Increasing Treatment Response Rates in Depressed Adolescents Via Feedback-Informed Internet-Delivered Psychodynamic Therapy - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Response to treatment according to the proportion improvement method
研究概览
简要总结
The overarching research project aims to evaluate of an internet-delivered affect-focused psychodynamic treatment (IPDT) for adolescents aged 15-19 with depression. The previous study was a non-inferiority randomized controlled trial (RCT) comparing IPDT with internet-delivered cognitive behavior therapy (ICBT). The results showed that IPDT and ICBT had similar effects. Adolescents in both treatments showed large improvements in both depression and other outcome measures. Online psychological treatment is also known as guided self-help, where the participant reads texts and performs exercises on their own, with the support of an online therapist.
The planned study is an RCT to investigate the effect of therapist feedback and customized treatment for adolescents at risk of not being helped by IPDT. The study builds on analyses of predicted treatment trajectories in the project's previous study. Based on these analyses, algorithms have been developed that identify which young people who, after three weeks of treatment, are at risk of not getting a good outcome from the treatment. In the present study, 240 young people aged 15-19 with major depression will begin IPDT. After three weeks of treatment, the course of the treatment is analyzed using the algorithm and the young people who are at risk of not having a good outcome are identified. These adolescents are randomized to either continue unchanged treatment or to receive detailed therapist feedback on the adolescent's treatment prognosis and instructions to adapt the treatment in consultation with the individual adolescent. The IPDT treatment consists of eight modules and treatment duration is ten weeks. The study evaluates the effect of the treatment on depression and other variables such as anxiety symptoms, emotion regulation and self-image.
The project's previous studies have shown that IPDT is an effective treatment that can be offered to adolescents with depression. The planned study can show whether the outcome of IPDT can be further improved by paying attention to adolescents with poorer treatment progress and adapting the treatment more to their needs.
详细描述
Study goals and objectives This is the third study in a larger project, the ERiCA project. The overarching aim of the project is to develop and evaluate cost-effective internet-delivered treatments for adolescent depression. The present study will try an adaptive treatment strategy with the goal of increasing treatment response rates. Based on data from our previous large non-inferiority trial (Mechler et al., 2022), an algorithm have been developed for prediction of treatment non-response at week 3. The specific objective of the present trial is to evaluate whether identifying participants at risk of non-response and then adapting treatment during the course of treatment can reduce risk of non-response. Additional goals are to investigate process factors that predict and mediate outcome for the treatment in order to learn more about mechanisms and processes of change and no-change.
Primary research question Research question 1: Can adapted treatment reduce risk of non-response for identified at-risk-participants in IPDT? Hypothesis 1: Adapted treatment will decrease risk of non-response in IPDT in comparison with non-adaptive treatment strategy.
Research question 2: Can non-response be accurately predicted? Hypothesis 2: Non-response will be accurately predicted using an algorithm at week 3.
Secondary research questions 3: Are there patient factors that affect efficacy of the treatment program (i.e. predictors/moderators) and the adapted treatment program? 4: Are there within-treatment factors that affect efficacy of the program and adaptation (mediators)? 5. Are there differences in the effects on the severity of depressive symptoms, anxiety symptoms, capacity for mentalized affectivity, emotion regulation, fear of negative emotions, defense mechanisms, and self-concept when comparing adaptive treatment strategies to non-adaptive?
Study Design The trial is a randomized controlled trial (RCT). All eligible participants (n = 240) will be entered into IPDT. At week 3 in treatment, participants at risk of non-response will be identified using our open-source algorithm. Identified participants at risk will be randomized to either adapted treatment or continued IPDT as usual.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents 15-19 years of age suffering from mild to moderate major depressive disorder (MDD) according to DSM-5 as established through a diagnostic interview (MINI 7.0 Sheehan et al., 1998). MDD should be the primary diagnosis. Participants must have access to a computer/smart phone/tablet with internet connection, and be able to read, write and speak Swedish without the aid of an interpreter.
排除标准
- •Exclusion criteria include risk of suicidality and/or earlier suicide attempts, partaking in other psychological treatment, psychotropic medication not stable since at least one month (and with no planned dose adjustments), other primary diagnoses, and current fulfilment of any of the following diagnoses: any psychotic disorder, bipolar I/II disorder, antisocial personality disorder, and autism-spectrum disorder. Comorbid drug- or alcohol abuse will also be exclusion criteria.
结局指标
主要结局
Response to treatment according to the proportion improvement method
时间窗: Pre-treatment and after 10 weeks (end of treatment)
treatment response is defined as over 50% improvement within the pathological range and at least 25% improvement within the total range on the Quick Inventory of Depressive Symptomatology in Adolescents Self-Rated (QIDS-A17-SR)
次要结局
- Defence mechanism functioning(Pre-treatment and after 10 weeks (end of treatment))
- Self-concept and identity(Pre-treatment, after 10 weeks (end of treatment), one-year follow-up)
- Severity of depressive symptoms(Pre-treatment, weekly during treatment, after 10 weeks (end of treatment) and one-year follow-up)
- Anxiety symptoms(Pre-treatment, post-treatment, one-year follow-up)
- Difficulties in emotion regulation(Pre-treatment and after 10 weeks (end of treatment))
研究者
Björn Philips
Professor
Stockholm University