Clinical trial NCT06885866: Emotion Focused Internet Delivered Treatment for Adults with Eating Disorders
Official title: Emotion Focused Internet Delivered Treatment for Adults with Eating Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Keywords: Eating disorder treatment
Emotion regulation treatment
Internet treatment
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2025-03-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difficulties in Emotion Regulation Scale, 36 items
timeFrame: 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.
measure: Difficulties in Emotion Regulation Scale, 16 items
timeFrame: 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
measure: The Positive and Negative Affect Schedule, short form
timeFrame: 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:
measure: Eating Disorder Examination Questionnaire 6.0
timeFrame: 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.
measure: Eating Disorder Symptom List
timeFrame: 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
measure: Clinical Impairment Assessment
timeFrame: 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.
measure: Clinical Impairment Assessment, subscale social
timeFrame: 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
measure: Normalized eating pattern
timeFrame: 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
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
state: Östergötland
Study officials:
affiliation: Örebro University, Linköping University
name: Hugo Hesser, PhD
role: PRINCIPAL_INVESTIGATOR
References: