HEADS: UP (Helping Ease Anxiety and Depression Following Stroke) Psychological Self-management Intervention: a Randomised Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Beck Depression Inventory II (change being assessed)
研究概览
简要总结
A mixed methods randomised controlled pilot trial, conducted in miniature of future definitive trial, in which the investigators will test optimised intervention and study processes. The investigators will individually randomise stroke survivor participants in a 1:1 allocation to: HEADS: UP or Control.
详细描述
AIM To test full-study procedures and determine whether to proceed to a future definitive trial.
Objectives
- Test full-study procedures, including measurement logistics, randomisation, and check the direction of effect is in the expected direction.
- Identify potential resource (cost) implications of delivering HEADS: UP and potential impact on NHS utilisation.
- Determine whether to proceed to a future Phase III definitive trial.
METHODS
SETTING: HEADS: UP will be delivered online, via Zoom or MS Teams according to Trainer preference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Aged ≥18 years
- •Have had ≥1 stroke at least 3 months previously
- •Able to speak and understand conversational English DESIRABLE BUT NOT ESSENTIAL: Able to identify a family member* who would: like to take part and can speak and understand conversational English.
- •Family member: we use an inclusive definition of 'family': 'a self-identified group of two or more individuals who consider themselves as 'family' e.g. spouse, parent, friend. When we refer to 'family' in this document our meaning extends beyond 'family', to friends, peers and volunteers/buddies.
排除标准
- •Prior MBSR attendance in the last three years (as this may confound results)
- •Current participant in another trial of a similar psychological self-management intervention
- •Currently receiving treatment for PTSD (post traumatic stress disorder) or psychosis
- •Disclosing suicidal ideation
- •Cannot follow a 2-stage command e.g. Please spell your surname and then tell me the days of the week; Please count to six and then spell your first name.
- •Scores <3 on the PHQ-4
结局指标
主要结局
Beck Depression Inventory II (change being assessed)
时间窗: Weeks 0, 8, 20, 32 (assessing change)
The Beck Depression Inventory II is a 21-item self-report scale to assess the intensity of depression. Each item is a list of four statements arranged in increasing severity about a symptom of depression. Score range between 0-63 with higher score indicating greater severity.
Beck Anxiety Inventory (change being assessed)
时间窗: Weeks 0, 8, 20, 32 (assessing change)
The Beck Anxiety Inventory is a self-report 21-item scale for measuring anxiety. The questions ask about symptoms of anxiety the subject has had during the past week. Each question is scored between 0 (mild) and 3 (severe) and a total score will vary between 0-63. Higher scores indicate more severe anxiety symptoms.
Depression Anxiety Stress Scales (change being assessed)
时间窗: Weeks 0, 8, 20, 32 (assessing change)
The Depression Anxiety Stress Scale is a 21-item version of the full 42-item scale, consisting of a set of three self-report scales designed to measure depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items. Participants are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week. Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items and multiplying by two to produce the equivalent DASS-42 score. Higher scores suggesting more severe difficulties.
次要结局
- EQ-5D 5L (change being assessed)(Weeks 0, 8, 20, 32 (assessing change))
- Short Form Stroke Impact Scale (change being assessed)(Weeks 0, 8, 20, 32 (assessing change))