Emotion Focused Internet Delivered Treatment for Adults with Eating Disorders

NCT06885866 | Completed

• 1 other identifier: IBL-2021-00215
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eating Disorders

Keywords

Eating disorder treatment; Emotion regulation treatment; Internet treatment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Eating Disorder Examination Questionnaire 6.0

  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

  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

  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

  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

  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

Study Arms (1)

Emotion regulation treatment

EXPERIMENTAL

Behavioral: Emotion regulation treatment

Interventions

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.

Emotion regulation treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linköping University

Linköping, Östergötland County, 58183, Sweden

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Hugo Hesser, PhD

  Örebro University, Linköping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A single-case experimental randomized AB-design. Baseline length (i.e., phase A) and start of the B-phase is randomized for each participant. Both phases consist of active treatment, with the purpose of investigating if the interventions added in phase B could enhance treatment results additionally beyond the interventions given during the baseline period.

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 20, 2025
• Study Start: March 2, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)