ACTRN12624000096550招募中Unknown
Stepped Care in the Treatment of Disordered Eating: A Randomised Controlled Pilot and Feasibility Study Comparing CBT-E to Guided-Self Help.
a Trobe University0 个研究点目标入组 100 人开始时间: 2024年2月2日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •* Age - 18 years or older
- •Disordered eating - Diagnosis of bulimia nervosa (BN), binge-eating disorder (BED), other-specified feeding or eating disorder (OSFED), unspecified feeding or eating disorder (UFED), based on EDE 17.0D assessment
- •Medical monitoring- Participant has a GP who is aware of participant’s disordered eating. Both participant and GP are willing to conduct medical monitoring during the trial. At a minimum, medical monitoring will include a medical assessment prior to study commencement, and at any point at which (i) the treating clinician deems it appropriate (e.g., where there are indicators of medical risk or instability) or (ii) the GP deems it necessary.Consent is provided by the participant for treating clinicians to share clinical information with their nominated GP and any other members of their treating team (e.g., dietician, psychiatrist) and for the GP to share clinical information with the treating clinician.
- •Suicide risk - No thoughts of suicide or self-harm, OR Irregular or fleeting thoughts of suicide or self-harm without intent or plan. Self-harm does not include binge eating, purging, laxative use or excessive exercise occurring as a symptom of disordered eating.
- •Medically StableBlood pressure, heart rate, Biochemistry including electrolytes indicate medical stability as assessed by the GP. No current rapid weight loss
- •Purging behaviour Low frequency. Fewer than 3 instances per day
- •Psychological riskNo comorbid severe mental health disorder (e.g., depression, anxiety symptoms in the severe to extremely severe range) OR Symptoms likely to interfere with engagement in treatment (e.g., active psychosis)
- •Recent hospital admissionNo eating disorder or other psychiatric (including self-harm) related hospital admission in previous 12 months.
- •Drug and alcoholNo drug and alcohol issues
- •BMIBMI >17.5kg/m2
- •Weight loss No significant rapid weight loss in previous 3 to 6 months
- •Structure/supervision required for eating/weight gainMust demonstrate some level of independent eating
- •Social and clinical supportsPresent (e.g., stable and safe housing, supportive family/friends/or living arrangements)
排除标准
- •* Age - under 18 years
- •* Disordered eating - Diagnosis of Anorexia nervosa (AN). No diagnosis of an eating disorder
- •* Medical monitoring - Participant does not want GP involved or unable to establish regular GP monitoring.
- •* Suicide risk - Regular thoughts or intent of suicide or self-harm, OR Current plan OR Previous attempts OR Serious and intentional self-harm
- •* Medically stable - Medically unstable i.e. Blood pressure, heart rate, electrolytes, cardiac function indicate medical instability or risk as assessed by the GP, OR Rapid weight loss (current), severe emaciation, OR Severe unstable medical comorbidity (e.g., unstable diabetes)
- •* Purging behaviour - Purging after every food/fluid intake or = than three instances per day. Haematemesis
- •* Psychological risk - Acute comorbid mental health disorder. Depression, Anxiety or Stress in Severe category (DASS21). Symptoms of psychosis
- •* Recent hospital admission - Long eating disorder or psychiatric (including self-harm) related admission history with minimal recovery OR Eating disorder or psychiatric (including self-harm) related hospital admission in previous 12 months.
- •* Drug and alcohol - Current active or untreated drug and alcohol use
- •* BMI - BMI less than 17.5kg/m2
- •* Weight loss - Experienced rapid weight loss across the past 3 to 6 months (e.g., a weight loss of more than 10-15% of total body mass in 3 – 6 months)
- •* Structure/supervision required for eating/weight gain - Supervision required at all meals
- •* Social and clinical supports - Not present
研究者
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