Implementation of Internet-Based Psychotherapy for OCD in Primary Health Care in Two Cities in the State of São Paulo

NCT06658756 | Not Yet Recruiting DMC

• 1 other identifier: 74835123.7.0000.0068
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this study is to assess the implementation of Internet-based Cognitive Behavioral Therapy (I-CBT) treatment in a Brazilian sample. Researchers will compare 140 participants (70 with I-CBT and 70 in usual care to see if the treatment is feasible. Participants will undergo online treatment for OCD, lasting 10 to 14 weeks.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• Y-BOCS

  Yale Brown Obsessive-Compulsive Scale. (range from 0 to 40). The lower the score on the scale, the lower the severity or the greater the reduction of symptoms.

  From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment

Secondary Outcomes (2)

• PHQ-9

  From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment

• GAD-7

  From enrollment to the end of treatment at 10 weeks. 3 and 12 months after end of treatment

Study Arms (2)

I-CBT

EXPERIMENTAL

Internet cognitive-behavioral therapy

Behavioral: internet-CBT

TU

NO INTERVENTION

Treatment as Usual

Interventions

internet-CBT BEHAVIORAL

10 modules on line of I-CBT for OCD

I-CBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary diagnosis of OCD according to the DSM-5 (American Psychiatric Association, 2013);
• internet access.

You may not qualify if:

• acute suicide risk, assessed by a positive response (1, 2 or 3) to item 9 of the PHQ-9 and considered serious (suicidal imminence) in the suicide risk assessment protocol (S-RAP);
• psychotic symptoms;
• dependence on alcohol or other known psychoactive substances;
• recent bereavement;
• significant cognitive impairment;
• terminal illness for clinical reasons (based on their knowledge of the patient);
• illiterate patients or those unable to read (for example, due to severe dyslexia or visual impairment);
• patients without access to the internet or an electronic device to access the treatment platform.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (3)

Basic Health System

Indaiatuba, São Paulo, Brazil

Location

University of Sao Paulo General Hospital.

São Paulo, São Paulo, 05403903, Brazil

Location

University of Sao Paulo General Hospital

São Paulo, São Paulo, 05403903, Brazil

Location

Related Publications (21)

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MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a pragmatic clinical treatment, randomized-controlled, parallel, open, two-arm trial.

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: October 26, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will me available starting after publication.
• Access Criteria: Upon request from others researchers.

Locations

BR (3)