Individual Schema-mode Therapy for Anorexia Nervosa: a Pilot Case Series
试验速览
- 阶段
- 不适用
- 发起方
- NHS Lothian
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Eating Disorders Examination questionnaire (EDE-Q)
研究概览
简要总结
A reliably effective treatment model for anorexia nervosa is yet to emerge. Recent clinical trials of psychological therapies over 20-30 sessions, have shown modest benefits. There is therefore a need to test new treatments to find more effective treatments. Clinical trials of Schema Therapy have shown low rates of dropout, which is often a problem in the treatment of anorexia nervosa. Treatment with Schema Therapy, for significantly longer than 20-30 sessions, has been shown to be effective for other complex mental health problems.This pilot study is therefore designed to pilot the use of individual Schema Therapy for people with Anorexia Nervosa (iST-AN). This study is a case series pilot study. The study will answer the principal research question: Does individual Schema mode Therapy, adapted for eating disorders, have the potential to improve symptoms, quality of life and weight in people with moderate-severe anorexia nervosa? It will also address secondary research questions: Can people with moderate-severe anorexia nervosa be recruited to, and kept engaged in, a study of iST-AN treatment? What is the ideal length of iST-AN treatment? What is the relationship between self-criticism, body shame, or unhelpful psychological 'modes' and clinical outcome? Fifteen people with moderate-severe Anorexia Nervosa will be recruited from referrals to a specialist eating disorders outpatient service. The study will deliver 65 sessions of Schema Therapy for anorexia nervosa (iST-AN), over a 24 month period, alongside any additional medical or dietetic management required. Standard outcome measures will be collected at 6 month intervals. The research team have expertise in eating disorders research, schema therapy for severe anorexia nervosa and are all members of the local clinical service. The study will take place over a 3 year period.
详细描述
Aims & Hypotheses
The aims of this pilot case series of individual Schema-mode Therapy for Anorexia Nervosa (iST-AN) are:
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To test the potential efficacy of iST-AN treatment, including
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exploring optimal length of treatment
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refining the iST-AN treatment manual
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To test recruitment and retention in iST-AN treatment
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To explore hypotheses relating to self-criticism, body shame & change in strength of modes.
We anticipate that treatment with iST-AN will result in adequate recruitment and a high level of retention in treatment. We hypothesise that treatment with iST-AN will result in significant change in eating disorder symptoms, quality of life (QoL) and body mass index (BMI). We hypothesise that improved symptoms, QoL and BMI will correlate with reduced self-criticism, reduced body shame and reduced strength of maladaptive coping modes.
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
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AN or other DSM-V underweight eating disorder diagnosis AND
- •18 yrs or over AND
- •Moderate-severe, treatment resistant, comorbid, or chronic 3.
- •BMI 13-15 OR 3.
- •BMI 15-17.5 and ≥ 1 previous treatment episode for eating disorder OR 3.
- •BMI 15-17.5 and a personality disorder diagnosis OR 3.
- •BMI 15-17.5 and duration of eating disorder of > 10 yrs
排除标准
- •Diagnosis of psychotic disorder
- •Diagnosis of alcohol or drug dependence
- •Diagnosis of learning disability or autistic spectrum disorder
- •English language skills not adequate for therapy
- •Previous treatment with Schema Mode Therapy
- •Unable to make realistic commitment to attend weekly appointments
结局指标
主要结局
Eating Disorders Examination questionnaire (EDE-Q)
时间窗: 6 monthly
A validated self-report measure of eating disorder symtpoms.
次要结局
- Symptom Check List - 90(6 monthly)
- Body Mass INdex (BMI)(6 monthly)
- WHO-QoL (bref)(6 monthly)
- Global Assessment of Functioning (GAF)(6 monthly)
