Emotion Regulation Group Skills Training for Eating Disorders

Sponsor
Region Östergötland (Other)
Overall Status
Completed
CT.gov ID
NCT04148014
Collaborator
(none)
39
1
1
20.9
1.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: An Adjunctive Emotion Regulation Skills Training
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A pilot study without randomization or controlled designA pilot study without randomization or controlled design
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Emotion Regulation Group Skills Training: A Pilot Study of an add-on Treatment for Eating Disorders in a Clinical Setting
Actual Study Start Date :
Aug 1, 2017
Actual Primary Completion Date :
Apr 30, 2019
Actual Study Completion Date :
Apr 30, 2019

Arms and Interventions

Arm Intervention/Treatment
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.

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

Outcome Measures

Primary Outcome Measures

  1. Difficulties with Emotion Regulation Scale (DERS) [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).

  2. Toronto Alexithymia Scale (TAS-20) [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.

  3. Eating Disorder Examination Questionnaire (EDE-Q). [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.

  4. The Clinical Impairment Assessment Questionnaire (CIA) [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).

Secondary Outcome Measures

  1. Montgomery Åsberg Depression Rating Scale, self-report version (MADRS-S). [Change from baseline at 5 weeks]

    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.

  2. Beck's Anxiety Inventory (BAI) [Change from baseline at 5 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Region Ostergotland BUP-kliniken Linköping Sweden 581 85

Sponsors and Collaborators

  • Region Östergötland

Investigators

  • Principal Investigator: Maria Zetterqvist, PhD, Region Ostergotland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria Zetterqvist, Prinicipal investigator, Region Östergötland
ClinicalTrials.gov Identifier:
NCT04148014
Other Study ID Numbers:
  • 2017/472-32
First Posted:
Nov 1, 2019
Last Update Posted:
Nov 1, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maria Zetterqvist, Prinicipal investigator, Region Östergötland
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2019