跳至主要内容
临床试验/NCT06749392
NCT06749392招募中不适用

An Individual-specific Understanding of How Synchrony Becomes Curative

University of Haifa2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
78
试验地点
2
主要终点
Weekly change in Hamilton rating scale for depression (HRSD)

研究概览

简要总结

This study aims to establish synchrony as an individual-specific mechanism of therapeutic change and offers novel insights into the mechanisms of curative interpersonal processes. The study identifies individual-specific trait-like synchrony signature and investigates the associations between synchrony signature, the individual's trait-like characteristics, and mental health, among participants diagnosed with Major Depressive Disorder. The study further investigates how deterministic the trait-like synchrony signature is by identifying for whom, how, and when changes are anticipated. Additionally, it examines whether synchrony signature transfers to relationships with the therapist, whether and how it changes throughout treatment, and whether such potential changes are associated with improvements in mental health. Synchrony is recognized as a key driver of collaborative, affiliative, and curative relationships. While its potential role in improving mental health through interpersonal relationships has sparked growing interest, particularly in psychotherapy, the field is at a crossroads, with mixed findings challenging the widespread theoretical assumption that "more synchrony is better." This study introduces a personalized framework that emphasizes individual-specific synchrony signatures, shifting from generalized assumptions to tailored understanding and interventions. The study explores how synchrony can transform relationships into curative ones by leveraging individual-tailored changes in synchrony signatures in psychotherapy. The potential impact is vast. Tailoring synchrony to individual-specific signatures represents a paradigm shift from a one-size-fits-all approach to personalized interventions. This personalized framework could revolutionize mental health care by facilitating the development of targeted strategies that enhance treatment outcomes.

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
Double (Investigator, Outcomes Assessor)

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

入选标准

  • Current major depressive disorder based on the Diagnostic and Statistical Manual of Mental Disorders-5, and scores above 14 on the 17-item Hamilton rating scale for depression at two consecutive assessments, one week apart.
  • For participants using psychiatric medication, the dosage must be stable for at least three months before the beginning of the study, and they will be asked to maintain stable dosage during the treatment
  • Age between 18 and 65 years
  • Hebrew language proficiency
  • Provision of written informed consent.

排除标准

  • Current risk of suicide or self-harm
  • Current substance abuse disorders
  • Current or past schizophrenia or psychosis, bipolar disorder, or severe eating disorder requiring medical monitoring
  • History of organic mental disease
  • Currently in psychotherapy

结局指标

主要结局

Weekly change in Hamilton rating scale for depression (HRSD)

时间窗: Measured at baseline and every week for 16 weeks of treatment

A 17-item clinically administered measure assessing the severity of depression. Each item is rated on a scale ranging from 0 (don't have) to 4 (sever) or 0 (don't have) to 2 (sever). The total score ranges between 0 and 52, where higher scores indicate worse outcome.

次要结局

  • Weekly change in Beck Depression Inventory (BDI)(Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year.)
  • Weekly change in Outcome Questionnaire (OQ)(Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year.)
  • Trajectories of change in Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)(Measured at baseline, six times during the treatment (weeks 1, 2, 4, 8, 12, 16), then once a month for four months and follow up after a year.)
  • Experiences in Close Relationships Questionnaire (ECR)(Measured at baseline, six times during the treatment (weeks 1, 2, 4, 8, 12, 16), then once a month for four months and follow up after a year.)
  • Trajectories of change in Inventory of Interpersonal Problems (IIP-32)(Measured at baseline, six times during the treatment (weeks 1, 2, 4, 8, 12, 16), then once a month for four months and follow up after a year.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sigal Zilcha Mano

Full professor

University of Haifa

研究点 (2)

Loading locations...

相似试验