Emotion Focused Internet Delivered Treatment for Adults with Eating Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Difficulties in Emotion Regulation Scale, 36 items
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Emotion regulation treatment
Intervention: Emotion regulation treatment (Behavioral)
Outcomes
Primary Outcomes
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.
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.
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
- 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)
Investigators
Hugo Hesser
Professor
Linkoeping University