An interventional study of ASCENSO and Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers. in Depression, sponsored by Instituto Milenio para Investigación en Depresión y Personalidad. Completed at 1 site in Chile. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by Instituto Milenio para Investigación en Depresión y Personalidad · Not applicable, Interventional, and Treatment
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.
The public health system has established policies and priorities to provide access to depression treatment and to improve the quality of those services. The acknowledgment of the complexity and chronicity of the disorder has motivated the design and implementation of comprehensive disease management strategies for depression. There are experiences that show that information technologies can help to optimize the management of depression. If ASCENSO is effective, it could be a useful resource to include to the mental health services for depression in Chile.
The components of the ASCENSO program are:
Emergency. Standard Information on what to do and who to contact in a crisis situation.
Online or phone counseling. Patients can schedule a 30-minute session with a psychologist, which is conducted in a private text chatroom or over the phone.
Monitoring. Patients receive a bi-weekly email with a link to the monitoring questionnaire and automatized tailored feedback message. If a participant reports severe impairment, the ASCENSO administrator receives an alert notification and then contacts the patient.
Self-care information and blog. Web pages with basic information about depression and self-care recommendations.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 167 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →This is the only study on the registry with Instituto Milenio para Investigación en Depresión y Personalidad as lead sponsor.
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Exclusion Criteria:
Patients will be evaluated using the MINI International Neuropsychiatric interview, Spanish for Chile Translation Version 6.0.0.
Participants receive psychiatric treatment and psychotherapy as usual. In addition, participants have access to the internet-based program ASCENSO: an adjunct support and monitoring system for the treatment of depression.
Behavioral: ASCENSO · Drug: Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers. · Behavioral: Psychotherapy
Patients receive psychiatric treatment and psychotherapy as usual.
Drug: Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers. · Behavioral: Psychotherapy
Internet-based program: an adjunct support and monitoring system for the treatment of depression.
Also known as: Internet-based program
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.
Also known as: Psychiatric treatment
Usual treatment: brief psychotherapy. One session per week, a total of 9 sessions in average.
Change in depressivity assessed with the Beck's Depression Inventory I (BDI-I)
Beck's Depression Inventory I (BDI-I) total score (score range 0 - 63)
Time frame: Baseline, months 6 and 9.
Change in quality of life change assessed with the EuroQol/EQ-5D
EuroQol/EQ-5D (EQ-index range 0 - 1)
Time frame: Baseline, months 6 and 9.
Number of attended and missed treatment appointments
Adherence to treatment in terms of patients' attendance to medical controls and psychotherapy sessions.
Time frame: Months 6 and 9.
Number of patients that dropout from treatment
Number of patients that dropout from psychiatric or psychotherapeutic treatment during the observation period.
Time frame: Months 6 and 9.
Plan to share: Yes — Individual quantitative participant data that underlie the reported results, after deidentification (text, tables and figures).
Supporting information: Study protocol
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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