Clinical trial NCT03093467: Effectiveness of an Internet-based Intervention for the Treatment of Depression
Official title: Effectiveness of an Internet-based Intervention for the Treatment of Depression: Towards the Improvement of the Management of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Internet
Mental Health
Lead sponsor: Instituto Milenio para Investigación en Depresión y Personalidad
Sponsor class: OTHER
Collaborators: name: Psicomedica Clinical & Research Group, Chile
name: University Hospital Heidelberg
name: National Fund for Research and Development in Health, Chile
First posted: 2017-03-28
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open randomized controlled trial in one mental health center.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in depressivity assessed with the Beck's Depression Inventory I (BDI-I)
timeFrame: Baseline, months 6 and 9.
Secondary outcomes:
measure: Change in quality of life change assessed with the EuroQol/EQ-5D
timeFrame: Baseline, months 6 and 9.
Other outcomes:
measure: Number of attended and missed treatment appointments
timeFrame: Months 6 and 9.
measure: Number of patients that dropout from treatment
timeFrame: Months 6 and 9.
Locations:
city: Santiago
country: Chile
facility: Psicomedica
state: RM
Study officials:
affiliation: Millennium institute for research on depression and personality (MIDAP)
name: Álvaro E. Carrasco, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Millennium institute for research on depression and personality (MIDAP)
name: Janet C. Pérez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Perez JC, Fernandez O, Caceres C, Carrasco AE, Moessner M, Bauer S, Espinosa-Duque D, Gloger S, Krause M. An Adjunctive Internet-Based Intervention to Enhance Treatment for Depression in Adults: Randomized Controlled Trial. JMIR Ment Health. 2021 Dec 16;8(12):e26814. doi: 10.2196/26814.