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

Sponsor
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente (Other)
Overall Status
Recruiting
CT.gov ID
NCT04780542
Collaborator
National Institute of Mental Health (NIMH) (NIH), Harvard Medical School (HMS and HSDM) (Other)
1,500
2
3
51
750
14.7

Study Details

Study Description

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
  • Behavioral: Yo Puedo Sentirme Bien- Clinician-Guided version
  • Behavioral: Yo Puedo Sentirme Bien- Self-Guided version
  • Behavioral: Treatment as usual
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 1, 2021
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Patient Health Questionnaire-9 (PHQ-9) [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) [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) [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) [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad Cooperativa de Colombia Medellín Colombia
2 Universidad Nacional Autonoma de México Mexico City Mexico

Sponsors and Collaborators

  • Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
  • National Institute of Mental Health (NIMH)
  • Harvard Medical School (HMS and HSDM)

Investigators

  • Principal Investigator: Corina Benjet, PhD, Instituto Nacional de Psiquiatría

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
First Posted:
Mar 3, 2021
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Corina Benjet, Principal Investigator, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2022