Acceptance and Commitment Therapy Self-help Intervention for Depression in Haemodialysis Patients: A Feasibility Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- Change in Patient Health Questionnaire (PHQ-9) at 2 and 4 months
研究概览
简要总结
The purpose of this study is to assess the feasibility of conducting a trial to evaluate a self-help treatment for depression in people with end-stage renal disease.
详细描述
Chronic Kidney Disease (CKD) is a long-term condition in which the function of the kidneys - to filter out waste products from the blood - slowly declines. When renal function becomes sufficiently low it is described as End Stage Renal Disease (ESRD) and renal replacement therapy (RRT) is likely to be needed to prolong life. The most common type of RRT is haemodialysis, in which the patient's blood is filtered through a machine.
It is estimated that depression is experienced by 20-40% of people with ESRD. Depression not only affects the quality of life of individuals with ESRD but is also associated with higher rates of hospitalisation and poorer physical health outcomes.
Acceptance and Commitment Therapy (ACT) has been found to be an effective treatment for depression and has been used successfully as a self-help treatment. However, no study has examined the effectiveness of an ACT self-help treatment for depression in ESRD. This study aims to assess the feasibility of conducting such a study and will look at suitability of recruitment, assessment methods and the acceptability of the self-help treatment, as well as helping to calculate the number of people needed for a definitive study.
Haemodialysis patients receiving dialysis through an NHS renal service will be invited to participate. To participate they will be consenting, over 18 years of age and experiencing depressive symptoms at a clinical level. Those eligible will be randomly assigned into one of two conditions; a control condition receiving treatment as usual (TAU), and an intervention condition receiving TAU alongside an ACT self-help manual with weekly telephone support. The manual will be completed over six weeks. Both groups will be asked to complete questionnaires prior to intervention and 2 and 4 months post-intervention. Participants from each condition will be asked to participate in interviews to explore their experiences of taking part.
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
- •undergoing haemodialysis treatment at one of three identified units
- •receiving haemodialysis treatment for more than 6 months
- •moderate depression (as indicated by the PHQ-9)
排除标准
- •receiving concurrent psychological treatment
- •lacking mental capacity to consent due to cognitive impairment
- •inadequate reading ability (indicated by inability to complete PHQ-9 screening measure)
- •visual or hearing impairment that would prevent completion of the self-help book or engagement in telephone calls
结局指标
主要结局
Change in Patient Health Questionnaire (PHQ-9) at 2 and 4 months
时间窗: Baseline; 2 months; 4 months
Validated self-report questionnaire assessing symptoms of depression
次要结局
- Change in EQ-5D-5L at 2 and 4 months(Baseline; 2 months; 4 months)
- Change in Valued Living Questionnaire (VLQ) at 2 and 4 months(Baseline; 2 months; 4 months)
- Change in Acceptance and Action Questionnaire - 2 (AAQ-2) at 2 and 4 months(Baseline; 2 months; 4 months)
研究者
William Vogt
Trainee Clinical Psychologist
University of Lincoln