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DepressionASCENSONCT03093467

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

A study testing ASCENSO, Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers. and Psychotherapy in people with Depression, run by Instituto Milenio para Investigación en Depresión y Personalidad at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depression
What is being tested?
ASCENSO, Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers. and Psychotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
1 siteChile
Study dates
29 May 2017to 13 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of major depression disorder
  • Internet access

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Psicomedica

    Santiago, RM

Other trials in Chile

About this study

Official title: 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.

Read the 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.

Conditions
Depression
Being tested
ASCENSO, Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers., Psychotherapy
Keywords
Internet, Mental Health
Medical subject headings
Depression, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASCENSOBehavioural

    Also called Internet-based program

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

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

    Also called Psychiatric treatment

    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.

  • PsychotherapyBehavioural

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

Study groups in NCT03093467
Study groupRoleWhat they receive
ExperimentalExperimentalParticipants 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.
Receives: Behavioral: ASCENSO; Drug: Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers.; Behavioral: Psychotherapy
ControlActive comparatorPatients receive psychiatric treatment and psychotherapy as usual.
Receives: Drug: Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers.; Behavioral: Psychotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Baseline, months 6 and 9.

Secondary outcomes (1)

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

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

    Measured: Baseline, months 6 and 9.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2017
  2. Study start29 May 2017
  3. Primary completion13 Nov 2019
  4. Study completion13 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open randomized controlled trial in one mental health center.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03093467
Sponsor's protocol ID
SA16I0173
Acronym
ASCENSO
Status last verified
Apr 2021
First submitted
14 Mar 2017
Last updated
8 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual quantitative participant data that underlie the reported results, after deidentification (text, tables and figures).

Publications

  • Alvarado R, Rojas G. [Evaluation of the program for detection and treatment of depression in Chilean primary health care centers]. Rev Med Chil. 2011 May;139(5):592-9. Epub 2011 Sep 16. Spanish.

    PubMed 22051709

  • Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196-205. doi: 10.1080/16506070903318960.

    PubMed 20183695

  • Espinosa HD, Carrasco A, Moessner M, Caceres C, Gloger S, Rojas G, Perez JC, Vanegas J, Bauer S, Krause M. Acceptability Study of "Ascenso": An Online Program for Monitoring and Supporting Patients with Depression in Chile. Telemed J E Health. 2016 Jul;22(7):577-83. doi: 10.1089/tmj.2015.0124. Epub 2016 Jan 7.

    PubMed 26741190

  • Fritsch R, Araya R, Solis J, Montt E, Pilowsky D, Rojas G. [A randomized trial of pharmacotherapy with telephone monitoring to improve treatment of depression in primary care in Santiago, Chile]. Rev Med Chil. 2007 May;135(5):587-95. Epub 2007 Jul 9. Spanish.

    PubMed 17657327

  • Hamine S, Gerth-Guyette E, Faulx D, Green BB, Ginsburg AS. Impact of mHealth chronic disease management on treatment adherence and patient outcomes: a systematic review. J Med Internet Res. 2015 Feb 24;17(2):e52. doi: 10.2196/jmir.3951.

    PubMed 25803266

  • Kordy H, Wolf M, Aulich K, Burgy M, Hegerl U, Husing J, Puschner B, Rummel-Kluge C, Vedder H, Backenstrass M. Internet-Delivered Disease Management for Recurrent Depression: A Multicenter Randomized Controlled Trial. Psychother Psychosom. 2016;85(2):91-8. doi: 10.1159/000441951. Epub 2016 Jan 26.

    PubMed 26808817

  • Neumeyer-Gromen A, Lampert T, Stark K, Kallischnigg G. Disease management programs for depression: a systematic review and meta-analysis of randomized controlled trials. Med Care. 2004 Dec;42(12):1211-21. doi: 10.1097/00005650-200412000-00008.

    PubMed 15550801

  • 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.

    PubMed 34927594

Questions about this trial

What is this clinical trial studying?

A study testing ASCENSO, Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers. and Psychotherapy in people with Depression, run by Instituto Milenio para Investigación en Depresión y Personalidad at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in depressivity assessed with the Beck's Depression Inventory I (BDI-I) (time frame: Baseline, months 6 and 9.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03093467, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.

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