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
Verified date | October 2019 |
Source | Region Östergötland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Region Ostergotland BUP-kliniken | Linköping |
Lead Sponsor | Collaborator |
---|---|
Region Östergötland |
Sweden,
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 |
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