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Completed

NCT Number: NCT03093467

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psicomedica

Santiago, RM, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASCENSO

Behavioral

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

Other names: Internet-based program

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

Drug

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.

Other names: Psychiatric treatment

Psychotherapy

Behavioral

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

Primary outcomes

  1. Change in depressivity assessed with the Beck's Depression Inventory I (BDI-I)

    Time frame: Baseline, months 6 and 9.

    Beck's Depression Inventory I (BDI-I) total score (score range 0 - 63)

Secondary outcomes

  1. Change in quality of life change assessed with the EuroQol/EQ-5D

    Time frame: Baseline, months 6 and 9.

    EuroQol/EQ-5D (EQ-index range 0 - 1)

Other outcomes

  1. Number of attended and missed treatment appointments

    Time frame: Months 6 and 9.

    Adherence to treatment in terms of patients' attendance to medical controls and psychotherapy sessions.

  2. Number of patients that dropout from treatment

    Time frame: Months 6 and 9.

    Number of patients that dropout from psychiatric or psychotherapeutic treatment during the observation period.

Sponsors and collaborators

Lead sponsor

Instituto Milenio para Investigación en Depresión y Personalidad

Other

Collaborators

  • National Fund for Research and Development in Health, Chile
  • Psicomedica Clinical & Research Group, Chile
  • University Hospital Heidelberg

Registry information

Official study title

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

Acronym: ASCENSO

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 28, 2017
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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