跳至主要内容
临床试验/NCT02840071
NCT02840071Unknown不适用

Acceptance and Commitment Therapy for Individuals With Head and Neck Cancer Experiencing Psychological Distress: A Hermeneutic Single-Case Efficacy Design

University of Nottingham2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2016年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
3
试验地点
2
主要终点
Change in psychological flexibility assessed using the Problem Questionnaire (PQ)

研究概览

简要总结

Title: Acceptance and Commitment therapy for Individuals with Head and Neck Cancer Experiencing Psychological Distress.

Head and neck cancer (HNC) patients are particularly vulnerable to experiencing psychological distress . The current guidelines from the National Institute of Health and Care Excellence are that cognitive-behavioural therapy (CBT) is to be offered to adults with a long-term physical health condition experiencing anxiety and depression. CBT has been shown to have several inadequacies for individuals with physical health conditions such as cancer. Acceptance and commitment therapy (ACT) takes an alternative approach to CBT, aiming to change a person's interaction with their thoughts rather than suppress or alter thought content. Although studies indicate encouraging findings for the effectiveness of ACT for individuals with breast cancer; the HNC- transfer-ability of findings is yet untested, and there is a need to evaluate the replicability of ACT effects in people living with HNC, given the unique challenges inherent to the disease and its treatment.

This study aims to inform clinical practise by using a hermeneutic single-case efficacy design (HSCED) to answer the following questions:

  1. Is there evidence of psychological change after the introduction of the ACT intervention?
  2. If present, are the changes attributable to (a) ACT components, (b) common factors, and/or (c) non-therapeutic factors?

The study will involve recruiting three adults with HNC from specialist HNC psychology services. Each participant will have six individual sessions of ACT and complete various process and outcome questionnaires during sessions. Following the intervention, participants will have a semi-structured interview where their views of the therapy and any changes made will be explored. Two outcome measures will be posted to participants at 1-month and 3-month post intervention.

详细描述

This study aims contribute to the theoretical literature on acceptance and commitment therapy (ACT) as well as the processes of psychological change for patients with head and neck cancer (HNC). Unlike some other cancer sites, the physical and emotional impact of living with HNC can be detrimental to the fundamental aspects of an individual's life (such as breathing, eating, hearing), and also cause significant changes to physical appearance. This forms the basis for specialised research of HNC patients. There is a tendency within the current cancer literature towards researching and understanding and other types of cancer or grouping HNC patients into heterogeneous cancer samples, leaving an evident gap of knowledge. Studies that have assessed the effectiveness of ACT mirror this trend, using either breast cancer or heterogeneous cancer samples.

Employing a single-case method with both quantitative and qualitative components will give a more precise understanding of the processes within ACT that are helpful and most importantly, why. This may have direct implications for informing the on-going practice of professionals working therapeutically using ACT, enabling them to refine interventions and focal principles. In support of this, a recent review of ACT interventions concluded that although efficacy of ACT is probable, there is a lack of knowledge of how it works. Single-case research is a pragmatic first step in exploring the efficacy of ACT for HNC patients and increasing understanding of the potential mechanisms of change. A Hermeneutic Single Case Efficacy Design for three participants will be used. This is a legalistic single case study method which allows the assessment of intervention effects in single therapy cases within a naturalistic clinical context. It uses a mixture of qualitative(change interview) and quantitative methods (questionnaires) to create a set of evidence that allows detection of causal links between therapy process and outcome.

In order to minimise the risk of coercion, a member of the patients care team (Clinical Psychologist) will be the first point of contact for potential participants, introducing waiting-list patients to the research and giving them the information sheet if they verbally indicate interest. After reading the information sheet, if they verbally agree to continue with the research, they will be put into contact with the researcher who will answer any additional questions, ensuring that the person has sufficient time to consider participating or not. Written informed consent will be collected from each participant before they undergo any intervention related to the study. One copy of this will be kept by the participant, one will be kept by the researcher, and a third will be retained in the patient's hospital records.

Informed consent will be gained in accordance with the Research Ethics Committee (REC) guidance, and Good Clinical Practice (GCP) and any other regulatory requirements that might be introduced. The researcher and the participant will both sign and date the informed consent form before the person can participate in the study. The researcher will emphasise to them that consent regarding study participation is entirely voluntary and may be withdrawn at any time without penalty or affecting their care. For example, if the patient withdraws from the study, they will return to the point of the psychological therapy waiting list that they were taken from, therefore not affecting the length of time they have to wait to see a therapist. There will be no monetary incentive to take part in the research, reducing the risk of coercion.

This research aims to use a sample most representative of individuals in clinical practice, therefore site and stage of HNC does not feature the inclusion criteria. The GAD-7 (generalised anxiety disorder) and PHQ-9 (patient health: depression) questionnaires will be used using 'caseness' thresholds for anxiety and/or depression as these are widely used and the current screening method for most psychology therapy services.

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

  • •Participants taking part must:
  • •Be above the age of 18
  • •Have capacity to give informed consent (assessed by the clinical psychologist within the service)
  • •Able to understand and speak the English language
  • •Have a diagnosis head and neck cancer
  • •Experiencing psychological distress (assessed using anxiety and depression screening tools)
  • •Have the ability to attend relevant hospital for study participation

排除标准

  • •N/A see above

研究组 & 干预措施

Intervention

Experimental

Psychological therapy.

干预措施: Psychological therapy (Other)

结局指标

主要结局

Change in psychological flexibility assessed using the Problem Questionnaire (PQ)

时间窗: up to 18 weeks

Changes in the problem questionnaire (PQ) (administered pre and post intervention) will also be used as an indirect measure of change in psychological flexibility. This measure consists of up to 10 unique problem statements that the individual has, rated on a 7-point likert scale. Significant reductions in these ratings would indicate an increase in psychological flexibility.

Change in psychological flexibility assessed using the Acceptance and Action Questionnaire (AAQ-II)

时间窗: up to 18 weeks

The primary goal of ACT is increasing psychological flexibility by enabling a person to change their relationship with distressing cognitions (acceptance) and do things that are personally meaningful to them (commit). The primary outcome will be an assessment of whether change has occurred using process measures (acceptance and action questionnaire: AAQ-II).

次要结局

  • Anxiety assessed by GAD-7 questionnaire(up to 18 weeks)
  • Depression assessed by PHQ-9 questionnaire(up to 18 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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