Neurotic DisordersNCT02257996
Effectiveness of Online Systematic Brief Psychodynamic Psychotherapy for Neurotic Disorders: Randomized Controlled Trial
A study testing Online Systematic Brief Psychodynamic Psychotherapy in people with Neurotic Disorders, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Neurotic Disorders
- What is being tested?
- Online Systematic Brief Psychodynamic Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinical Psychology Department from Institute of Psychology at University of Sao Paulo
São Paulo, São Paulo, 05508-030
Claudia CA Siqueira, MSc, +5511985885778, claudiacatao@usp.br
Marcelo N Russo, +5511992029060, mrusso@casadosinsights.com.br
About this study
Official title: 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.
Read more
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.
- Conditions
- Neurotic Disorders
- Being tested
- Online Systematic Brief Psychodynamic Psychotherapy
- Keywords
- Psychoanalytic Psychotherapy, Telepsychology, Online Therapy, Web conferencing, RCT, HIPAA
- Medical subject headings
- Neurotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Systematic Brief Psychodynamic PsychotherapyBehavioural
Systematic Adaptative Diagnosis System will be applied in both groups at two different times: pre-treatment and post-treatment
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Online Systematic Brief Psychodynamic Psychotherapy Receives: Behavioral: Online Systematic Brief Psychodynamic Psychotherapy |
| Control Group | No intervention | Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each participant will be followed, an expected average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startAug 2015
- Primary completionMay 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurotic DisordersStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Catao Alves Siqueira, University of Sao Paulo
- Investigators
- Claudia CA Siqueira, MSc, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257996
- Sponsor's protocol ID
- SBPP-1
- Status last verified
- Jan 2015
- First submitted
- 24 Sep 2014
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Online Systematic Brief Psychodynamic Psychotherapy Via HIPAA Complaint Web Conferencing on Adults With Neurotic Disorders: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02257996
- Acronym / sponsor ID
- SBPP-1
- Conditions
- Neurotic Disorders
- Keywords
- Psychoanalytic Psychotherapy, Telepsychology, Online Therapy, Web conferencing, RCT, HIPAA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Behavioral: Online Systematic Brief Psychodynamic PsychotherapyOnline Systematic Brief Psychodynamic Psychotherapy |
| Control Group | No intervention | –Waiting list |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Systematic Brief Psychodynamic PsychotherapySystematic Adaptative Diagnosis System will be applied in both groups at two different times: pre-treatment and post-treatment | Behavioural | Interventional Group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
Related trials for Neurotic Disorders
Recruiting
Digital Interventions for Relapse Prevention in Adolescence
Major Depression Disorder, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Recruiting
Effectiveness of the Group Unified Protocol for Emotional Disorders in Adults in a Public Mental Health Setting
Emotional Disorders, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Recruiting
Reward Processing and Exposure Therapy for Social Anxiety Disorder
Social Anxiety Disorder (Social Phobia), Public Speaking Anxiety
RecruitingObservational study
A Novel Blood Test as a Biomarker in Mental Health
Depression - Major Depressive Disorder, Schizophenia Disorder
Recruiting
Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders
ANXIETY DISORDERS (or Anxiety and Phobic Neuroses), Specific Phobia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia CA Siqueira, MSc principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Systematic Brief Psychodynamic Psychotherapy in people with Neurotic Disorders, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia CA Siqueira, MSc (+5511985885778, claudiacatao@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systematic Adaptive Diagnosis Scale (SADS) (time frame: Each participant will be followed, an expected average of 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2015.