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临床试验/NCT03537040
NCT03537040已完成不适用

A Pilot Study to Assess the Feasibility and Acceptability of a Novel Intervention to Help People Think About Their Neuroleptic Medication Use.

University of Manchester3 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2018年6月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
3
主要终点
Number of participants recruited to the study

研究概览

简要总结

The aim of the current study is to pilot a novel intervention to help people explore their decision making around the use of neuroleptic medication. A case series design will be used, with outcome variables measured at multiple time points pre-, during- and post-intervention. Participants will also be asked to complete an evaluation interview post-intervention. The primary aim is to investigate the feasibility and acceptability of offering the intervention.

详细描述

Many service users experiencing psychosis are prescribed neuroleptic medication as the core component of treatment. However, discontinuations rates are high, which may be influenced by poor response rates and scepticism about the value of medication.

Frequently people discontinue without professional involvement, which is associated with negative outcomes. It is a particularly high risk period for relapse, especially if withdrawal is done quickly. There is an urgent need to advance practices in helping service-users to make a decision regarding neuroleptic medication that can then be supported by clinicians.

Current interventions regarding medication use predominantly focus on increasing adherence to medication regimes using, for example, financial incentives. This raises ethical concerns over the potential for service users' priorities and preferences to be disregarded, leading to increased coercion and reduced empowerment for service users. The recovery movement emphasises the need to understand personal priorities when considering treatment options and informed choice and shared-decision making is promoted by government initiatives and practice guidelines.

Shared decision-making commonly occurs within physical health settings. Patient decision aids have been found to improve patients' knowledge of available options and help patients to have more accurate expectations of potential benefits and harms, reach choices that are more consistent with personal values and participate in decision making. Despite this, shared-decision making has not been adopted more widely and is particularly poor within mental health settings.

The current study aims to explore the feasibility and acceptability of an intervention aimed at helping service users in mental health services think about their own personal priorities and decision-making around medication use. Current psychological interventions, such as cognitive behavioural therapy (CBT) and motivational interviewing (MI), view decision-making in terms of individuals making cost-benefit analyses, which then informs their "planned" behaviour. Such interventions thus target the identification of desirable medication related behaviours and then help the individual to make those behaviours occur.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 16 years of age
  • Capacity to provide informed written consent
  • Able to converse in English proficiently
  • Currently under the care of an Early Intervention Service or Community Mental Health Team
  • Ambivalent around medication use
  • Experience of psychosis
  • Be able to be assessed in an outpatient facility (exceptions will be made for disabilities)

排除标准

  • If currently experiencing such a deterioration in mental state that they may have difficulties making decisions in their life
  • If significant risk of harm to self or others is present
  • If there is an organic basis for psychosis

研究组 & 干预措施

Method of Levels

Other

Talking therapy- duration and frequency of sessions to be determined by participant

干预措施: Method of Levels (Other)

结局指标

主要结局

Number of participants recruited to the study

时间窗: through study completion, an average of 5 months.

Number of participants recruited to the study

Number of participants retained during the study

时间窗: through study completion, an average of 5 months.

Number of participants retained during the study

Change in therapeutic alliance from baseline to 12 weeks

时间窗: baseline, 12 weeks.

The Session Rating Scale is a brief therapeutic alliance measure designed for every session clinical use. The SRS is a four-item visual analogue instrument that explores the relationship, goals and topics, approach or method, and how the client perceives the session in total. Scores range between 0 and 40, higher scores suggest better therapeutic alliance.

次要结局

  • Change in engagement with services from baseline to 12 weeks(baseline, 12 weeks.)
  • Change in attitude towards medication from baseline to 12 weeks(baseline, 12 weeks.)
  • Change in compliance to medication regime from baseline to 12 weeks(baseline, 12 weeks.)
  • Change in personal recovery from baseline to 12 weeks(baseline, 12 weeks.)
  • Change in treatment-related empowerment from baseline to 12 weeks(baseline, 12 weeks.)

研究者

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

Rea Dicks

Trainee Clinical Psychologist

University of Manchester

研究点 (3)

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