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

NCT ID: NCT03093467

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-29
• Study Completion Date: 2019-11-13

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

ASCENSO

Intervention Type: BEHAVIORAL

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

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

Intervention Type: 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.

Psychotherapy

Intervention Type: BEHAVIORAL

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

Control

Patients receive psychiatric treatment and psychotherapy as usual.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Psychotherapy

Intervention Type: BEHAVIORAL

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

Interventions

ASCENSO

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

Psychotherapy

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Internet-based program; Psychiatric treatment

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Psicomedica Clinical & Research Group, Chile

UNKNOWN

Sponsor Role: collaborator

University Hospital Heidelberg

OTHER

Sponsor Role: collaborator

National Fund for Research and Development in Health, Chile

OTHER

Sponsor Role: collaborator

Instituto Milenio para Investigación en Depresión y Personalidad

OTHER

Sponsor Role: lead

Responsible Party

Álvaro Carrasco

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Álvaro E. Carrasco, PhD

Role: PRINCIPAL_INVESTIGATOR

Millennium institute for research on depression and personality (MIDAP)

Janet C. Pérez, PhD

Role: PRINCIPAL_INVESTIGATOR

Millennium institute for research on depression and personality (MIDAP)

Locations

Psicomedica

Santiago, RM, Chile

Countries

Chile

References

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.

Reference Type: BACKGROUND

PMID: 22051709 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20183695 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26741190 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17657327 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25803266 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26808817 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15550801 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34927594 (View on PubMed)

Related Links

http://ww3.psicomedica.cl/

Mental health clinic. Recruitment center.

http://midap.org

Millennium Institute for research on depression and personality

http://psyres.de/

Center for psychotherapy research, Heidelberg University Hospital

http://www.conicyt.cl/fonis/

Fund for research and development in health

Other Identifiers

SA16I0173

Identifier Type: -

Identifier Source: org_study_id