Single-Arm Feasibility Study of a Transdiagnostic Course for Common Mental Health Problems in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 4
- 主要终点
- Overall Satisfaction With Treatment
研究概览
简要总结
This study investigates the feasibility of a transdiagnostic course that is intended to work for a large variety of patient groups with clinically significant depression or anxiety in primary care. This is a prospective single-group study where 68 adults with clinically significant symptoms of depression or general anxiety, and up to 25 adults with subclinical symptoms, attend up to 6 weekly structured large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing. If necessary, due to the covid-19 pandemic, the course will be held online.
详细描述
Background:
Depression and the common anxiety disorders are highly prevalent and associated with disability and reduced quality of life. There is reason to believe that the majority of these patients are found in primary care. Official Swedish guidelines dictate that primary care clinics are responsible for treating mild to moderate cases, but access to treatment is limited. Transdiagnostic psychological interventions have been found to be efficacious for anxiety and mood disorders, and require a relatively rudimentary pre-treatment assessment. A large-group transdiagnostic course based on cognitive-behavioral principles may constitute an effective use of limited resources to improve access to treatment, and offer a sufficiently effective intervention, for most primary care patients with mild to moderate mental health problems.
Aim:
To investigate the feasibility and preliminary efficacy of a large-group transdiagnostic intervention for depression and clinically significant anxiety in Swedish primary care.
Design:
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
盲法说明
Psychological intervention, self-report outcomes
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
- •At least 8 points on the GAD-7 or 10 points on the PHQ-9 (N=68; up to 25 subclinical participants may also take part in the study)
- •At least 18 years old
排除标准
- •At least one severe mental health problem such as suicidal ideation, a bipolar disorder, or psychosis
- •Non-stable antidepressant medication (dosage changed during the past 6 weeks)
- •Planned absence for 2 weeks or more of the intended treatment period
结局指标
主要结局
Overall Satisfaction With Treatment
时间窗: Post-course assessment (immediately after the course, completed within 45 days)
Preregistered target: mean Client Satisfaction Questionnaire (CSQ-8) score of at least 22. Theoretical range: 8-32, higher score indicates higher satisfaction. This sum score is based on 8 items, each scored 1-4. The original preregistered range of 7-28 was an erratum.
次要结局
- Adherence Operationalized as the Average Number of Attended Lectures(From week 1 to week 6)
- Number of Participants With Clinically Significant Improvement in Symptoms of Depression(Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days))
- Number of Participants With Clinically Significant Improvement in General Anxiety(Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days))
- Number of Participants With Problematic Lifestyle Behaviors(Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days))
- Number of Adverse Events(From week 1 to week 6)
- Percentage of Patients in Need of Additional Clinical Intervention(Post-course assessment (within 45 days after the course))
- Change in Mean Symptoms of Depression From Pre- to Post-Course Assessment(Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days))
- Change in Mean General Anxiety From Pre- to Post-Course Assessment(Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days))
- Change in Mean Perceived Stress From Pre- to Post-Course Assessment(Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days))
- Change in Mean Disability From Pre- to Post-Course Assessment(Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days))
研究者
Erland Axelsson
Principal Investigator
Karolinska Institutet