Feasibility and Efficacy of Radically Open Dialectical Behavior Therapy for Youth At Risk for Developing Severe and Enduring Eating Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in eating disorder symptoms measured with Eating disorder Examination Questionnaire (EDE-Q)
研究概览
简要总结
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.
详细描述
BACKGROUND
Eating disorders are psychiatric disorders characterized by loss of control over food intake. Eating disorders impair function, have serious health implications, and are associated with high mortality. The mortality in anorexia nervosa is especially striking, as it is one of the psychiatric disorders with the highest mortality rates. Approximately 20% of patients with eating disorders develop long lasting illness, referred to as Severe and Enduring Eating Disorders (SEED). However, research on this group is scarce, and knowledge about treatment options is extremely limited.
Clinical factors related to poor outcome in anorexia, including SEED, are low age at onset, premorbid obsessive-compulsive personality traits, and autistic traits. Further, dysfunctional emotion regulation (ER) has been identified as a transdiagnostic psychological risk factor for many psychiatric disorders, including eating disorders. Dysfunctional ER can be characterized by traits of excessive self-control and emotional inhibition (overcontrol). Some propose that dysfunctional ER, characterized by emotional overcontrol, is a core aspect of restrictive eating disorders such as anorexia. Further, research suggests that loneliness relates to ER, with ER strategies like excessive self-control and emotional overcontrol in youths being associated to an increased sense of social isolation and lower life satisfaction later in life, increasing the risk for enduring mental health problems.
Despite this, few studies have evaluated the feasibility and effect of transdiagnostic interventions that specifically address emotional overcontrol in clinical trials, with the specific aim to evaluate if this might have the potential to change a chronic course. Radically open dialectical behavior therapy (RO-DBT) is a treatment which has been developed to target emotional overcontrol, hypothesized to be an underlying cause of the development and maintenance of anorexia and other restrictive eating disorders. In previous studies, the research group has found more pronounced emotional overcontrol in patients with anorexia compared to bulimia, that adult patients with anorexia responded to psychological treatment with RO-DBT targeting overcontrol, and that the patients appreciated this focus in therapy. Further, one previous study has evaluated RO-DBT for adolescents with eating disorders in an uncontrolled study with positive results. However, more research is needed.
The aim of this study is to evaluate feasibility and effect of the psychological treatment RO-DBT for adolescents with primarily restrictive eating disorder symptoms that have not responded to previous treatments and who therefore are at risk for developing SEED.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Change in eating disorder symptoms measured with Eating disorder Examination Questionnaire (EDE-Q)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- 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.)
- Change in social safeness and pleasure measured with the Social safeness and pleasure scale (SSPS)(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.)
- Changes in loneliness measured with the Loneliness scale(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.)
- Changes in loneliness measured with the UCLA Loneliness Scale(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.)
- Changes in symptoms of depression and anxiety measured with the Montgomery Åsberg Depression Scale Self-assessment (MADRS-S)(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.)
- Changes in maladaptive overcontrol during treatment, measured with weekly ratings.(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.)
研究者
Martina Isaksson
PhD, Licensed psychologist
Uppsala University Hospital