Emotion Regulation Group Skills Training for Eating Disorders

Eating Disorders Clinical Trial

Official title:

Emotion Regulation Group Skills Training: A Pilot Study of an add-on Treatment for Eating Disorders in a Clinical Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04148014
• Other study ID #: 2017/472-32
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: October 2019
• Source: Region Östergötland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Eating Disorders
• Emotions
• Feeding and Eating Disorders
• Skill, Coping

Intervention

Behavioral:
• An Adjunctive Emotion Regulation Skills Training
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

Locations

Country	Name	City	State
Sweden	Region Ostergotland BUP-kliniken	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Region Östergötland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline at 5 weeks
Primary	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.	Change from baseline at 5 weeks
Primary	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.	Change from baseline at 5 weeks
Primary	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).	Change from baseline at 5 weeks
Secondary	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.	Change from baseline at 5 weeks
Secondary	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.	Change from baseline at 5 weeks