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Emotion Regulation Group Skills Training for Eating Disorders

Primary Purpose

Eating Disorders, Emotions, Skill, Coping

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
An Adjunctive Emotion Regulation Skills Training
Sponsored by
Region Östergötland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring eating disorders, young adults, emotion regulation skills

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Region Ostergotland BUP-kliniken

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adjunctive Emotion Regulation Skills Training

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
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.
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.
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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 30, 2019
Last Updated
October 31, 2019
Sponsor
Region Östergötland
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1. Study Identification

Unique Protocol Identification Number
NCT04148014
Brief Title
Emotion Regulation Group Skills Training for Eating Disorders
Official Title
Emotion Regulation Group Skills Training: A Pilot Study of an add-on Treatment for Eating Disorders in a Clinical Setting
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Östergötland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Emotions, Skill, Coping
Keywords
eating disorders, young adults, emotion regulation skills

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A pilot study without randomization or controlled design
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adjunctive Emotion Regulation Skills Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
An Adjunctive Emotion Regulation Skills Training
Intervention Description
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
Primary Outcome Measure Information:
Title
Difficulties with Emotion Regulation Scale (DERS)
Description
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).
Time Frame
Change from baseline at 5 weeks
Title
Toronto Alexithymia Scale (TAS-20)
Description
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.
Time Frame
Change from baseline at 5 weeks
Title
Eating Disorder Examination Questionnaire (EDE-Q).
Description
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.
Time Frame
Change from baseline at 5 weeks
Title
The Clinical Impairment Assessment Questionnaire (CIA)
Description
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).
Time Frame
Change from baseline at 5 weeks
Secondary Outcome Measure Information:
Title
Montgomery Åsberg Depression Rating Scale, self-report version (MADRS-S).
Description
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.
Time Frame
Change from baseline at 5 weeks
Title
Beck's Anxiety Inventory (BAI)
Description
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.
Time Frame
Change from baseline at 5 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Participant eligibility is based on biological sex.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Zetterqvist, PhD
Organizational Affiliation
Region Östergötland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Ostergotland BUP-kliniken
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32266070
Citation
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.
Results Reference
derived

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Emotion Regulation Group Skills Training for Eating Disorders

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