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临床试验/NCT06882590
NCT06882590尚未招募不适用

A Brief Compassionate-focused Intervention for Older People with Bipolar Disorder

University of Manchester1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
6
试验地点
1
主要终点
Number of therapy sessions attended

研究概览

简要总结

The aim of this study is to determine whether it is feasible to deliver a 9-session compassionate-focused therapy for older people with bipolar disorder. Participants will be asked to complete baseline measures and at post-intervention follow-up (12 weeks and 24 weeks) to understand any potential clinical benefits of the therapy.

详细描述

The present study will evaluate the feasibility of a compassionate-focused intervention targeting rumination that is specifically tailored for older people with bipolar disorder. In addition to evaluating its feasibility, the study will also investigate whether there are any clinical benefits associated with the intervention, namely, any potential reductions in negative rumination and feelings of guilt and shame. To date, there has been no research evaluating the feasibility of this type of intervention.

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
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 60 years and above.
  • •Have a nominated healthcare professional (i.e. GP/Care Coordinator)
  • •Meet the criteria for a diagnosis of bipolar disorder I or II according to the MINI.
  • •Score of >57 on Ruminative Response Scale (RRS)
  • •Be able to provide written informed consent.
  • •Be able to speak sufficient English to engage in the assessments and intervention.

排除标准

  • •Currently in an episode of mania or hypomania according to the MINI.
  • •Experiencing 'severe depression' according to the Hamilton Depression Rating Scale, which equates to a score of over
  • •MoCA score of <22 to exclude for moderate and severe cognitive impairment.
  • •Currently receiving psychological therapy.

研究组 & 干预措施

Therapy participants

Other

Participants to receive the compassionate-focused therapy

干预措施: Compassionate-focused therapy (Other)

结局指标

主要结局

Number of therapy sessions attended

时间窗: The timeframe for number of therapy sessions attended will span the length of intervention; from the first assessment session to final therapy session. The estimated period of time over which the event is assessed is up to 9 weeks.

The primary outcome of the study is the feasibility of the compassionate-focused intervention, which will be measured using the above metric.

Number of participants who drop-out and at which stage of the intervention

时间窗: The time frame covers first therapy session to final therapy session. The estimated period of time over which the event is assessed is up to 9 weeks.

The primary outcome of the study is the feasibility of the compassionate-focused intervention, which will be measured using the above metric.

次要结局

  • The Altman Self-Rating Mania Scale(Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up)
  • The Bipolar Recovery Questionnaire(Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up)
  • The Quality of Life in Bipolar Disorder Questionnaire(Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up)
  • Other as Shamer Scale(Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up)
  • Guilt and Shame Questionnaire(Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up)
  • The Compassionate Engagement and Action Scale(Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up)
  • Generalised Anxiety Disorder Questionnaire (GAD-7)(Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up)
  • Center for Epidemiologic Studies Depression Scale (CES-D)(Changes in outcome measure scores will be recorded from first baseline, to 12 weeks and 24 weeks follow-up)

研究者

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

Imogen Young

Doctoral Student (Trainee Clinical Psychologist)

University of Manchester

研究点 (1)

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