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

Depression Clinical Trial

— ASCENSO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093467
• Other study ID #: SA16I0173
• Status: Completed
• Phase: N/A
• Start date: May 29, 2017
• Est. completion date: November 13, 2019

Study information

• Verified date: April 2021
• Source: Instituto Milenio para Investigación en Depresión y Personalidad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: November 13, 2019
• Est. primary completion date: November 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

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.

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

Locations

Country	Name	City	State
Chile	Psicomedica	Santiago	RM

Sponsors (4)

Lead Sponsor	Collaborator
Instituto Milenio para Investigación en Depresión y Personalidad	National Fund for Research and Development in Health, Chile, Psicomedica Clinical & Research Group, Chile, University Hospital Heidelberg

Country where clinical trial is conducted

Chile, 

References & Publications (7)

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. doi: /S0034-98872011000500005. Epub 2011 Sep 16. Spanish. — View Citation

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. — View Citation

Espinosa HD, Carrasco Á, Moessner M, Cáceres 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. — View Citation

Fritsch R, Araya R, Solís 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. — View Citation

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. Review. — View Citation

Kordy H, Wolf M, Aulich K, Bürgy M, Hegerl U, Hüsing 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of attended and missed treatment appointments	Adherence to treatment in terms of patients' attendance to medical controls and psychotherapy sessions.	Months 6 and 9.
Other	Number of patients that dropout from treatment	Number of patients that dropout from psychiatric or psychotherapeutic treatment during the observation period.	Months 6 and 9.
Primary	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)	Baseline, months 6 and 9.
Secondary	Change in quality of life change assessed with the EuroQol/EQ-5D	EuroQol/EQ-5D (EQ-index range 0 - 1)	Baseline, months 6 and 9.

External Links

•   Center for psychotherapy research, Heidelberg University Hospital
•   Fund for research and development in health
•   Mental health clinic. Recruitment center.
•   Millennium Institute for research on depression and personality