- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04148014
Emotion Regulation Group Skills Training for Eating Disorders
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Linköping, Sweden, 581 85
- Region Östergötland BUP-kliniken
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Adjunctive Emotion Regulation Skills Training
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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difficulties with Emotion Regulation Scale (DERS)
Time Frame: Change from baseline at 5 weeks
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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).
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Change from baseline at 5 weeks
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Toronto Alexithymia Scale (TAS-20)
Time Frame: Change from baseline at 5 weeks
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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.
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Change from baseline at 5 weeks
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Eating Disorder Examination Questionnaire (EDE-Q).
Time Frame: Change from baseline at 5 weeks
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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.
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Change from baseline at 5 weeks
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The Clinical Impairment Assessment Questionnaire (CIA)
Time Frame: Change from baseline at 5 weeks
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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).
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Change from baseline at 5 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montgomery Åsberg Depression Rating Scale, self-report version (MADRS-S).
Time Frame: Change from baseline at 5 weeks
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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.
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Change from baseline at 5 weeks
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Beck's Anxiety Inventory (BAI)
Time Frame: Change from baseline at 5 weeks
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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.
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Change from baseline at 5 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria Zetterqvist, PhD, Region Östergötland
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/472-32
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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