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

Neurotic Disorders Clinical 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02257996
• Other study ID #: SBPP-1
• Status: Not yet recruiting
• Phase: N/A
• First received: September 24, 2014
• Last updated: January 14, 2015
• Start date: August 2015
• Est. completion date: October 2017

Study information

• Verified date: January 2015
• Source: University of Sao Paulo
• Contact: Claudia CA Siqueira, MSc
• Phone: +5511985885778
• Email: claudiacatao[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: October 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neurotic Disorders

Intervention

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

Locations

Country	Name	City	State
Brazil	Clinical Psychology Department from Institute of Psychology at University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No