NCT04148014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

1.7 years

First QC Date

October 30, 2019

Last Update Submit

October 31, 2019

Conditions

Keywords

eating disordersyoung adultsemotion regulation skills

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Montgomery Åsberg Depression Rating Scale, self-report version (MADRS-S).

    Change from baseline at 5 weeks

  • Beck's Anxiety Inventory (BAI)

    Change from baseline at 5 weeks

Study Arms (1)

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.

Behavioral: An Adjunctive Emotion Regulation Skills Training

Interventions

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

Adjunctive Emotion Regulation Skills Training

Eligibility Criteria

Age18 Years - 25 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParticipant eligibility is based on biological sex.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Ostergotland BUP-kliniken

Linköping, 581 85, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Maria Zetterqvist, PhD

    Region Östergötland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A pilot study without randomization or controlled design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal investigator

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 1, 2019

Study Start

August 1, 2017

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

November 1, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations