Evaluation of Radically Open Dialectical Behavior Therapy for Youth At Risk for Developing Severe and Enduring Eating Disorders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-19
SponsorUppsala University Hospital

About this trial

The goal of this experimental interventional study is to learn if the psychological treatment Radically Open Dialectical Behavior Therapy (RO-DBT), is feasible to conduct and provide positive effects for adolescents with eating disorders and emotional overcontrol. Participants will be those at risk for developing severe and enduring eating disorder symptoms, as they have not responded fully to previous treatment attempts.

Primary outcomes are feasibility and changes in eating disorder symptoms. Secondary outcomes are changes in unhelpful behaviors and experiences related to emotional overcontrol; including psychological inflexibility, suppression of emotions, and experience of loneliness.

The participants will undergo the treatment with RO-DBT, which include an approximately 22 week long treatment consisting of individual psychotherapy and parallel skills training in group.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being 14-19 years old

Primarily restrictive eating disorder symptoms that remain despite at least one previous treatment attempt.

Problems related to maladaptive overcontrol

Written informed consent (for minors, this includes consent from all caregivers and the minors themselves).

Disqualifiers

Eating disorders symptoms in need of emergency care

High risk for suicide

An inability to respond to the questionnaires or participate in the skills class, e.g., due to lack of knowledge in Swedish.

Trial design

Design model

Single group

Treatments tested in this trial

  • Radically Open Dialectical Behavior Therapy (RO DBT)

    Behavioral

    The intervention is a psychological treatment using Radically Open Dialectical Behavior Therapy (RO-DBT), consisting of individual therapy and skills training in group for approximately 22 weeks. Additionally, a parent group consisting of four sessions will be included as an adaptation to the adolescent group.

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Exposure to Radically Open Dialectical Behavior Therapy (RO-DBT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in eating disorder symptoms measured with Eating disorder Examination Questionnaire (EDE-Q)

EDE-Q is a 28-item self-report questionnaire, designed to assess the range, frequency and severity of behaviors associated with an eating disorder. It is categorized into four sub-scales: Restraint, Eating Concern, Shape Concern and Weight Concern, and an overall global score. The score is obtained by calculating the mean for the total score and the subscales respectively (min = 0, max =6), higher scores indicate more severe eating disorder symptoms.

Time frame
At baseline measurement 1 (4-6 weeks before treatment initiation), at treatment completion (on average 24 weeks after treatment initiation), or immediately after the participant decides to end therapy prematurely, and 6 months after the end of treatment.
2

Change in eating disorder symptoms measured with Eating disorder symptom list (EDSL)

The EDSL is an eight-item self-rating questionnaire designed to assess eating disorder symptoms important for diagnosis. The scale is developed to detect change, or lack of change, during treatment. Participants are asked how many days during the preceding week they: restricted the amount of food, restricted the type of food, binged, vomited, used laxatives/diuretics, exercised excessively, experienced fear of gaining weight, or had thoughts about weight and shape that affected their self-image. Responses are given on an eight-point Likert scale ranging from 0 (no days) to 7 (seven days). Higher scores indicate greater difficulties

Time frame
Once each week during the baseline phase (4-6 weeks before the treatment is initiated), once each week during the treatment phase (approximately 24 weeks), and at one timepoint 6 months after the end of treatment.
3

Change in body mass index (BMI)

Weight and height will be combined to report BMI in kg/m\^2, assessed with a valid and reliable device in a standardized procedure. BMI is only an outcome for those with an underweight before study start, defined as 85% of expected body weight in relation to the participants age and gender.

Time frame
Once each week during the baseline phase (4-6 weeks before the treatment is initiated), once each week during the treatment phase (approximately 24 weeks), and at one timepoint 6 months after the end of treatment.
4

Feasibility - treatment credibility and expectancy

The Credibility/Expectancy Questionnaire (CEQ) is a psychological assessment tool designed to measure participants' expectations of treatment effects and their perceptions of the credibility of a psychological intervention. The CEQ helps researchers understand how expectations may influence treatment outcomes. The scale consists of six items, four of them are recorded using a nine-point Likert scale, ranging from 1 (not at all) to 9 (very much), higher scores indicate a greater credibility/expectation. The scale also contains two items asking for a percentage rating of how great improvement they think/feel will happen.

Time frame
At baseline measurement 1 (4-6 weeks before treatment initiation)

Secondary outcomes

1

Change in Eating disorder related functional impairment measured with the Clinical Impairment Assessment questionnaire (CIA)

The CIA is a 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features, Each item is rated on a four-point Likert scale ranging from 'Not at all' to 'A lot'. The minimun score is zero and the maximum score is 48, with higher scores indicating a more severe impairment.

Time frame
At baseline measurement 1 (4-6 weeks before treatment initiation), at treatment completion (on average 24 weeks after treatment initiation), or immediately after the participant decides to end therapy prematurely, and 6 months after the end of treatment.
2

Change in functional impairment measured with Uppsala scale of Functional Impairment in Daily life (UFID)

The UFID is a Five-item, five-point Likert scale that measures functional impairment in daily life on a score between 1-5. Higher scores indicate more functional impairment.

Time frame
At baseline measurement 1 (4-6 weeks before treatment initiation), at treatment completion (on average 24 weeks after treatment initiation), or immediately after the participant decides to end therapy prematurely, and 6 months after the end of treatment.
3

Change in self-perceived health measured with EQ-VAS

The EQ-VAS is a visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

Time frame
Once each week during the baseline phase (4-6 weeks before the treatment is initiated), once each week during the treatment phase (approximately 24 weeks), and at one timepoint 6 months after the end of treatment.
4

Change in maladaptive overcontrol, expressive suppression, measured with Emotion regulation questionnaire (ERQ)

The ERQ is a self-rating instrument designed to assess individual differences in the use of emotion regulation strategies. It is composed of ten items divided into two factors: cognitive reappraisal and expressive suppression. Participants indicate their answers on a 7-point Likert-scale ranging from 1 (total disagreement) to 7 (total agreement).

Time frame
At baseline measurement 1 (4-6 weeks before treatment initiation), at treatment completion (on average 24 weeks after treatment initiation), or immediately after the participant decides to end therapy prematurely, and 6 months after the end of treatment.

Other outcomes

1

The occurrence of Adverse events

Adverse events, primarily defined as worsening of mental health symptoms, weight loss, increased self-harming or suicidal behaviors, or any other unwanted experiences related to the intervention, will be assessed in a checklist by the individual therapist.

Time frame
Once each week during the baseline phase (4-6 weeks before the treatment is initiated), once each week during the treatment phase (approximately 24 weeks), and at one timepoint 6 months after the end of treatment.
2

Adherence to treatment protocol (ratings by therapists) assessed with the adherence form

Therapist adherence to the treatment protocol will be measured by therapist ratings for each session. The adherence form will contain a checklist of the session structure where the therapist is instructed to check the boxes of which parts were included, in addition to an own evaluation of treatment adherence, rated on a scale from 1 (=low adherence), 2 (=acceptable adherence), and 3 (=good adherence) A higher score indicate better adherence. The adherence form also include a space to write down the main theme/themes of the session content.

Time frame
Once each week during the treatment phase immediately after the individual therapy session (approximately 24 weeks).

Sponsors and contacts

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Uppsala University Hospital

Lead sponsor

Forskningsrådet för hälsa, arbetsliv och välfärd (FORTE)

Collaborator

The Söderströmska-Königska Foundation

Collaborator

Fonden för psykisk hälsa

Collaborator