Development and Clinical Trial of a Transdiagnostic Single-session Treatment for Primary Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Mindfulness post-treatment
研究概览
简要总结
The goal of this clinical trial is to test a single session treatment program in primary care patients with anxiety and/or depression and/or stress-related issues. The main questions it aims to answer is:
- Will the transdiagnostic treatment program decrease symptoms of depression/anxiety/stress?
- Will the transdiagnostic treatment program decrease transdiagnostic risk factors?
- Will the transdiagnostic treatment program decrease the measured risk factors equally?
- Will the transdiagnostic treatment program impact patients with anxiety, depression or stress disorders equally?
- Will the transdiagnostic treatment program have long term (6 months post-treatment) effect on transdiagnostic risk factors?
- Will the transdiagnostic treatment program have long term (6 months post-treatment) effect on anxiety, depression, or stress-symptoms?
- Have the participants been able to generalize the skills taught in the program(qualitative)?
- Within group that were treated with single-session treatment and recieved additional care before follow-up, was there a difference in outcome?
详细描述
The study investigates the effect of a single-session, 4 hour, transdiagnostic treatment for primary care patientst with depression, anxiety or stress.
The treatment includes, interoceptive exposure, behavioral activation, mindfulness, defusion and psycho-education about emotions.
The study is conducted in a clinical setting in northern sweden and follows up results at 3 weeks and 6 months post treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the criteria for anxiety, mood disorder, or stress diagnosis
- •Symptoms are mild to moderate in severity
排除标准
- •Already in ongoing psychotherapy
- •Within a month commenced pharmaceutical treatment that will likely impact mood or psychological functioning and is not deemed to be on a stable dose
- •Has a comorbid personality disorder
- •Has a risk of suicide deemed other than low
- •Has other severe psychological disorders outside the scope of primary care
- •Is in a severely stressful social situation deemed incompatible with psychotherapy
结局指标
主要结局
Mindfulness post-treatment
时间窗: 3 weeks post-treatment
Measured using FFMQ, mindfulness
Alexithymia post-treatment
时间窗: 3 weeks post-treatment
Measured using TAS-20, mindfulness
Generalization
时间窗: 6 months post-treatment
Qualitative interview with a few selected patients to review their experience of the treatment, its effectiveness and their ability to use the techniques taught.
Anxiety, Depression and Stress symptoms post-treatment
时间窗: 3 weeks post-treatment
Measured using DASS-21
Anxiety sensitivity post-treatment
时间窗: 3 weeks post-treatment
Measured using BSQ, fear of bodily sensations related to anxiety
Experiential avoidance post-treatment
时间窗: 3 weeks post-treatment
Measured using AFQ-Y8, psychological flexibility
Experiential avoidance follow-up
时间窗: 6 months post-treatment
Measured using AFQ-Y8, psychological flexibility
Alexithymia follow-up
时间窗: 6 months post-treatment
Measured using TAS-20, mindfulness
Anxiety, Depression and Stress symptoms follow-up
时间窗: 6 months post-treatment
Measured using DASS-21
Mindfulness follow-up
时间窗: 6 months post-treatment
Measured using FFMQ, mindfulness
Anxiety sensitivity follow-up
时间窗: 6 months post-treatment
Measured using BSQ, fear of bodily sensations related to anxiety
次要结局
- Additional treatment(6 months post-treatment)
研究者
John Näsling
Lic. psychologist / Doctoral student
Luleå Tekniska Universitet