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

NCT03093467 | Completed

• 1 other identifier: SA16I0173
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Internet; Mental Health

Outcome Measures

Primary Outcomes (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)

  Baseline, months 6 and 9.

Secondary Outcomes (1)

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

  Baseline, months 6 and 9.

Other Outcomes (2)

• Number of attended and missed treatment appointments

  Months 6 and 9.

• Number of patients that dropout from treatment

  Months 6 and 9.

Study Arms (2)

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; Drug: Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers.; Behavioral: Psychotherapy

Control

ACTIVE COMPARATOR

Patients receive psychiatric treatment and psychotherapy as usual.

Drug: Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers.; Behavioral: Psychotherapy

Interventions

ASCENSO BEHAVIORAL

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

Also known as: Internet-based program

Experimental

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

Also known as: Psychiatric treatment

Control; Experimental

Psychotherapy BEHAVIORAL

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

Control; Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of major depression disorder
• Internet access

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Milenio para Investigación en Depresión y Personalidad: lead
• Psicomedica Clinical & Research Group, Chile: collaborator
• University Hospital Heidelberg: collaborator
• National Fund for Research and Development in Health, Chile: collaborator

Study Sites (1)

Psicomedica

Santiago, RM, Chile

Location

Related Publications (8)

• 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.

  PMID: 22051709 BACKGROUND

• 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.

  PMID: 20183695 BACKGROUND

• 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.

  PMID: 26741190 BACKGROUND

• 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.

  PMID: 17657327 BACKGROUND

• 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.

  PMID: 25803266 BACKGROUND

• 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.

  PMID: 26808817 BACKGROUND

• 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.

  PMID: 15550801 BACKGROUND

• 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.

  PMID: 34927594 DERIVED

Related Links

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

MeSH Terms

Conditions

Depression; Psychological Well-Being

Interventions

Antidepressive Agents; Anti-Anxiety Agents; Antipsychotic Agents; Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Behavioral Disciplines and Activities

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: Open randomized controlled trial in one mental health center.

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 28, 2017
• Study Start: May 29, 2017
• Primary Completion: November 13, 2019
• Study Completion: November 13, 2019
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication
• 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.

Locations

CL (1)