ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03093467
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : June 15, 2018
Sponsor:
Collaborators:
Psicomedica Clinical & Research Group, Chile
University Hospital Heidelberg
Fondo Nacional de Investigación y Desarrollo en Salud, Chile
Information provided by (Responsible Party):
Álvaro Carrasco, Instituto Milenio para Investigación en Depresión y Personalidad

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: ASCENSO Drug: Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers. Behavioral: Psychotherapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open randomized controlled trial in one mental health center.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of an Internet-based Intervention for the Treatment of Depression: Towards the Improvement of the Management of Depression
Actual Study Start Date : May 29, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Psychiatric treatment

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093467


Contacts
Contact: Álvaro E. Carrasco, PhD 56223544843 athos@med.uchile.cl
Contact: Janet C. Pérez, PhD 56223544843 janetperez@udd.cl

Locations
Chile
Psicomedica Recruiting
Santiago, RM, Chile
Contact: Cristian Caceres    562675 8700    cristian.caceres@psicomedica.cl   
Sponsors and Collaborators
Instituto Milenio para Investigación en Depresión y Personalidad
Psicomedica Clinical & Research Group, Chile
University Hospital Heidelberg
Fondo Nacional de Investigación y Desarrollo en Salud, Chile
Investigators
Principal Investigator: Álvaro E. Carrasco, PhD Millennium institute for research on depression and personality (MIDAP)

Additional Information:
Publications:

Responsible Party: Álvaro Carrasco, Researcher, Instituto Milenio para Investigación en Depresión y Personalidad
ClinicalTrials.gov Identifier: NCT03093467     History of Changes
Other Study ID Numbers: SA16I0173
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Álvaro Carrasco, Instituto Milenio para Investigación en Depresión y Personalidad:
Internet
Mental Health

Additional relevant MeSH terms:
Depressive Disorder
Mood Disorders
Mental Disorders
Depression
Behavioral Symptoms
Antidepressive Agents
Anti-Anxiety Agents
Antipsychotic Agents
Psychotropic Drugs
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs