Skip to main content
OpenTrials
Completed

NCT Number: NCT06885866

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Eating Disorders Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping University

Linköping, Östergötland County, 58183, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Emotion regulation treatment

Behavioral

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.

Primary outcomes

  1. Difficulties in Emotion Regulation Scale, 36 items

    Time frame: 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.

    Assessment of emotion regulation difficulties. 36 items scored 1-5, higher scores indicate more difficulties. Total score range from 36-180.

  2. Difficulties in Emotion Regulation Scale, 16 items

    Time frame: 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

    Assessment of emotion regulation difficulties, short version. 16 items scored 1-5. Higher scores indicates more difficulties. Total score range from 16-80.

  3. The Positive and Negative Affect Schedule, short form

    Time frame: 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

    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.

Secondary outcomes

  1. Eating Disorder Examination Questionnaire 6.0

    Time frame: 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.

    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.

  2. Eating Disorder Symptom List

    Time frame: 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

    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.

  3. Clinical Impairment Assessment

    Time frame: 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.

    Assessment of eating disorder related psychosocial impairment. 16 items scored 0-3. Higher scores indicate higher impairment. Total score range from 0-48.

  4. Clinical Impairment Assessment, subscale social

    Time frame: 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

    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.

  5. Normalized eating pattern

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.