Internet-based Affect Focused Psychodynamic Therapy for Neuroticism: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Neuroticism scale of the Maples et al (2014) IPIP NEO PI 120 Item representation
研究概览
简要总结
The purpose of the study is to investigate if internet delivered affect-focused psychodynamic therapy (IPDT) leads to lowered levels of trait neuroticism compared to a wait-list control condition. The target group is adults (18+) who experience mild to moderate symptoms of anxiety and/or depression. The IPDT treatment consists of 8 modules that the participants will work with for 9 weeks, with therapist support. Participants will be recruited in Sweden with nationwide recruitment.
详细描述
This study is a randomized controlled trial with the aim to investigate if IPDT leads to lowered levels of trait neuroticism. Participants will either be randomized to the treatment which is based on Affect Phobia Therapy or to a wait-list control. Participants will have weekly contact with a therapist who will provide feedback and support.
Primary outcome measure is trait neuroticism (measured on the 24-Item Neuroticism scale of the IPIP-NEO-120). Secondary outcome measures will include measures of anxiety, depression, quality of life, emotion regulation, and defense mechanism adaptiveness. Emotion regulation and short measure of anxiety and depressive symptoms will be collected weekly throughout the treatment period. Pre-treatment measurement, post-treatment measurement, weekly measure, and one-year follow up is planned to be collected through an online survey.
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
- •Score 5 points or more on either the PHQ-9 or GAD-7
- •18 years or older
- •Ability to speak, read and write in Swedish
- •Have access to the internet and a smartphone, computer or other device
排除标准
- •Severe psychiatric or somatic illness that makes participation difficult or impossible
- •Ongoing addiction
- •Acute suicidality
- •Other ongoing psychological treatment
- •Recent (within the latest month) changes in the dose of psychotropic medication or planned change of dose during the treatment weeks
结局指标
主要结局
Neuroticism scale of the Maples et al (2014) IPIP NEO PI 120 Item representation
时间窗: Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.
Measure of trait neuroticism. Consists of 24 items. Each item is scored from 0-4 with a total range of 0-96. A higher score reflects a higher level of trait neuroticism.
次要结局
- Eysenck Personality Questionnaire Revised - Shortform (EPQR-S)(Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.)
- Patient Health Questionnaire-9(Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.)
- Generalized Anxiety Disorder-7(Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.)
- Brunnsviken Brief Quality of life scale(Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.)
- Difficulties in Emotion Regulation Scale-16(Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination. Will be measured on a weekly basis during the 9 weeks of the intervention period.)
- Defense Mechanism Rating Scale - Self Report 30(Change between baseline, end of treatment after nine weeks and follow-up at 12 months after treatment termination.)
- Patient Health Questionnaire - 4(Change between baseline, end of treatment after nine weeks. Will be measured on a weekly basis during the intervention.)
研究者
Gerhard Andersson
Professor
Linkoeping University