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临床试验/NCT02257996
NCT02257996Unknown不适用

The Effectiveness of Online Systematic Brief Psychodynamic Psychotherapy Via HIPAA Complaint Web Conferencing on Adults With Neurotic Disorders: a Randomized Controlled Trial

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
32
试验地点
2
主要终点
Change in Systematic Adaptive Diagnosis Scale (SADS)

研究概览

简要总结

Objective: To evaluate the effectiveness of online systematic brief psychodynamic psychotherapy (SBPP) via HIPAA compliant web conferencing on adults with neurotic disorders.

Design: Randomized controlled trial. Single blind.

Setting: Internet users in the community, in São Paulo, Brazil.

Participants: Thirty-two adults will be randomly allocated to a group will receive online systematic brief psychodynamic psychotherapy (n=16), or a waiting list group (n=16).

Method: Systematic adaptative diagnosis system will be applied in both groups at pre-treatment and post-treatment (or post-waiting list). Assessment will be a comparison of the adaptative diagnosis evolution between groups.

Primary Outcomes: The subjects treated with online brief systematic psychodynamic psychotherapy will present an increase in their adaptative efficacy measured by systematic adaptative diagnosis scale (SADS) in comparison to the waiting list group, when contrasting their initial and final adaptative diagnostics.

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 (Participant)

入排标准

年龄范围
22 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Residents in Sao Paulo city,
  • Graduation complete or in course,
  • Fluent Portuguese,
  • Basic skills on english language,
  • If in psychiatric treatment, must be under treatment with stable dosage of psychiatric medication for at least 6 months,
  • Participants with diagnosis of neurotic disorders (F03.650),
  • Motivation for the therapeutic process,
  • Availability for 4 months of psychotherapy,
  • A personal computer (with an IP address), a web camera, a microphone, access to a 1 Mbps internet connection and specific computer configuration to access the Secure Psychotherapy Virtual Environment,
  • Basic knowledge of elementary internet tools,
  • A justified reason that impedes a in person psychotherapy, such as the ones below:
  • Lack of financial resources,
  • Frequent change of address due to work reasons,
  • Mobility restrictions related to accidents, illnesses or physical deficiencies,
  • Inability to arrive for psychotherapy appointments due to urban chaos.

排除标准

  • Participants that present:
  • a schizophrenia diagnostic or any other severe mental illness,
  • drug and alcohol dependence that are in abstinence from substance abuse,
  • untreated diagnosis of illnesses that may cause emotional imbalance, such as thyroid malfunction,
  • Participants that are undergoing a therapeutic process during the time of the research,
  • Individuals with both suicidal ideation and clear intent and need emergency treatment,
  • Participants do not possess the characteristics needed to be included in the sample or are bearers of deficiencies that may compromise the treatment mediated by a computer.

结局指标

主要结局

Change in Systematic Adaptive Diagnosis Scale (SADS)

时间窗: Each participant will be followed, an expected average of 3 months.

Participants of interventional group will be followed for the duration of therapeutic process, an expected average of 3 months. Participants of control group will be followed after waiting-list period, an expected average of 3 months.

次要结局

未报告次要终点

研究者

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

Claudia Catao Alves Siqueira

PhD researcher

University of Sao Paulo

研究点 (2)

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