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临床试验/NCT03424512
NCT03424512终止不适用

An Open Trial of Group Metacognitive Therapy for Anxiety and Depression in Cancer Survivors

University of Liverpool2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
15
试验地点
2
主要终点
Hospital Anxiety Depression Scale-Total (HADS-Total)

研究概览

简要总结

This study aims to test the potential of group metacognitive therapy in alleviating emotional distress in cancer survivors. The investigators aim to find out if a group based approach is acceptable to patients and feasible to deliver in a routine clinical health psychology service.

详细描述

Survival rates in cancer continue to improve, with over 2 million adult cancer survivors in the United Kingdom, projected to increase to 4 million by 2030. Around 25% of these survivors require treatment for clinical levels of emotional distress. Current pharmacological treatments are not very effective and are not well tolerated by patients, who prefer psychological treatments. However, meta-analyses of well-controlled studies of psychological treatments indicate that these achieve only small effect sizes. Reflecting this limited efficacy in the face of the need for psychological treatment, the National Cancer Survivorship Research Initiative highlighted development and evaluation of practically feasible interventions for depression and anxiety in cancer survivors as an urgent research priority. It is recognised that current influential psychotherapeutic approaches need to be modified to meet the specific needs associated with cancer. However modifications have been pragmatic rather than theory-driven and have not improved efficacy.

The study addresses the stages of 'development' and 'piloting and feasibility' in Medical Research Council guidance on intervention development, albeit with a relatively well-defined starting point given existing evidence for efficacy of metacognitive therapy (MCT) in other settings and promising preliminary evidence of applicability in cancer. The investigators will conduct a phase I open trial to test the potential efficacy of group MCT in cancer survivors and the hypothesised causal metacognitive mechanisms underpinning treatment response.

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

入选标准

  • Cancer diagnosis at least 6 months previously
  • A score of at least 15 on the Total scale score of the Hospital Anxiety and Depression Scale (HADS)
  • Sufficient understanding of English to consent and engage in therapy
  • Stable on, or free from, psychotropic medication
  • Minimum of 18 years old

排除标准

  • History of psychotic disorder, learning disability, or organic mental disorder
  • Risk of self-harm or suicide warranting immediate intervention
  • In palliative phase of treatment
  • Being considered for risk-reducing or reconstructive surgery within 1 year
  • Concurrent psychological intervention for emotional distress
  • Cognitive impairment precluding informed consent or participation
  • Undergoing acute medical treatment (e.g. chemotherapy, radiotherapy)
  • Current drug/alcohol abuse

结局指标

主要结局

Hospital Anxiety Depression Scale-Total (HADS-Total)

时间窗: Change in HADS total at up to 10 weeks through study completion

Measures severity of emotional distress

次要结局

  • Metacognition Questionnaire-30 (MCQ-30)(Change in MCQ-30 at up to 10 weeks through study completion)
  • Impact of Events Scale-Revised (IES-R)(Change in IES-R at up to 10 weeks through study completion)
  • Cognitive Attentional Syndrome-1 (CAS-1)(Change in CAS-1 at up to 10 weeks through study completion)
  • Fear of Cancer Recurrence Inventory (FCRI)(Change in FCRI at up to 10 weeks through study completion)
  • Functional Assessment of Cancer Therapy- General (FACT-G)(Change in FACT-G at up to 10 weeks through study completion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Fisher

Principal Investigator

University of Liverpool

研究点 (2)

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