NCT02352870已完成不适用
Intervention for Improving Psychological Distress in Dialysis (iDiD) Feasibility Two Arm Randomised Controlled Trial: Online Cognitive Behavioural Therapy (CBT) Intervention With Therapist Support vs Online CBT Intervention Alone (no Therapist Support)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7)
研究概览
简要总结
To explore whether it is feasible to recruit and retain haemodialysis patients into a randomised controlled trial of online cognitive-behavioural therapy to manage distress
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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 or over and receive hospital haemodialysis three-times weekly
- •Presence of mild to moderately severe depressive symptoms (based on PHQ-9 scores of 5 to 19 in range; a self-report measure of depression) and/or presence of mild to moderate anxiety symptoms (based on GAD-7 scores of 5-14)
- •Speak English sufficiently well to engage with screening tools
- •Have a basic understanding of how to use the Internet and an email address
- •Have a minimum dialysis vintage of ≥3 months (electronic patient record)
排除标准
- •Hospitalised at the time of assessment or within 1 month prior to the assessment
- •Currently receiving active treatment for depression and/or anxiety. We consider active treatment to be any current psychological treatments (talking therapies) or receipt of a new anti-depressant and/or anti-anxiety medication. A medication is considered new if it is commenced three months prior to the completion of the depression and anxiety screening questionnaire
- •Severe mental health disorders, for example, psychosis, bi-polar disorder
- •Active suicidal thoughts-any participant that scores greater than one on the depression PHQ-9 item "Thoughts that you would be better off dead, or of hurting yourself" will be excluded from the study.
- •Evidence of addiction to alcohol or drugs
结局指标
主要结局
Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7)
时间窗: Baseline recruitment/screening
Record the number of patients approached for screening and their consent rate
次要结局
- Adherence to the online intervention + telephone support calls (therapist supported arm only)(12 weeks follow-up)
- Recruitment , randomisation, and retention rates(Screening, baseline, and 12 weeks follow-up)
- GAD-7 (A self-report 7 item measure of anxiety)(Change in anxiety from baseline to 12 weeks)
- PHQ-9 (A self-report 9 item measure of depression)(Change in depression from baseline to 12 weeks)
- EQ-5D (A self-report measure of quality of life)(Baseline and 12 weeks follow-up)
- Client Service Receipt Inventory (A self-report measure of health service utilisation)(Baseline and 12 weeks follow-up)
- Satisfaction with treatment (A 2 item measure generated for the purposes of present study)(Baseline and 12 weeks follow-up)
- Brief Illness Perceptions Questionnaire(Baseline and 12 weeks follow-up)
研究者
研究点 (2)
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