NCT02257996

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

1.8 years

First QC Date

September 24, 2014

Last Update Submit

January 14, 2015

Conditions

Keywords

Psychoanalytic PsychotherapyTelepsychologyOnline TherapyWeb conferencingRCTHIPAA

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Study Arms (2)

Interventional Group

EXPERIMENTAL

Online Systematic Brief Psychodynamic Psychotherapy

Behavioral: Online Systematic Brief Psychodynamic Psychotherapy

Control Group

NO INTERVENTION

Waiting list

Interventions

Systematic Adaptative Diagnosis System will be applied in both groups at two different times: pre-treatment and post-treatment

Interventional Group

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 05508-030, Brazil

Location

MeSH Terms

Conditions

Neurotic Disorders

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Claudia CA Siqueira, MSc

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia CA Siqueira, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD researcher

Study Record Dates

First Submitted

September 24, 2014

First Posted

October 7, 2014

Study Start

August 1, 2015

Primary Completion

May 1, 2017

Study Completion

October 1, 2017

Last Updated

January 15, 2015

Record last verified: 2015-01

Locations