Better Sleep in Psychiatric Care - Clinical Feasibility and Preliminary Effects of CBT for Insomnia in a Mixed Psychiatric Sample at an Outpatient Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Number sessions attended by the participants
研究概览
简要总结
Between 50-80 percent of patients in psychiatry have insomnia-type sleep problems. In addition to reduced quality of life and impaired function, sleep problems can aggravate other psychiatric problems and increase the risk of relapse into, for example, depression. According to international guidelines, cognitive behavioral therapy for insomnia (CBT-i) should be used as the first choice for treatment of insomnia. In practice, however, it is very uncommon for psychiatric patients to be offered CBT-i, instead most are treated with sleep medications. There is also a lack of research studies evaluating CBT-i in regular clinical practice.
This pilot study investigated the feasibility of a group treatment with CBT-i at a psychiatric outpatient clinic in Stockholm for patients with depression, bipolar disorder II, anxiety syndrome and PTSD. Changes in symptoms of insomnia, depression, and anxiety after treatment were also investigated.
Patients with self-perceived sleep problems were offered a six-session group treatment based on CBT-i. The primary outcome was clinical feasibility, defined as: the influx of patients sufficient to start at least one group per semester (at least 8 patients); at least half of included patients participate in the first session; patients participate in at least half of the sessions; less than half of the patients drop out of treatment; group leaders find the treatment manual credible, easy to use and want to continue working with it after the study is completed.
Secondary outcomes were changes in insomnia symptoms, and changes in symptoms of depression and anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Being a patient at a specialist outpatient clinic treating these patient groups
- •Insomnia disorder or sleep problems of insomnia type
- •Over 10 points on the Insomnia Severity Index (ISI)
- •Adequate skills in written and spoken Swedish
- •No practical barriers to participate in the group treatment
排除标准
- •night shift work
- •ongoing alcohol or drug abuse that required treatment at a specialised unit
结局指标
主要结局
Number sessions attended by the participants
时间窗: Post-treatment (6 weeks)
Average number of sessions attended should be no less than 3
Number of participants dropping out of treatment
时间窗: Post-treatment (6 weeks)
Less than half of the patients should drop out of treatment
Number of participants registering to participate in the treatment
时间窗: Screening
Influx of patients should be sufficient to start at least one group per semester (at least 8 patients)
Qualitative measure of group leaders' perception of the manual
时间窗: Post-treatment (6 weeks)
Group leaders should find the treatment manual credible and easy to use, and be willing to continue using the treatment manual after the study is completed
Number of included participants attending the first treatment session
时间窗: First session (1 week)
At least half of included patients should attend the first treatment session
次要结局
- Insomnia Severity Index(Post-treatment (6 weeks), Three-month follow-up (21 weeks))
- Patient health questionnaire (PHQ-9)(Post-treatment (6 weeks), Three-month follow-up (21 weeks))
- Generalized Anxiety Disorder Assessment (GAD-7)(Post-treatment (6 weeks), Three-month follow-up (21 weeks))
研究者
Susanna Jernelöv
Associate Professor
Karolinska Institutet