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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 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
研究组 & 干预措施
Computerised CBT with therapist support
Participants complete seven online cognitive behavioural therapy sessions weekly plus they receive three telephone support calls. The content of each of the sessions are summarised below:
Session 1: Psycho-education about end-stage renal failure Session 2: Generation of CBT "hot cross bun" model of psychological distress Session 3: Coping strategies for managing negative emotions, including: acceptance, relaxation, expression and tips for improving sleep quality.
Session 4: Identifying and challenging unhelpful thoughts Session 5: Goal setting and problem solving Session 6: Managing difficult social relationships Session 7: Progress recap and preparing for the future
In addition to completing the seven online sessions the intervention arm received three 30 minute telephone support calls at weeks two, four, and six to facilitate engagement and understanding of the contents of the website.
干预措施: Computerised Cognitive Behavioural Therapy (Behavioral)
Computerised CBT with therapist support
Participants complete seven online cognitive behavioural therapy sessions weekly plus they receive three telephone support calls. The content of each of the sessions are summarised below:
Session 1: Psycho-education about end-stage renal failure Session 2: Generation of CBT "hot cross bun" model of psychological distress Session 3: Coping strategies for managing negative emotions, including: acceptance, relaxation, expression and tips for improving sleep quality.
Session 4: Identifying and challenging unhelpful thoughts Session 5: Goal setting and problem solving Session 6: Managing difficult social relationships Session 7: Progress recap and preparing for the future
In addition to completing the seven online sessions the intervention arm received three 30 minute telephone support calls at weeks two, four, and six to facilitate engagement and understanding of the contents of the website.
干预措施: Telephone support (Behavioral)
Computerised CBT without therapist support
Participants complete seven online cognitive behavioural therapy sessions weekly but do not receive any telephone support calls. The content of each of the sessions are summarised below:
Session 1: Psycho-education about end-stage renal failure Session 2: Generation of CBT "hot cross bun" model of psychological distress Session 3: Coping strategies for managing negative emotions, including: acceptance, relaxation, expression and tips for improving sleep quality.
Session 4: Identifying and challenging unhelpful thoughts Session 5: Goal setting and problem solving Session 6: Managing difficult social relationships Session 7: Progress recap and preparing for the future
干预措施: Computerised Cognitive Behavioural Therapy (Behavioral)
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)