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

Condition(s) studied

Investigational drug(s) / intervention(s)

Radically Open Dialectical Behavior Therapy (RO DBT): 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.

Study summary

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

Primary outcome measure(s)

• Change in eating disorder symptoms measured with Eating disorder Examination Questionnaire (EDE-Q) — 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.
  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.
• Change in eating disorder symptoms measured with Eating disorder symptom list (EDSL) — 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.
  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
• Change in body mass index (BMI) — 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.
  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.
• Feasibility - treatment credibility and expectancy — At baseline measurement 1 (4-6 weeks before treatment initiation)
  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.
• Feasibility - acceptability — Within 1 month after treatment completion (on average 26 weeks after treatment initiation), or within 1 month after the participant decides to end therapy prematurely.
  Acceptability will be assessed via a qualitative interview where participants are asked to share their experiences of the treatment.
• Feasibility - inclusion rates — Before first baseline, during recruitment (typically within one month before enrollment)
  Inclusion rates will be assessed by contrasting the number of participants who show interest and are evaluated for participation to the number of participant actually enrolled.
• Feasibility - drop-out rates — At treatment completion (on average 24 weeks after treatment initiation), or immediately after the participant decides to end therapy prematurely.
  Drop-out rates will be assessed by contrasting the number of individuals who completed the treatment as planned and recommended with the number of those who dropped out prematurely, either by their own choice or due to adverse events that prevented completion.
• Feasibility - Completion of homework — Once each week during the treatment phase immediately after the individual therapy session (approximately 24 weeks).
  Completion of homework will be assessed by the individual therapist rating the level of completed homework on a 3-item Likert scale: 1 (not at all completed), 2 (partially completed), and 3 (completed).
• Feasibility - attendance to sessions — Once each week during the treatment phase immediately after the individual therapy session (approximately 24 weeks).
  Attendance to sessions will be calculated by contrasting the number of completed individual therapy sessions and skills sessions respectively with the expected number of completed individual therapy sessions (22-24) and skills sessions (20).

Trial sites (1)

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