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
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
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