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

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ClinicalTrials.gov Identifier: NCT02257996
Recruitment Status : Unknown
Verified January 2015 by Claudia Catao Alves Siqueira, University of Sao Paulo.
Recruitment status was:  Not yet recruiting
First Posted : October 7, 2014
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
Claudia Catao Alves Siqueira, University of Sao Paulo

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.


Condition or disease Intervention/treatment Phase
Neurotic Disorders Behavioral: Online Systematic Brief Psychodynamic Psychotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : August 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : October 2017

Arm Intervention/treatment
Experimental: Interventional Group
Online Systematic Brief Psychodynamic Psychotherapy
Behavioral: Online Systematic Brief Psychodynamic Psychotherapy
Systematic Adaptative Diagnosis System will be applied in both groups at two different times: pre-treatment and post-treatment

No Intervention: Control Group
Waiting list



Primary Outcome Measures :
  1. Change in Systematic Adaptive Diagnosis Scale (SADS) [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02257996


Contacts
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Contact: Claudia CA Siqueira, MSc +5511985885778 claudiacatao@usp.br
Contact: Marcelo N Russo +5511992029060 mrusso@casadosinsights.com.br

Locations
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Brazil
Clinical Psychology Department from Institute of Psychology at University of Sao Paulo Not yet recruiting
Sao Paulo, Brazil, 05508-030
Contact: Claudia CA Siqueira, MSc    +5511985885778    claudiacatao@usp.br   
Contact: Marcelo N Russo    +5511992029060    mrusso@casadosinsights.com.br   
Principal Investigator: Claudia CA Siqueira, MSc         
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Claudia CA Siqueira, MSc University of Sao Paulo

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Responsible Party: Claudia Catao Alves Siqueira, PhD researcher, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02257996     History of Changes
Other Study ID Numbers: SBPP-1
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: January 2015

Keywords provided by Claudia Catao Alves Siqueira, University of Sao Paulo:
Psychoanalytic Psychotherapy
Telepsychology
Online Therapy
Web conferencing
RCT
HIPAA

Additional relevant MeSH terms:
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Disease
Neurotic Disorders
Pathologic Processes
Anxiety Disorders
Mental Disorders