Investigating the Care That People With Diabetes Receive for Their Emotional Wellbeing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 7
- 主要终点
- To assess the socio-demographic and clinical reach of COMPASS.
研究概览
简要总结
The investigators want to understand the feasibility and acceptability of implementing COMPASS: Online Cognitive behavioural therapy (CBT) in routine NHS care for individuals with diabetes. People with type 1 or type 2 diabetes with co-morbid psychological distress will be invited to take part in a pre-post implementation study of COMPASS: Online CBT for managing depression and anxiety in context of Long-Term conditions (LTCs). Patients with diabetes who are also experiencing depression and/or anxiety and/or diabetes specific distress will be recruited from: Improving Access to Psychological therapies (IAPT) services or clinics within Guys and St Thomas National Health Service (NHS) trust (GSTT) in London, United Kingdom (UK).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
To assess the socio-demographic and clinical reach of COMPASS.
时间窗: To be collected throughout the study duration (the study will run for an average of 12 months).
Descriptive data, specifically frequencies documenting the number of individuals who are willing to use COMPASS, reasons documented for ineligibility/non-uptake and the sociodemographic and clinical profile of users vs non-users of COMPASS.
To examine: i) number of patients who require digital support to use COMPASS ii) monthly referrals to COMPASS by staff.
时间窗: To be collected at 12 weeks.
The investigators will use descriptive statistics to quantify the number of patients who require digital support to use COMPASS and ii) monthly referrals to COMPASS by staff.
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported physical health outcomes (listed below).
时间窗: To be collected at baseline, 12 weeks and 6 month follow up.
- Glycaemic control: self-reported HbA1c levels.
To examine barriers and facilitators to the adoption of COMPASS from the perspective of both staff and patients.
时间窗: To be collected at 12 weeks.
Semi-structured interviews will be conducted to explore patient and health care professional (HCP) perceptions of the barriers and facilitators of using COMPASS in the context of diabetes.
To assess the implementation of COMPASS in terms of patient adherence to COMPASS online sessions and number and duration of therapist support calls attended.
时间窗: To be collected throughout the study duration (the study will run for an average of 12 months).
Descriptive data on number of online sessions completed and number and duration of therapist support calls attended will be extracted from the COMPASS program.
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported mental health outcomes (listed below).
时间窗: To be collected at baseline, 12 weeks and 6 month follow up.
- General psychological distress: Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
To explore the potential efficacy of COMPASS by examining pre-post change scores on self-reported psychosocial outcomes (listed below).
时间窗: To be collected at baseline, 12 weeks and 6 month follow up.
- Loneliness: The revised University of California Los Angeles Loneliness scale (UCLA-R)
次要结局
未报告次要终点