anxiety.
Measured: Change from baseline at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start1 Aug 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A pilot study without randomization or controlled design
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Zetterqvist, Region Östergötland
- Investigators
- Maria Zetterqvist, PhD, Principal investigator, Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148014
- Sponsor's protocol ID
- 2017/472-32
- Status last verified
- Oct 2019
- First submitted
- 30 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holmqvist Larsson K, Lowen A, Hellerstedt L, Bergcrona L, Salerud M, Zetterqvist M. Emotion regulation group skills training: a pilot study of an add-on treatment for eating disorders in a clinical setting. J Eat Disord. 2020 Apr 3;8:12. doi: 10.1186/s40337-020-00289-1. eCollection 2020.
PubMed 32266070
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation Group Skills Training: A Pilot Study of an add-on Treatment for Eating Disorders in a Clinical Setting
- ClinicalTrials.gov ID
- NCT04148014
- Acronym / sponsor ID
- 2017/472-32
- Conditions
- Eating Disorders, Emotions, Skill, Coping
- Keywords
- eating disorders, young adults, emotion regulation skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Emotion regulation difficulties appear to play a role in the development and maintenance of several eating disorders. This pilot study aims at examining whether a short add-on group skills training in emotion regulation for young adults with different eating disorders is feasible in a psychiatric clinical setting. We also investigate if the treatment increases knowledge of emotions, and decreases self-reported difficulties with emotion regulation, alexithymia, symptoms of eating disorder, anxiety and depression, as well as clinical impairment.
Six skills training groups were piloted with a total of 29 participants (M = 21.41 years, SD = 1.92). The treatment consists of five sessions dealing with psychoeducation about emotions and emotion regulation skills training. Paired samples t-test was used to compare differences between before-and-after measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A pilot study without randomization or controlled design
| Arm | Type | Receives |
|---|---|---|
| Adjunctive Emotion Regulation Skills Training | Experimental | Behavioral: An Adjunctive Emotion Regulation Skills TrainingParticipants will receive a 5 session once a week group emotion regulation skills training adjacent to treatment as usual provided by the eating disorder unit at the child and adolescent psychiatric clinic, Linköping, Sweden. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being enrolled as a patient at the eating disorder unit at eh child- and adolescent psychiatric clinic in Linköping, Sweden
- Having an eating disorder diagnosis as primary diagnosis.
- Being between the ages of 18-25 years
- Having sufficient knowledge of the Swedish language
Key exclusion criteria (7 listed)
- Clinical diagnosis of schizophrenia
- Clinical diagnosis of psychosis
- Clinical diagnosis of severe autism spectrum disorder
- Having a cognitive disability
- Having ongoing drug or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An Adjunctive Emotion Regulation Skills TrainingThe adjunctive emotion regulation skills training is delivered in a group format once a week during 5 weeks to young adults with eating disorders together with treatment as usual | Behavioural | Adjunctive Emotion Regulation Skills Training |
Primary outcome
Difficulties with Emotion Regulation Scale (DERS)
Time frame: Change from baseline at 5 weeks
Difficulties with Emotion Regulation Scale measures difficulties with emotion regulation. It contains a total of 36 items that are rated on a Likert scale between 1-5. Total score ranges between 36-180 with higher scores indicating more difficulties with emotion regulation. The scale has 6 subscales: nonacceptance (ranging from 6-30); goals (ranging from 5-25); impulse (ranging from 6-30); awareness (ranging from 6-30); strategies (ranging from 8-40) and clarity (ranging from 5-25).
Toronto Alexithymia Scale (TAS-20)
Time frame: Change from baseline at 5 weeks
Toronto Alexithymia Scale measures alexithymia. It contains a total of 20 items with 3 subscales (difficulties describing feelings: 7 items ranging from 7-35, difficulties identifying feelings: 5 items ranging from 5-25 and externally oriented thinking: 8 items ranging from 8-40). Total scores range from 20-100 with higher scores indicating higher levels of alexithymia.
Eating Disorder Examination Questionnaire (EDE-Q).
Time frame: Change from baseline at 5 weeks
The Eating Disorder Examination Questionnaire (EDE-Q) is the self-report version of Eating Disorder Examination (EDE) and measures the characteristics of eating disorders. The 6.0 version used in this study consists of 28 items. EDE-Q is scored on a 7-point Likert scale, from "no days" to "every day" and higher scores indicate higher eating pathology. The total score ranges from 0-196. The questionnaire comprises a total scale and subscales for restraint, eating concerns, shape concerns and weight concerns.
The Clinical Impairment Assessment Questionnaire (CIA)
Time frame: Change from baseline at 5 weeks
The Clinical Impairment Assessment Questionnaire (CIA) measures the psychosocial impairment of eating disorders. It focuses on the last 28 days and consists of 16 items, graded on a Likert scale from "Not at all" to "A lot". Higher scores indicate higher level of secondary psychosocial impairment and the total scores ranges from 0-48. The CIA is designed to be completed immediately after filling in a measure of current eating disorder features that covers the same time frame (e.g., the EDE-Q).
2 secondary outcomes
Montgomery Åsberg Depression Rating Scale, self-report version (MADRS-S).
Time frame: Change from baseline at 5 weeks
Beck's Anxiety Inventory (BAI)
Time frame: Change from baseline at 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Derived from this study: PubMed 32266070Holmqvist Larsson K, Lowen A, Hellerstedt L, Bergcrona L, Salerud M, Zetterqvist M. Emotion regulation group skills training: a pilot study of an add-on treatment for eating disorders in a clinical setting. J Eat Disord. 2020 Apr 3;8:12. doi: 10.1186/s40337-020-00289-1. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Zetterqvist, PhD principal investigator
Region Östergötland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An Adjunctive Emotion Regulation Skills Training in people with Eating Disorders and Emotions, run by Region Östergötland at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties with Emotion Regulation Scale (DERS) (time frame: Change from baseline at 5 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04148014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.