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

January 14, 2015 updated by: Claudia Catao Alves Siqueira, University of Sao Paulo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05508-030
        • Clinical Psychology Department from Institute of Psychology at University of Sao Paulo
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claudia CA Siqueira, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Waiting list
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Each participant will be followed, an expected average of 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Claudia CA Siqueira, MSc, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (Estimate)

October 7, 2014

Study Record Updates

Last Update Posted (Estimate)

January 15, 2015

Last Update Submitted That Met QC Criteria

January 14, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBPP-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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