Pilot Study of a Practice Nurse Supported Psychological Self-help Intervention for Patients With Diabetes or Coronary Heart Disease and Co-morbid Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- The obstacles to providing access and support to a generic online self help computerised cognitive behavioural therapy (CBT) programme for such patients.
研究概览
简要总结
A feasibility pilot trial of the self-help, "Cognitive behavioural therapy" based "Living Life to the Full" Materials for use by patients with diabetes type 2 and / or coronary heart disease.
详细描述
Depressed mood is common in patients with chronic disease and physical disability. It adversely affects quality of life, adherence to treatment and clinical outcome. Depression is expensive to the person, their family, employers and society. Recent developments in the UK General Practitioners' Contract mean that patients with two chronic diseases (Coronary Heart Disease- CHD and Diabetes - DM) are routinely screened for depression using a simple screening tool. We propose a study using an existing self help intervention in the specific context of patients with mild to moderately severe depression identified in this way.
This RCT is the second phase of a 2 phase mixed methods study examining the feasibility of a Full RCT. The first involved focus group with patients and health practitioners.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have had a diagnosis of diabetes mellitus type 2 and / or coronary heart disease.
- •Be aged 35 or over.
- •Be attending a participating primary care practice.
- •Have a depression severity scale rating indicating moderate to moderately severe depression, such as:Prime-MD-PHQ9 of 10-21; HADS-D of 8-15;BDI-2 of 23-44
排除标准
- •Unable to provide informed consent to participate
- •Already receiving psychological treatment for their depression
- •Have commenced treatment with an SSRI within the past 8 weeks
- •Likely to have difficulty communicating by telephone
- •Likely to have difficulty completing the forms and questionnaires
- •Have a serious physical disorder
- •Have a serious mental disorder
- •Express significant suicidal thoughts (PHQ9 or BDI-2 question 9 scoring >1)
- •Took part in an earlier related focus group
研究组 & 干预措施
Usual care
Self-help CBT
A nurse supported self-help CBT intervention in addition to usual care.
干预措施: Living Life to the Full (Behavioral)
结局指标
主要结局
The obstacles to providing access and support to a generic online self help computerised cognitive behavioural therapy (CBT) programme for such patients.
时间窗: 13 weeks
次要结局
- A change in depression (BDI-2), anxiety , social function (WASAS), quality of life (Euroqol 5D) or illness perception (IPQ-R) from participation in a self help programme.(13 weeks)
- The proportion of patients would prefer or require a non-computerised treatment alternative to treatment (i.e. a book or DVD based form of the treatment).(13 weeks)
- The uptake, satisfaction with and completion of the self help programme when promoted and supported by practice nurses.(13 weeks)