Early Interventions for Primary Care Patients With Stress-related Ill-health: a Randomized Controlled Non-inferiority Trial of a Collaborative Care Intervention vs. Cognitive Behavior Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Perceived Stress Scale (PSS-10)
研究概览
简要总结
Stress-related ill-health is rated one of the largest health challenges in the western world. The most empirically supported treatment for stress-related disorders is cognitive behaviour therapy (CBT), but accessibility is low and most patients in primary care do not receive this evidence-based treatment. Collaborative care has been shown to be an effective working model for primary care patients with mental health problems. This type of care intervention has however not been compared against CBT, which is arguably the gold standard treatment for this patient group. The overarching purpose of this project is to investigate if implementation of two treatment models - collaborative care and therapist-guided self-help CBT -can be effective as early interventions for primary care patients with stress-related ill-health.
详细描述
Stress-related ill-health is rated one of the largest health challenges in the western world. The most empirically supported treatment for stress-related disorders is cognitive behaviour therapy (CBT), but accessibility is low and most patients in primary care do not receive this evidence-based treatment. Collaborative care has been shown to be an effective working model for primary care patients with mental health problems. In this study collaborative care is conducted by a nurse who provides the patient with self-management support. This intervention has been implemented at Gustavsbergs primary care clinic in Stockholm as a means to increase accessibility and quality of care for the large group of patients with stress-related ill-health. This type of care intervention has however not been compared against CBT, which is arguably the gold standard treatment for this patient group.
Our research group has developed and tested a therapist-guided self-help CBT (SH-CBT) that can be delivered online or as a self-help book with support by a clinician for stress-related ill health, which has been shown to be effective and also potentially very suitable for the primary care context. The overarching purpose of this project is to investigate if implementation of two treatment models - collaborative care and SH-CBT - can be effective as early interventions for primary care patients with stress-related ill-health.
Main research question: Is a brief collaborative care intervention provided by a nurse at least as effective as SH-CBT delivered by a psychologist for primary care patients with mild to moderate symptoms of stress?
Note: In may 2022, the research group made revisions to the study procedures in terms of administration format of CBT and inclusion criteria. These specific changes were made: (1) Participants randomized to SH-CBT are allowed to choose if they want to receive the treatment as therapist-guided online CBT or as therapist-guided bibliotherapy CBT. Participants are exposed to the same treatment content, but in the former case the material is presented on a secure website with asynchronous written therapist support and in the latter case the content is provided through a self-help book and the participant has 2-5 face-to-face appointments with the therapist; (2) It is no longer required that participants has adjustment disorder, instead participants have to have (a) a score on the Perceived Stress Scale-10 of 20 or higher, (b) stress-related ill-health as their principal problem, and (c) a duration of their problems of at least 1 month; (3) The sick-leave criterion is changed so that participants to be included are allowed to have been on full time sick-leave for maximum 2 months (instead of 50% for maximum 1 month).
The revisions described above were made in order to better operationalize the patient population "patients with mild to moderate stress-related ill-health" and to increase the recruitment of participants to the study. When the revisions were implemented approximately 20 participants had been included in the study. The revisions were approved by the Swedish Ethical Review Authority (ID 2022-00990-02).
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 16 years of age
- •A score of 20 or higher on the Perceived Stress Scale-10
- •Stress-related ill-health is the principal problem
- •Duration of problems for at least 1 month
- •Have symptoms in the mild to moderate range
- •Be able to read and write in Swedish
- •Have access to a computer with Internet connection
- •If the participant is on sick leave then the sick leave period should have a maximum duration of 2 months (full time sick-leave for 2 months is thus allowed)
排除标准
- •Ongoing other psychological treatment for stress-related problems
结局指标
主要结局
Perceived Stress Scale (PSS-10)
时间窗: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up
Change in PSS at post-treatment and follow-up compared to baseline (scale range 0-40, higher score means more symptoms)
次要结局
- EuroQol 5D (EQ5D)(Baseline, week 12 (post-treatment), 1-year follow-up)
- Sick leave(1 year from baseline)
- Insomnia Severity Index (ISI)(Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up)
- Generalized Anxiety Disorder-7 (GAD-7)(Baseline, week 12 (post-treatment), 1-year follow-up)
- Shirom-Melamed Burnout Questionnaire (SMBQ)(Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up)
- Brunnsviken Brief Quality of Life Index (BBQ)(Baseline, week 12 (post-treatment), 1-year follow-up)
- Trimbos and Institute of Medical Technology Assessment of Cost Questionnaire for Psychiatry (TIC-P)(Baseline, week 12 (post-treatment), 1-year follow-up)
研究者
Erik Hedman
Principal investigator
Karolinska Institutet