Effectiveness of an Internet-based Intervention for the Treatment of Depression

NCT03093467 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2021-04-08

No results posted yet for this study

Summary

Depression is a highly prevalent disorder in Chile, generating important personal and social costs. This study aims to evaluate the effectiveness of the internet-based program ASCENSO as an adjunct intervention for the treatment of depression. ASCENSO provides information to promote patients' self-care, it monitors reported depression symptoms providing automatized feedback and provides the possibility of booking a counseling session via chat or by phone. To evaluate the effectiveness of ASCENSO, an open, evaluator-blind, prospective, parallel-group (one intervention group and one active control group) randomized controlled trial will be implemented in one mental health center in Santiago of Chile. The sample will be composed of adults initiating treatment for depression, and who have internet access. Participants will be randomly assigned to one of the two study arms. Randomization will be stratified by the number of patients´ previous episodes (dichotomized into none, 1 or more), following a permuted block randomization procedure. Patients in the experimental group (n=100) will receive the usual treatment plus access to the ASCENSO program. The control group (n=100) will only receive the usual treatment. At recruitment, months 6 and 9, patients' self-reported depression symptoms and quality of life will be assessed. Additionally, adherence to treatment in terms of patients' attendance to medical controls and psychotherapy sessions will be registered for both research groups.

Conditions

Interventions

BEHAVIORAL

ASCENSO

Internet-based program: an adjunct support and monitoring system for the treatment of depression.

DRUG

Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers.

Usual psychiatric treatment which may include drugs: antidepressant monotherapy or antidepressants in combination with anxiolytics, neuroleptics or mood stabilizers as needed, according to the psychiatric evaluation. Monthly controls during 5 months in average.

BEHAVIORAL

Psychotherapy

Usual treatment: brief psychotherapy. One session per week, a total of 9 sessions in average.

Sponsors & Collaborators

  • Psicomedica Clinical & Research Group, Chile

    collaborator UNKNOWN
  • University Hospital Heidelberg

    collaborator OTHER
  • National Fund for Research and Development in Health, Chile

    collaborator OTHER
  • Instituto Milenio para Investigación en Depresión y Personalidad

    lead OTHER

Principal Investigators

  • Álvaro E. Carrasco, PhD · Millennium institute for research on depression and personality (MIDAP)

  • Janet C. Pérez, PhD · Millennium institute for research on depression and personality (MIDAP)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-29
Primary Completion
2019-11-13
Completion
2019-11-13

Countries

  • Chile

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03093467 on ClinicalTrials.gov