Efficacy of an Online Program for the Treatment of Mild and Moderate Depression
Efficacy the Online Program iFightDepression for the Treatment of Mild and Moderate Depression
1 other identifier
interventional
310
1 country
5
Brief Summary
iFighDepression is an online self-help programme based on cognitive-behavioral therapy that could be useful for the treatment of mild to moderate depression
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Jan 2015
Longer than P75 for not_applicable depression
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2014
CompletedFirst Posted
Study publicly available on registry
December 9, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 4, 2016
October 1, 2016
2.9 years
December 4, 2014
October 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in depression Scale
Efficacy will be assessed by using the Hamilton Depression Scale, version 17 items (HDRS-17). The HDRS-17 will be administered at baseline, 4 weeks and 7 weeks.
From baseline to 7 weeks
Secondary Outcomes (6)
Change in the Clinical Global Impression of Severity and Improvement
From baseline to 7 weeks
Change in depressive symptomatology
From baseline to 7 weeks
Change in the Remission from Depression
From baseline to 7 weeks
Change in quality of life
From baseline to 7 weeks
Change in functional impairment
From baseline to 7 weeks
- +1 more secondary outcomes
Study Arms (2)
Psychoeducational online information
SHAM COMPARATORPsychoeducational online information. During 7 weeks as a complement to the usual treatment.
iFightDepression online programme.
EXPERIMENTALiFightDepression online programme. During 7 weeks as a complement to the usual treatment.
Interventions
Psychoeducational online information. During 7 weeks as a complement to the usual treatment. Participants will have access to online psychoeducational material for depression.
iFightDepression online programme. During 7 weeks as a complement to the usual treatment. Participants will complete the modules of a structured online programme for depression
Eligibility Criteria
You may qualify if:
- Diagnosis of major depressive disorder according to Diagnostic and Statistical Manual (DSM-IV-TR) criteria.
- Clinical severity between mild and moderate (according to ICG severity scale).
- A minimum of reading comprehension and knowledge of internet browsing.
- Availability to access internet during the 7 weeks of the intervention.
- Informed written consent provided.
You may not qualify if:
- Suicidal ideation (assessed by the HDRS and clinical interview).
- Presence of delusional ideas or hallucinations, consistent or not with the mood.
- Other concomitant psychiatric pathologies of the Axis I or Axis II according to Diagnostic and Statistical Manual (DSM-IV-TR) at the time of entry to the study.
- To be currently enrolled in a structured programme/treatment of psychotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Parc de Salut Marlead
- Instituto de Salud Carlos IIIcollaborator
Study Sites (5)
Institute of Neuropsychiatry and Addictions (INAD). Parc de Salut Mar, Hospital del Mar. Passeig Maritin, 25-29.
Barcelona, Barcelona, 08003, Spain
Hospital de Sant Pau de Barcelona. Department of Psychiatry. Servicio de Psiquiatria. Carrer de Sant Quintí, 89
Barcelona, 08026, Spain
Red de Salud Mental de Guipúzkoa (Guipuzcoan Mental Health Network). Pº Dr.Begiristain, 115 (Aránzazu building).
Donostia / San Sebastian, 20014, Spain
Hospital Universitario de la Princesa. Department of Psychiatry. Calle de Diego León, 62
Madrid, 28006, Spain
Hospital Parc Taulí de Sabadell. Community Mental Health Services. Parc Taulí 1,
Sabadell, 08028, Spain
Related Publications (1)
Justicia A, Elices M, Cebria AI, Palao DJ, Gorosabel J, Puigdemont D, de Diego-Adelino J, Gabilondo A, Iruin A, Hegerl U, Perez V. Rationale and methods of the iFightDepression study: A double-blind, randomized controlled trial evaluating the efficacy of an internet-based self-management tool for moderate to mild depression. BMC Psychiatry. 2017 Apr 19;17(1):143. doi: 10.1186/s12888-017-1306-2.
PMID: 28420367DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victor Perez, MD, PhD
Institute of Neuropsychiatry and Addictions (INAD). Parc de Salut Mar, Hospital del Mar
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
December 4, 2014
First Posted
December 9, 2014
Study Start
January 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
October 4, 2016
Record last verified: 2016-10