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临床试验/NCT04291547
NCT04291547已完成不适用

Computerised Behavioural Activation Programme for the Treatment of Depression in Young People: Feasibility Study

University of York1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining the percentage of those eligible who consented

研究概览

简要总结

The primary aim of this non-randomised feasibility study is to 1) examine the acceptability of a newly developed computerised Behavioural Activation programme (BALM) in treating young people experiencing low mood/depression and 2) assess the feasibility of undertaking a pilot Randomised Controlled Trial (RCT) of the intervention.

详细描述

Approximately 20% of adolescents will have had at least one depressive episode by the age of 18 making depression one of the leading causes of illness and disability in young people. Although receiving effective treatment is important, as few as 35% of young people seek help, with treatment-related issues (e.g. stigma, negative attitudes about help-seeking, accessibility, reluctance to engage one-to-one with a therapist, etc) outlined as reasons for this. Computerised therapies, which have increased availability and accessibility, reduced stigma and can be delivered in a format attractive to many young people may avoid some of these barriers and provide a more effective treatment option for young people.

Behavioural Activation (BA) - a type of talking therapy focused on increasing liked activities has demonstrated effectiveness in treating depression in adults and, owing to this, is an evidence-based treatment for depression within NICE (2009) guidelines. Despite this, less research has examined its use with young people.

We have developed BALM (Behavioural Activation for Low Mood), an online BA programme designed for use with young people experiencing mild to moderate low mood or depression. The development of BALM was based upon the findings of a systematic review and a series of qualitative interviews and focus groups with young people and healthcare professionals.

Eligible young people will be referred to the programme via healthcare professionals working in local Child and Adolescent Mental Health Services and mental health practitioners based in local secondary schools.

The findings of this research will allow us to refine the intervention and the research methods we employ in preparation for a pilot randomised controlled trial (RCT) of the new treatment.

研究设计

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

入排标准

年龄范围
11 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged 11 to 16 years at the date of consent
  • Experiencing low mood or depression symptoms as defined by a score of ≥20 on the Mood and Feelings Questionnaire
  • In agreement that their primary care provider and a parent/guardian can be informed of any concerns the lead researcher has about their wellbeing during participation

排除标准

  • Within the normal range on the measure of depressive symptoms (i.e. attaining a score of ≤19 on the Mood and Feelings Questionnaire)
  • Experiencing severe low mood or depression symptoms
  • Having a comorbid mental health diagnosis of Bipolar Disorder or Psychosis.
  • Non-English speaking (due to the small scope of this study, the option of providing translated versions of BALM and the outcome measures was not feasible)
  • Deemed to be actively at risk of self harm or suicide
  • Have no access to the internet and therefore no programme access

结局指标

主要结局

Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining the percentage of those eligible who consented

时间窗: 4 months

Assessed by examining the percentage of those eligible who consented to the study

To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining responses on an evaluation questionnaire

时间窗: 4 months

Assessed by examining responses on an evaluation questionnaire comprising 15 short questions

Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining questionnaire response rates

时间窗: 4 months

Assessed by examining questionnaire response rates

Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining session attendance

时间窗: 4 months

Assessed by examining session attendance

Feasibility of undertaking a pilot Randomised Controlled Trial of BALM by examining number and reasons for withdrawal

时间窗: 4 months

Assessed by examining number and reasons for withdrawal

To examine the acceptability of BALM in treating young people experiencing low mood/depression by examining session adherence

时间窗: 4 months

Assessed by examining session adherence

次要结局

未报告次要终点

研究者

发起方
University of York
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lucy Tindall

Principal Investigator

University of York

研究点 (1)

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