Emotion Focused Internet Delivered Treatment for Adults with Eating Disorders

The goal of this clinical trial is to develop and test a new internet delivered treatment for adult patients with eating disorders, focused on developing normalized eating patterns and emotion regulation skills. The main focus is to investigate the additional effect of emotion regulation interventions, beyond the effect of other central tratment components normally included in evidence based eating disorder treatment.

The internet delivered treatment is divided into two phases, phase A and phase B. Phase A focus on establishing normalised eating patterns, and in phase B the emotion regulation interventions are added. Participants will get access to treatment modules every third day over a time period of 8.5 weeks, each module consist of psychopedagogical material, excercises and home work.

Data will be collected via the online research platform every third day during the treatment. Data is also collected at more comprehensive assessment points pre-treatment, post-treatment, and follow up 3 months after end of treatment.

Study Overview

• Status: Completed
• Conditions: Eating Disorders
• Intervention / Treatment: Behavioral: Emotion regulation treatment

Detailed Description

This study uses an experimental single-case design, specifically a randomized replicated AB design.

The baseline lenght (i.e., phase A) is randomized for each participant. There is six possible assignments, as the randomization is restricted to give all participants minimum 8 and maximum 12 treatment modules in each phase, with minimum 9 and maximum 14 baseline assessment points.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Östergötland
    • Linköping, Östergötland, Sweden, 58183
      • Linköping University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• DSM5 eating disorder
• Minimum 18 years old
• Ongoing contact with a psychiatric clinic in sweden

Exclusion Criteria:

• Body mass index below 18,5
• Somatic instability due to eating disorder severeness
• High risk of suicide or severe self-harm
• Ongoing addiction or substance abuse
• Ongoing psychological treatment or psychotherapy
• New or changed mediciation for psychiatric disorders in the past 2 months
• Planned or ongoing pregnancy or recently gave birth

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emotion regulation treatment	Behavioral: Emotion regulation treatment; Emotion regulation intervention in two phases. Phase A focus on establishing normalised eating patterns, and in phase B the emotion regulation interventions are added. Participants will get access to treatment modules every third day over a time period of 8.5 weeks, each module consist of psychopedagogical material, excercises and home work.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulties in Emotion Regulation Scale, 36 items	Assessment of emotion regulation difficulties. 36 items scored 1-5, higher scores indicate more difficulties. Total score range from 36-180.	At pre-treatment assessment one week before treatment start; at post-treatment assessment at day 63 counted from treatment start; and at follow-up assessment at day 153 counted from treatment start.
Difficulties in Emotion Regulation Scale, 16 items	Assessment of emotion regulation difficulties, short version. 16 items scored 1-5. Higher scores indicates more difficulties. Total score range from 16-80.	Counted from treatment start: at day 1, 4, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60
The Positive and Negative Affect Schedule, short form	Assessment of affect levels. In this study, only the subscale measuring negative affect is used. 5 items scored 1-5. Higher scores indicate higher levels of negative affect. Total score range from 5-25.	Counted from treatment start: at day 1, 4, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating Disorder Examination Questionnaire 6.0	Assessment of eating disorder symptoms. 28 items scored 0-6. Higher scores represent more eating disorder pathology. Scores are summerized and scaled, giving a total score ranging from 0-6.	At pre-treatment assessment one week before treatment start; at post-treatment assessment at day 63 counted from treatment start; and at follow-up assessment at day 153 counted from treatment start.
Eating Disorder Symptom List	Assessment of eating disorder symptoms. 8 items scored 0-3, with higher scores indicating more frequent eating disorder symptoms. Total score range from 0-24.	Counted from treatment start: at day 1, 4, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60
Clinical Impairment Assessment	Assessment of eating disorder related psychosocial impairment. 16 items scored 0-3. Higher scores indicate higher impairment. Total score range from 0-48.	At pre-treatment assessment one week before treatment start; at post-treatment assessment at day 63 counted from treatment start; and at follow-up assessment at day 153 counted from treatment start.
Clinical Impairment Assessment, subscale social	Assessment of eating disorder related psychosocial impairment, subscale focusing on social impariment. 5 items scored 0-3. Higher scores indicate higher impairment. Total score range from 0-15.	Counted from treatment start: at day 1, 4, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60
Normalized eating pattern	Self-assessment of eating patterns, developed by the authors for use in the present study. The self-assessment includes 2 questions: How many of the previous three days have you eaten regular meals approximately 6 times per day?; How many of the previous three days have you eaten normal sized portions at all or almost all meals? Items are scored 0-3. Higher scores indicare more normalized meal habits. Lower scores indicate disordered eating. Total score range from 0-6.	Counted from treatment start: at day 1, 4, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Hugo Hesser, PhD, Örebro University, Linköping University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Internet treatment; Eating disorder treatment; Emotion regulation treatment
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: IBL-2021-00215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data set analyzed during the present study is not publicly available, as it contains information that could compromise research participant privacy/consent. However, it could be made available on request to the corresponding author if granted by Swedish Ethical Review Authority.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No