Evaluation of PCBH in Primary Care With or Without Additions of Guided Self-help CBT - a Single-blind Randomised Clinical Trial and Preparation for a Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 4
- 主要终点
- WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (4 domains)
研究概览
简要总结
The overarching goal of primary care is to offer all patients individualized and context-sensitive healthcare with high access and continuity. One of the reasons primary care struggles with this goal is that many patients suffer from mental health problems, while there is a lack of psychosocial resources as well as clear pathways for these patients.
Primary care behavioural health (PCBH, in Swedish IBH) is an innovative way of organizing primary care, where psychosocial resources have more and shorter visits, strive for same-day access, and have an active consulting role in the primary care team. To help patients with achieving relevant behavior changes, so called Brief Interventions are used. However, these interventions have not been systematically evaluated in the same way that CBT has, and there is a risk that patients that would have benefitted from structured CBT are undertreated.
This study is a pilot study preparing for a large multicenter study that will be conducted starting in late 2020. The investigators want to find out if an addition of an extended evaluation and possibility of treatment with guided CBT self-help can increase the treatment effects of PCBH on patient functioning and symptoms, compared to standard PCBH with a contextual assessment and brief interventions. In the process, the investigators are also conducting one of the first RCT on brief interventions. As this is a pilot study, the feasibility of implementing the study protocol in regular healthcare is also tested in order to collect high-quality data while creating minimal disturbance in the centers' ordinary routines.
PCBH has the potential to increase the quality of care for patients with mental health problems. This study is the first to step towards answering the question if the effects of brief intervention are large enough to merit large-scale implementation, and if an add-on of other brief and easily implemented treatments can increase them.
详细描述
The overarching goal of primary care is to offer all patients individualized and context-sensitive healthcare with high access and continuity. One of the reasons primary care struggles with this goal is that many patients suffer from mental health problems, while there is a lack of psychosocial resources as well as clear pathways for these patients.
Primary care behavioural health (PCBH, in Swedish IBH) is an innovative way of organizing primary care, where psychosocial resources have more and shorter visits, strive for same-day access, and have an active consulting role in the primary care team. To help patients with achieving relevant behavior changes, so called Brief Interventions are used. However, these interventions have not been systematically evaluated in the same way that CBT has, and there is a risk that patients that would have benefitted from structured CBT are undertreated.
This study is a pilot study preparing for a large multicenter study that will be conducted starting in late 2020. The investigators want to find out if an addition of an extended evaluation and possibility of treatment with guided CBT self-help can increase the treatment effects of PCBH on patient functioning and symptoms, compared to standard PCBH with a contextual assessment and brief interventions. In the process, the investigators are also conducting one of the first RCT on brief interventions. As this is a pilot study, the feasibility of implementing the study protocol in regular healthcare is also tested in order to collect high-quality data while creating minimal disturbance in the centers' ordinary routines.
Our main research questions are:
- Does an extended version of PCBH, including an additional assessment and the option of guided self-help CBT when indicated by a patient's problem profile, lead to superior patient outcomes compared to standard PCBH where a brief, contextual assessment followed by Brief Interventions is the only option? If not, can standard PCBH be shown to be non-inferior?
- Does the addition of guided self-help CBT have a negative effect on availability, reach, and cost-effectiveness compared to standard PCBH? If not, can guided self-help CBT be shown to be non-inferior to standard PCBH concerning these outcomes?
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 (Participant)
盲法说明
Patients will be informed only that they will be randomised between two different types of extended assessments, both of which are more extensive than regular healthcare. They will receive no information about the nature of the extended assessments or about different treatments following the assessments to avoid nocebo effects.
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
- •All patients from age 18 deemed to be suitable for Behavioral Health interventions, according to screening methods and/or clinical assessments made by health care personnel at the PCC, will be included. This broad criteria reflects the naturalistic setting where decisions of clinicians, rather than highly standardized criteria, are the basis for inclusion.
排除标准
- •Does not speak Swedish well enough to fill out questionnaires.
- •Is in need of emergency type care, like with suicidal ideation or behaviours, ongoing psychosis or mania.
结局指标
主要结局
WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (4 domains)
时间窗: Change during the period Pre-Week4-Week8
The four domains of Life activities, Cognition, Getting along, and Participation. In the 12-item version of the WHO Disability Assessment Schedule 2.0 (WHODAS-12) will be used as primary outcome, since these are condition-independent measures of Behavioral Health relevant everyday functioning. The scale ranges from 0 to 32 points. A lower score means better functioning. As such, a lower score is a better outcome.
次要结局
- Insomnia Severity Index 2-item (ISI-MINI-2)(Change during the period Pre-Week4-Week8-Week 52)
- Obsessive Compulsive Disorder 3-Item (OCD-3-MINI)(Change during the period Pre-Week4-Week8-Week 52)
- Total symptom index(Change during the period Pre-Week4-Week8-Week 52)
- Description of Behavioral Health Plan (PCBH) or main treatment goal and methods (shCBT) as structured note by clinician in medical record(4 weeks, 8 weeks, 52 weeks)
- WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (whole instrument)(Change during the period Pre-Week4-Week8-Week 52)
- The Alcohol Use Disorders Identification Test-Concise (AUDIT-C)(Change during the period Pre-Week4-Week8-Week 52)
- Shirom-Melamed Burnout Questionnaire 2-item (SMBQ-MINI-2)(Change during the period Pre-Week4-Week8-Week 52)
- Panic Disorder Severity Scale - Self rated 2-item (PDSS-SR-MINI-2)(Change during the period Pre-Week4-Week8-Week 52)
- Short Health Anxiety Inventory 3-item (SHAI-MINI-3)(Change during the period Pre-Week4-Week8-Week 52)
- Patient-rated perception and attitude toward care provider(4 weeks, 8 weeks)
- Patient Health Questionnaire 2-Item (PHQ-2)(Change during the period Pre-Week4-Week8-Week 52)
- Generalized Anxiety Disorder 2-Item (GAD-2)(Change during the period Pre-Week4-Week8-Week 52)
- Social Phobia Inventory - Abbreviated version (Mini-SPIN)(Change during the period Pre-Week4-Week8-Week 52)
- Pain One-item Rating(Change during the period Pre-Week4-Week8-Week 52)
- Patient recollection of plan/goal/methods, descriptions of behaviour changes made(4 weeks, 8 weeks, 52 weeks)
- Perceived Stress Scale (PSS-MINI-2)(Change during the period Pre-Week4-Week8-Week 52)
- Brunnsviken Brief Quality of Life Questionnaire(Change during the period Pre-Week4-Week8-Week 52)
- Patient-rated problem severity, Confidence in ability to change, and Helpfulness of visit(Change from visit to visit through study completion (average of 8 weeks))
- One item Clinical Global Impression - Improvement (CGI-I)(4 weeks, 8 weeks)
- Experienced negative/Adverse Events, where the worst and most probably care-induced event is more thoroughly described and rated on severity and perceived cause(4 weeks, 8 weeks, 52 weeks)
研究者
Viktor Kaldo
Professor
Linnaeus University