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Internet-delivered Cognitive Behavioral Treatment of Depression and Anxiety in Latin American College Students

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ClinicalTrials.gov Identifier: NCT04780542
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : April 27, 2021
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Harvard Medical School
Information provided by (Responsible Party):
Corina Benjet, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Brief Summary:
The aim is to evaluate short term and longer term treatment effects of internet-delivered cognitive behavioral therapy compared to treatment as usual for college students with anxiety and/or depression in low-middle income countries of Latin America.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Generalized Anxiety Disorder Behavioral: Yo Puedo Sentirme Bien- Clinician-Guided version Behavioral: Yo Puedo Sentirme Bien- Self-Guided version Behavioral: Treatment as usual Not Applicable

Detailed Description:

This study is designed to detect, engage, and experimentally evaluate the effects of internet-based cognitive behavior therapy (e-CBT) to treat college students in two Latin American low-middle income countries (LMICs; Colombia and Mexico) with major depressive disorder and/or generalized anxiety disorder, with or without other comorbid common mental disorders (CMDs). Detection and engagement will be based on inexpensive internet-based recruitment and administration of self-report surveys. The intervention will be based on inexpensive e-CBT to address the low resources in LMICs. The study builds on prior research by collaborators in the WHO World Mental Health (WMH) survey consortium and WMH International College Study (WMH-ICS) initiative documenting high prevalence, impairment, and unmet need for treatment of CMDs among college students around the world and significant effects of e-CBT in treating these disorders in high income countries.

First, the investigators will carry out a pragmatic clinical trial with students seeking treatment for CMDs at student clinics in universities in Colombia and Mexico. Students on waitlists for student clinic services will be offered a possibility of receiving guided or self-guided e-CBT immediately while staying on the list. 33% of the students with CMD who express interest will be randomized to guided e-CBT, another 33% to self-guided e-CBT, and the remaining 33% to treatment as usual (TAU), where the latter is defined as remaining on the waiting list. Short-term aggregate intervention effects will be assessed 90 days after randomization and longer-term effects 12 months after randomization. The investigators will then use ensemble machine learning methods to predict heterogeneity of treatment effects of e-CBT versus TAU and develop a precision treatment rule (PTR) to predict which students will respond best to which intervention. A SMART design will then be implemented in which 50% of a second cohort of students from the same sample frame (i.e., students seeking treatment for CMDs at student clinics in the participating universities) will be randomized to the treatment arm predicted to be optimal by the PTR and the other 50% to randomization across arms.

Additionally, the investigators will use outreach to recruit students into the trial who might not otherwise seek treatment from student clinics. Two procedures will be used here. In the first, students will be recruited from annual WMH-ICS internet-based mental health needs assessment surveys that will be carried out with a probability sample of students to estimate unmet need for treatment and barriers to treatment. Students who respond to these surveys and meet inclusion criteria and are not in treatment will be randomized to guided e-CBT, self-guided e-CBT, and treatment as usual in student clinics to determine if access to guided and self-guided e-CBT reduces the unmet need for treatment among students with CMDs who fail to seek treatment at student health clinics. The second will expand recruitment by sending emails to random subsamples of students notifying them of the availability of the internet-based interventions and inviting them to participate in a trial. Students that respond to this announcement will then be recruited and randomized into the same three arms as among students that participated in the annual WMH-ICS survey.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Participant recruiters will be blinded to the participant's intended treatment arm.
Primary Purpose: Treatment
Official Title: Computerized Detection and Internet-based Treatment of Common Mental Disorders Among College Students in Two Latin American LMICs
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Clinician-Guided iCBT
Both help-seeking students recruited from university clinics and non-help-seeking students recruited from needs assessment survey and outreach will receive internet delivered cognitive behavioral therapy guided by clinicians
Behavioral: Yo Puedo Sentirme Bien- Clinician-Guided version
Internet delivered Cognitive Behavioral Therapy- Guided version

Active Comparator: Treatment as usual
Help-seeking students recruited from university clinics will remain on waitlist until they receive treatment as usual. Non-help-seeking students recruited from needs assessment survey and outreach will be referred to university health clinic.
Behavioral: Treatment as usual
Waitlist until appointment and then treatment as usually provided by student clinic

Active Comparator: Self-guided iCBT
Help-seeking students recruited from university clinics will receive self-guided internet delivered cognitive behavioral therapy while on waitlist. Non-help seeking students recruited from needs assessment survey and outreach will receive the self-guided version of internet delivered cognitive behavioral therapy.
Behavioral: Yo Puedo Sentirme Bien- Self-Guided version
Internet delivered Cognitive Behavioral Therapy- Self-Guided version




Primary Outcome Measures :
  1. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 90 days ]
    Self-report measure of depressive symptoms in the prior 2 weeks. Scores range from 0 to 27 with higher scores representing greater depressive symptomatology.

  2. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 90 days ]
    Self-report measure of anxiety symptoms in the prior 2 weeks. Scores range from 0 to 21 with higher scores representing greater anxiety.

  3. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 12 months ]
    Self-report measure of depressive symptoms in the prior 2 weeks. Scores range from 0 to 27 with higher scores representing greater depressive symptomatology.

  4. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 12 months ]
    Self-report measure of anxiety symptoms in the prior 2 weeks. Scores range from 0 to 21 with higher scores representing greater anxiety.


Secondary Outcome Measures :
  1. Sheehan Disability Scale (SDS) [ Time Frame: 90 days ]
    Self-report measure of impairment due to mental health in four life areas in the prior 2 weeks. Scores in each area range from 0 to 10 with higher scores reflecting greater impairment.

  2. Sheehan Disability Scale (SDS) [ Time Frame: 12 months ]
    Self-report measure of impairment due to mental health in four life areas in the prior 2 weeks. Scores in each area range from 0 to 10 with higher scores reflecting greater impairment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

At least 18 years of age, screens positive for major depressive disorder and/or generalized anxiety disorder, student enrolled in one of the participating universities

Exclusion Criteria:

Screens positive for bipolar disorder, screens positive for psychosis, active suicidality


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780542


Contacts
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Contact: Corina Benjet, PhD +525541605332 cbenjet@gmail.com

Locations
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Colombia
Universidad Cooperativa de Colombia Recruiting
Medellín, Colombia
Contact: Nayib Ester Carrasco Tapias, PhD       nayib.carrasco@ucc.edu.co   
Mexico
Universidad Nacional Autonoma de México Recruiting
Mexico City, Mexico
Contact: Benjamin Guerrero Lopez, MD       jefaturadpsm.unam@gmail.com   
Sponsors and Collaborators
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
National Institute of Mental Health (NIMH)
Harvard Medical School
Investigators
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Principal Investigator: Corina Benjet, PhD Instituto Nacional de Psiquiatría
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Responsible Party: Corina Benjet, Principal Investigator, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
ClinicalTrials.gov Identifier: NCT04780542    
Other Study ID Numbers: EP20142
R01MH120648-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: First, we will document and make available all imputations, weights, and constructed variables used in our analyses. Second, we will host a project webinars to present an overview of the data and answer questions. The webinars will be widely advertised in list serves, including any such sites recommended by NIMH, as well as to NIH training programs. An English version of the webinars will be hosted by the US collaborators. A Spanish version will be hosted by the Mexican collaborators. Third, we will set up and man a project Q&A web site in which public users can ask questions and get answers about issues involved in working with the data. Again, the site will be both in English and Spanish. Fourth, we will gather up written versions of all questions asked by public users along with our written response (including any documentation or computer files sent along with these answers) and post these on the website in both English and Spanish as reference documents for future public users.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Data will become available in Year 5, once trials are concluded
Access Criteria: By written request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corina Benjet, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente:
iCBT
Latin America
College Students
Depression
Anxiety
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mental Disorders
Mood Disorders