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

Effectiveness of an Internet-based Intervention for the Treatment of Depression: Towards the Improvement of the Management of Depression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03093467
Acronym
ASCENSO
Enrollment
167
Registered
2017-03-28
Start date
2017-05-29
Completion date
2019-11-13
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Internet, Mental Health

Brief 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.

Detailed description

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.

Interventions

BEHAVIORALASCENSO

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

DRUGAntidepressants 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.

BEHAVIORALPsychotherapy

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

Sponsors

Psicomedica Clinical & Research Group, Chile
CollaboratorUNKNOWN
University Hospital Heidelberg
CollaboratorOTHER
National Fund for Research and Development in Health, Chile
CollaboratorOTHER
Instituto Milenio para Investigación en Depresión y Personalidad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Open randomized controlled trial in one mental health center.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of major depression disorder * Internet access

Exclusion criteria

* previous suicide attempt * hospitalization for a previous depressive episode * a history of psychotic symptoms * bipolar disorder * organic brain disorders * any serious disorders related to substance abuse or dependence * antisocial personality disorder * a serious medical condition or severe cognitive impairment * lack of knowledge of the Spanish language * illiteracy * refusal or revocation of patient consent. Patients will be evaluated using the MINI International Neuropsychiatric interview, Spanish for Chile Translation Version 6.0.0.

Design outcomes

Primary

MeasureTime frameDescription
Change in depressivity assessed with the Beck's Depression Inventory I (BDI-I)Baseline, months 6 and 9.Beck's Depression Inventory I (BDI-I) total score (score range 0 - 63)

Secondary

MeasureTime frameDescription
Change in quality of life change assessed with the EuroQol/EQ-5DBaseline, months 6 and 9.EuroQol/EQ-5D (EQ-index range 0 - 1)

Other

MeasureTime frameDescription
Number of attended and missed treatment appointmentsMonths 6 and 9.Adherence to treatment in terms of patients' attendance to medical controls and psychotherapy sessions.
Number of patients that dropout from treatmentMonths 6 and 9.Number of patients that dropout from psychiatric or psychotherapeutic treatment during the observation period.

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026