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

NCT06792071 | Recruiting

• 1 other identifier: RO-SEED
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eating Disorders; Anorexia Nervosa; Anorexia Nervosa, Atypical; Feeding and Eating Disorders

Keywords

Anorexia Nervosa; Eating disorders; Radically open dialectical behavior therapy; Single-case experimental design study

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

• 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

  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.

• 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.

  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.

• 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.

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

• Feasibility - acceptability

  Acceptability will be assessed via a qualitative interview where participants are asked to share their experiences of the treatment.

  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.

• Feasibility - inclusion rates

  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.

  Before first baseline, during recruitment (typically within one month before enrollment)

• Feasibility - drop-out rates

  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.

  At treatment completion (on average 24 weeks after treatment initiation), or immediately after the participant decides to end therapy prematurely.

• Feasibility - Completion of homework

  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).

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

• Feasibility - attendance to sessions

  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).

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

Secondary Outcomes (10)

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

  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.

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

  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.

• Change in self-perceived health measured with EQ-VAS

  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.

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

  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.

• Change in maladaptive overcontrol, psychological inflexibility, is measured with The Avoidance and Fusion Questionnaire for Youth (AFQ-Y)

  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 (2)

• The occurrence of Adverse events

  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.

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

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

Study Arms (1)

Exposure to Radically Open Dialectical Behavior Therapy (RO-DBT)

EXPERIMENTAL

Behavioral: Radically Open Dialectical Behavior Therapy (RO DBT)

Interventions

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.

Exposure to Radically Open Dialectical Behavior Therapy (RO-DBT)

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Forskningsrådet för hälsa, arbetsliv och välfärd (FORTE): collaborator
• The Söderströmska-Königska Foundation: collaborator
• Fonden för psykisk hälsa: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

RECRUITING

Related Publications (11)

• Kratochwill, T. R., Hitchcock, J., Horner, R. H., Levin, J. R., Odom, S. L., Rindskopf, D. M., & Shadish, W. R. (2013). Single-case intervention research design standards. Remedial and Special Education, 34(1), 26-38. https://doi.org/10.1177/0741932512452794

  BACKGROUND

• Baudinet J, Simic M, Griffiths H, Donnelly C, Stewart C, Goddard E. Targeting maladaptive overcontrol with radically open dialectical behaviour therapy in a day programme for adolescents with restrictive eating disorders: an uncontrolled case series. J Eat Disord. 2020 Nov 13;8(1):68. doi: 10.1186/s40337-020-00338-9.

  PMID: 33292696 BACKGROUND

• Lynch, T. R. (2018). Radically open dialectical behavior therapy: Theory and practice for treating disorders of overcontrol. New Harbinger Publications

  BACKGROUND

• Isaksson M, Ghaderi A, Wolf-Arehult M, Oster C, Ramklint M. Sharing and connecting with others - patient experiences of radically open dialectical behavior therapy for anorexia nervosa and overcontrol: a qualitative study. J Eat Disord. 2021 Mar 4;9(1):29. doi: 10.1186/s40337-021-00382-z.

  PMID: 33663612 BACKGROUND

• Isaksson M, Ghaderi A, Ramklint M, Wolf-Arehult M. Radically open dialectical behavior therapy for anorexia nervosa: A multiple baseline single-case experimental design study across 13 cases. J Behav Ther Exp Psychiatry. 2021 Jun;71:101637. doi: 10.1016/j.jbtep.2021.101637. Epub 2021 Jan 12.

  PMID: 33524917 BACKGROUND

• Isaksson M, Ghaderi A, Wolf-Arehult M, Ramklint M. Overcontrolled, undercontrolled, and resilient personality styles among patients with eating disorders. J Eat Disord. 2021 Apr 16;9(1):47. doi: 10.1186/s40337-021-00400-0.

  PMID: 33863394 BACKGROUND

• Oldershaw A, Lavender T, Sallis H, Stahl D, Schmidt U. Emotion generation and regulation in anorexia nervosa: a systematic review and meta-analysis of self-report data. Clin Psychol Rev. 2015 Jul;39:83-95. doi: 10.1016/j.cpr.2015.04.005. Epub 2015 May 2.

  PMID: 26043394 BACKGROUND

• Prefit AB, Candea DM, Szentagotai-Tatar A. Emotion regulation across eating pathology: A meta-analysis. Appetite. 2019 Dec 1;143:104438. doi: 10.1016/j.appet.2019.104438. Epub 2019 Aug 31.

  PMID: 31479694 BACKGROUND

• Wentz E, Gillberg IC, Anckarsater H, Gillberg C, Rastam M. Adolescent-onset anorexia nervosa: 18-year outcome. Br J Psychiatry. 2009 Feb;194(2):168-74. doi: 10.1192/bjp.bp.107.048686.

  PMID: 19182181 BACKGROUND

• Keel PK, Brown TA. Update on course and outcome in eating disorders. Int J Eat Disord. 2010 Apr;43(3):195-204. doi: 10.1002/eat.20810.

  PMID: 20186717 BACKGROUND

• Treasure J, Duarte TA, Schmidt U. Eating disorders. Lancet. 2020 Mar 14;395(10227):899-911. doi: 10.1016/S0140-6736(20)30059-3.

  PMID: 32171414 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Martina Isaksson, PhD

CONTACT

+46706954108; martina.isaksson@uu.se

Mia Ramklint, PhD

CONTACT

+46730949181; mia.ramklint@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinded randomization of baseline length is performed in blocks of three (4, 5, or 6 weeks) by a researcher or research assistant not otherwise involved with the participants.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Licensed psychologist

Model Details: Single case experimental design study with multiple baselines. Thus, each individual is their own control.

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 24, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)