Veränderungen Dynamischer Symptom-Netzwerke Unter Pharmakologischer, Psychotherapeutischer Und Kombinierter Behandlung Bei Depression (DYNDET)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Structure of symptom networks via multilevel vector autoregressive modeling (mlVAR)
研究概览
简要总结
This study investigates how antidepressant pharmacotherapy, cognitive-behavioral therapy, or their combination modulate the temporal dynamics and connectivity of depressive symptom networks. Using intensive longitudinal ecological momentary assessment data, the trial examines treatment-specific changes in symptom interactions.
By applying network-based analytic approaches, the study aims to elucidate differential and potentially complementary mechanisms of change across treatment modalities. Findings may contribute to more informed and individualized treatment strategies for major depressive disorder.
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 (Outcomes Assessor)
盲法说明
Due to the nature of the interventions, full blinding is not feasible. Participants are aware of their assigned treatment condition, as the interventions differ in format (e.g., pharmacotherapy versus group CBT). Similarly, therapists and prescribing physicians are not blinded. However, clinical outcome assessments, specifically structured interviews such as the HAM-D, are conducted by trained raters who remain blinded to group allocation wherever possible. To reduce analytical bias, data analysis will be conducted on pseudonymized datasets, with group identifiers masked during preprocessing and statistical modeling stages (Schulz et al., 2010).
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Depressive disorder (mild to moderate symptom severity)
- •18-65 years
- •must own a smartphone with internet access
排除标准
- •severe depressive episode
- •acute suicidality,
- •bipolar disorder,
- •substance use disorder
- •psychotic depression
- •severe medical or neurological illness
- •insufficient german language skills
- •concurrent psychotherapeutic treatment
- •conditions that may interfere with fMRI
结局指标
主要结局
Structure of symptom networks via multilevel vector autoregressive modeling (mlVAR)
时间窗: From Baseline (2 weeks) to immediately Post-Treatment (11 weeks)
Planned network intervention analyses will focus on intervention-specific effects at the symptom-network level. We will describe whether each of the three interventions shows differential direct associations with specific depressive symptoms or processes, operationalized as edges between intervention indicators and symptom/process nodes. We will also examine whether the interventions differ in their pattern of indirect associations within the network, that is, whether changes in some symptoms appear to be associated with downstream changes in other symptoms or processes. In addition, we will compare centrality metrics of depressive symptoms across interventions and over time.
次要结局
- Hamilton rating scale for depression (HAM-D)(From Inclusion to immediately Post-Treatment (11 weeks))
- Montgomery-Åsberg Depression Rating Scale (MADRS)(From Inclusion to immediately Post-Treatment (11 weeks))
- The Inventory of Depressive Symptomatology clinician (IDS-C)(From Inclusion to immediately Post-Treatment (11 weeks))
- Social and Occupational Functioning Assessment Scale (SOFAS)(Immediately at Inclusion)
- Positive and Negative Affect Schedule - Short Form (PANAS-SF)(From Inclusion to immediately Mid-Treatment (7 weeks))
- Perseverative Thinking Questionnaire (PTQ)(From Inclusion to immediately Mid-Treatment (7 weeks))
- The Acceptance and Action Questionnaire (AAQ-2)(From Inclusion to immediately Mid-Treatment (7 weeks))
- Fragebogen zur sozialen Unterstützung (F-SozU)(From Inclusion to immediately Mid-Treatment (7 weeks))
- Couples Satisafction Index (CSI-4)(From Inclusion to immediately Mid-Treatment (7 weeks))
- Perceived Deficits Questionnaire - Depression (PDQ-D)(From Inclusion to immediately Mid-Treatment (7 weeks))
研究者
Prof. Dr. Ulrich Stangier
Goethe Research Professorship
Goethe University