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Completed

NCT Number: NCT04148014

Emotion Regulation Group Skills Training for Eating Disorders

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.

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Key information

Conditions

Eating Disorders Emotions Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Skill, Coping

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Region Ostergotland BUP-kliniken

Linköping, 581 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

An Adjunctive Emotion Regulation Skills Training

Behavioral

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 outcomes

  1. Difficulties with Emotion Regulation Scale (DERS)

    Time frame: 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)

    Time frame: 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).

    Time frame: 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)

    Time frame: 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 outcomes

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

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Region Östergötland

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 1, 2019
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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