跳至主要内容
临床试验/NCT04859647
NCT04859647已完成不适用

Client-led Online Therapy for People Diagnosed With Bipolar Disorder

University of Manchester1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年6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
已完成
入组人数
10
试验地点
1
主要终点
Feasibility of Study through recruitment of participants

研究概览

简要总结

The study aims to investigate the use of Method of Levels therapy (MOL) delivered online via videoconferencing for people who have received a diagnosis of a bipolar spectrum disorder. People are typically offered medication and talking therapies aimed at reducing symptoms and managing relapse. Research shows, however, that people tend to report reasons for distress other than symptoms and prioritise a fulfilling, purposeful life over remaining relapse- free. Having choice and control over treatment have been identified as important aspects of recovery in bipolar disorder.

MOL is a flexible, client-led psychological therapy that allows people to talk freely about important problems and life goals. MOL has already been applied to a range of mental health difficulties with promising results.

The aims of the study are to:

  • Investigate whether it is feasible to deliver MOL online to people with a bipolar spectrum disorder
  • Investigate whether MOL delivered online is an acceptable psychological intervention for people with a bipolar spectrum disorder
  • Identify the elements of therapy that people want choice over and the impact and importance of these elements
  • Determine whether there is a link between how much control over therapy people perceive themselves to have and the degree to which they generate new perspectives, thoughts and insights into their problems.

The current study will aim to recruit a minimum of 12 participants with a diagnosis of Bipolar Spectrum Disorder to account for 30% attrition (a conservative estimate based on reported attrition rates for published studies evaluating Cognitive Behavioural Therapy (CBT) for Bipolar Disorder). Therefore, the study aims to retain 8 participants for completion of the study. This is considered feasible in the available timeframe as recruitment will adopt a broad strategy. Participants will be offered MOL sessions online for up to six months. Potential participants will choose how many sessions to have, when to attend and what to talk about. Investigators will consider how many participants chose to take part and remain in the study to the end. The investigators will also ask participants about their experiences of the intervention and any changes participants may have noticed via feedback questionnaires and an interview.

详细描述

Bipolar spectrum disorder (previously known as manic depression) is a diagnostic term used to describe experiences of extreme, and sometimes enduring, fluctuations in mood that interfere with a person's life or cause significant distress. Individuals diagnosed with bipolar disorder experience periods of depressed mood and periods of elevated or irritable mood. In many cases, this amounts to clinical depression, or mania that entails hospital admission. Periods of mood fluctuation usually involve extreme changes to usual thinking and behaviour. During a period of depression people might feel hopeless and suicidal, withdraw from social activities and have difficulty functioning, resulting in a neglect of self-care and basic needs. During mania people might experience delusional beliefs, become highly distractible and prone to engaging in high-risk activities such as excessive spending or drug-taking. Both mood states can result in significant impairment in work, social or daily functioning and may result in hospitalisation.

Many people with a diagnosis of a bipolar spectrum disorder experience multiple relapses, causing them significant long-term disability. Meeting the needs of this client group can pose a real challenge for services given the complexity of fluctuating mood states, high levels of impulsivity and associated risk, and additional difficulties that people can also experience (such as anxiety and trauma).

Current guidelines recommend that people who have received a diagnosis of a bipolar spectrum disorder are offered an evidence-based psychological intervention as well as medication. These interventions are typically time-limited and guided by a specific manual with emphasis on alleviating symptoms and relapse prevention. The quality of the evidence supporting such interventions has been questioned. There has also been doubt cast on the effectiveness of these interventions.

Treatment adherence is also considered suboptimal, with relatively high drop-out rates. Access to talking therapies for those with complex needs has been described as 'notoriously poor'. People diagnosed with a bipolar spectrum disorder often report reasons for distress other than symptoms and prioritise a fulfilling, purposeful life over remaining relapse-free. Talking freely to a caring, approachable therapist is valued, as are interventions that facilitate control over aspects of life beyond mood. Recovery is achievable when people are empowered to follow a self- determined path, take ownership and confront longstanding problems.

Recent advances in cognitive therapy have departed from traditional relapse prevention to offer a theory-based approach that helps people understand their individual experience of bipolar spectrum disorder and target current problems and control over life goals (rather than focusing on controlling swings). Although patients perceived the intervention to be beneficial, a trial did not find significant improvement compared to treatment as usual. Patients wanted more sessions and greater flexibility in scheduling, and many reported problems beyond their diagnosis.

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

  • •People aged 18 years and over
  • •Individuals with a diagnosis of Bipolar Spectrum Disorder.
  • •People accessing services or third sector agencies and/ or living in England.
  • •Access to personal use of technology is required for online therapy.

排除标准

  • •People presenting with extreme risk to self or others and engaging in active suicidal thoughts and/or behaviours.
  • •Problems of an organic nature, such as a brain injury or learning disability that might affect cognitive functioning.
  • •People already receiving a talking therapy for their difficulties
  • •People unable to speak/ understand sufficient English.
  • •Anyone already receiving talking therapy at the time of enrolment
  • •Anyone with a diagnosis of schizophrenia, schizoaffective disorder, primary substance misuse (mood swings caused purely by substance misuse), or psychosis outside of mood episodes or current episode of mania.
  • •People who do not have access to the internet and a video calling device.

研究组 & 干预措施

Therapy Intervention

Other

Method of Levels Therapy Intervention - Clients will choose how many sessions to attend during the 6 months therapy window. Clients will also choose how often to attend sessions and the duration of each session.

干预措施: Method of Levels Therapy (Other)

结局指标

主要结局

Feasibility of Study through recruitment of participants

时间窗: Through study completion, up to 6 months

Feasibility will be measured by the proportion of eligible people recruited (based on the number of eligible referrals who chose to participate). These multiple measurements of feasibility will be combined to calculate an overall percentage of completion. Based on a recent trial with this client group, the percentage of eligible people needed to be recruited, remain in the study and complete the outcome measures to signal feasibility will be set conservatively at 50 percent. The number of sessions cancelled or terminated prematurely due to technical problems will also be considered.

Feasibility of Study through retention of participants

时间窗: Through study completion, up to 6 months

Feasibility will be measured by participant retention rates (the number of people that remain in the study until the end of the study). These multiple measurements of feasibility will be combined to calculate an overall percentage of completion. Based on a recent trial with this client group, the percentage of eligible people needed to be recruited, remain in the study and complete the outcome measures to signal feasibility will be set conservatively at 50 percent. The number of sessions cancelled or terminated prematurely due to technical problems will also be considered.

Feasibility of Study through data completion

时间窗: Through study completion, up to 6 months

Feasibility will be measured by the proportion of data completion (the number of outcome measures completed by participants during the study). These multiple measurements of feasibility will be combined to calculate an overall percentage of completion. Based on a recent trial with this client group, the percentage of eligible people needed to be recruited, remain in the study and complete the outcome measures to signal feasibility will be set conservatively at 50 percent. The number of sessions cancelled or terminated prematurely due to technical problems will also be considered.

Acceptability of Intervention through written feedback

时间窗: Through study completion, up to 6 months

The key measure of acceptability will be a content analysis of written feedback comments. Feedback relating to quality of connection, audio, and video, and any impact of technological problems will also be considered. Descriptive statistics for the number of sessions attended, cancelled, not attended without prior notice, and the length of sessions will be provided. Where participants cancel or fail to attend a prearranged session, drop out of the study, or book few or no sessions, attempts will be made to ascertain the reasons. The collective data will determine whether the intervention would be considered acceptable by participants. A post-treatment retention rate of at least 75 percent would be considered to indicate acceptability in this study.

次要结局

  • Working Alliance Inventory - Short Version Revised (WAI-SR; Paap & Dijkstra, 2017).(During the Intervention, up to 26 weeks)

研究者

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

Kadie-Charelle Roberts

Trainee Clinical Psychologist

University of Manchester

研究点 (1)

Loading locations...

相似试验