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Effectiveness of Online Systematic Brief Psychodynamic Psychotherapy for Neurotic Disorders: Randomized Controlled Trial

Primary Purpose

Neurotic Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Online Systematic Brief Psychodynamic Psychotherapy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurotic Disorders focused on measuring Psychoanalytic Psychotherapy, Telepsychology, Online Therapy, Web conferencing, RCT, HIPAA

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.

Sites / Locations

  • Clinical Psychology Department from Institute of Psychology at University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional Group

Control Group

Arm Description

Online Systematic Brief Psychodynamic Psychotherapy

Waiting list

Outcomes

Primary Outcome Measures

Change in Systematic Adaptive Diagnosis Scale (SADS)
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.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2014
Last Updated
January 14, 2015
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02257996
Brief Title
Effectiveness of Online Systematic Brief Psychodynamic Psychotherapy for Neurotic Disorders: Randomized Controlled Trial
Official Title
The Effectiveness of Online Systematic Brief Psychodynamic Psychotherapy Via HIPAA Complaint Web Conferencing on Adults With Neurotic Disorders: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurotic Disorders
Keywords
Psychoanalytic Psychotherapy, Telepsychology, Online Therapy, Web conferencing, RCT, HIPAA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional Group
Arm Type
Experimental
Arm Description
Online Systematic Brief Psychodynamic Psychotherapy
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Waiting list
Intervention Type
Behavioral
Intervention Name(s)
Online Systematic Brief Psychodynamic Psychotherapy
Intervention Description
Systematic Adaptative Diagnosis System will be applied in both groups at two different times: pre-treatment and post-treatment
Primary Outcome Measure Information:
Title
Change in Systematic Adaptive Diagnosis Scale (SADS)
Description
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.
Time Frame
Each participant will be followed, an expected average of 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia CA Siqueira, MSc
Phone
+5511985885778
Email
claudiacatao@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo N Russo
Phone
+5511992029060
Email
mrusso@casadosinsights.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia CA Siqueira, MSc
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Psychology Department from Institute of Psychology at University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05508-030
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia CA Siqueira, MSc
Phone
+5511985885778
Email
claudiacatao@usp.br
First Name & Middle Initial & Last Name & Degree
Marcelo N Russo
Phone
+5511992029060
Email
mrusso@casadosinsights.com.br
First Name & Middle Initial & Last Name & Degree
Claudia CA Siqueira, MSc

12. IPD Sharing Statement

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Effectiveness of Online Systematic Brief Psychodynamic Psychotherapy for Neurotic Disorders: Randomized Controlled Trial

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