Evaluating the Efficacy of Radically Open Dialectical Behaviour Therapy (RO-DBT) in Patients With Anorexia Nervosa: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q
研究概览
简要总结
Randomized controlled clinical trial to evaluate the efficacy of "Radically Open Dialectical Behaviour Therapy" in patients with eating disorders: a proof-of-concept study.
详细描述
Background: Up to 20% of patients with anorexia nervosa (AN) die and 50% relapse after the first episode, being its treatment a great challenge for clinicians. Most therapies excessively focus excessively on nourishment, which translates to temporarily restored weight with no improvements in psychosocial life. Radically Open Dialectical Behaviour Therapy (RO-DBT) is a transdiagnostic treatment designed to treat overcontrol, a key aspect in the functioning of patients with AN. To date no clinical trial (CT) has proved its efficacy on these patients or has demonstrated its biological underpinning mechanisms.
Methods: A randomized CT in AN patients will be conducted, where one group will receive treatment as usual (TAU) and the other one TAU with plus RO-DBT, being psychosocial adjustment the main outcome; other secondary variables will be ED symptoms, overcontrol characteristics, autistic traits and neuroimaging changes.
Discussion: The results will fill the a knowledge gap in AN treatment, expecting that patients who receive TAU with RO-DBT will have better social adjustment and less relapses at one year follow up. This is the first study examining neuroimaging changes in RO-DBT to better understand its underlying mechanisms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female patients
- •aged between 18 to 65 years old,
- •having a diagnosis of AN (DSM 5 criteria),
- •having had weigh restoration treatment (normal BMI considered >19 kg/m2)
- •having an overcontrol personality style assessed with the styles of coping Word-Pair Checklist scale (ASC-WP)
排除标准
- •diagnosis of severe mental illness (schizophrenia or other psychosis, bipolar disorder, major depressive disorder, substance use disorder)
- •diagnosis of borderline personality disorder (BPD) or positive result in McLean Screening Instrument for BPD
- •mental retardation
- •being under standardized psychotherapy at the baseline
- •being illiterate or not able to understand Spanish language,
- •being left-handed
- •being pregnant for MRI requirements.
结局指标
主要结局
Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q
时间窗: 12 months
A self report questionarie that assesses quality of life. The range of scores is 0-100. Higher scores mean higher quality of life.
次要结局
- Clinical relapses(6 months, 12 months)
- Eating Disorder Inventory, EDI(6 months, 12 monghs)
- Social Connectedness Scale-Revised, SCS-R(6 months, 12 months)
- Assessed with the Questionnaire envy in adults, CEA(6 months, 12 months)
- Autism-Spectrum Quotient, AQ(6 months, 12 months)
- Rosenberg Self-Esteem Scale, RSE.(6 months, 12 months)
- Depression Anxiety and Stress Scale 21 (DASS-21)(6 months, 12 months)
- Inventory of Interpersonal Problems (IIP-64)(6 months, 12 months)
- Neuroimaging variables(6 months, 12 months)
- Clinical Outcomes in Routine Evaluation-Outcome Measure, CORE-OM,(6 months, 12 months)