Effectiveness of an Internet-based Intervention for the Treatment of Depression (ASCENSO)

April 5, 2021 updated by: Álvaro Carrasco, Instituto Milenio para Investigación en Depresión y Personalidad

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • RM
      • Santiago, RM, Chile
        • Psicomedica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
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
Internet-based program: an adjunct support and monitoring system for the treatment of depression.
Other Names:
  • Internet-based program
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.
Other Names:
  • Psychiatric treatment
Behavioral: Psychotherapy
Usual treatment: brief psychotherapy. One session per week, a total of 9 sessions in average.
Active Comparator: Control
Patients receive psychiatric treatment and psychotherapy as usual.
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.
Other Names:
  • Psychiatric treatment
Behavioral: Psychotherapy
Usual treatment: brief psychotherapy. One session per week, a total of 9 sessions in average.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, months 6 and 9.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, months 6 and 9.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Months 6 and 9.
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.
Months 6 and 9.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Milenio para Investigación en Depresión y Personalidad

Collaborators

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

Investigators

  • Principal Investigator: Álvaro E. Carrasco, PhD, Millennium institute for research on depression and personality (MIDAP)
  • Principal Investigator: Janet C. Pérez, PhD, Millennium institute for research on depression and personality (MIDAP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2017

Primary Completion (Actual)

November 13, 2019

Study Completion (Actual)

November 13, 2019

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (Actual)

March 28, 2017

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SA16I0173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual quantitative participant data that underlie the reported results, after deidentification (text, tables and figures).

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication

IPD Sharing Access Criteria

These data will be available to researchers who provide a methodologically sound proposal for the purposes of achieving specific aims outlined in that proposal. Proposals should be directed to J. Carola Pérez via email (janetperez@udd.cl) or Olga Fernandez (mofernandez36@gmail.com) and will be reviewed by both researchers. Requests to access data to undertake hypothesis-driven research will not be unreasonably withheld. To gain access, data requesters will need to sign a data access agreement and to confirm that data will only be used for the agreed purpose for which access was granted and this these data will be not shared to other people.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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