Clinical trial NCT02312583: Efficacy of an Online Program for the Treatment of Mild and Moderate Depression
Official title: Efficacy the Online Program iFightDepression for the Treatment of Mild and Moderate Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: depression
cognitive-behavior intervention
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2014-12-09
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Major depression (MD) is a disease with a great impact on people´s functioning and is the second leading cause of disability worldwide. It is a condition with a high prevalence, about 10% of men and 20% of women in the population will be diagnosed MD throughout their lives, and has an effect on high economic costs to health services.

While there are many effective therapeutic options for the treatment of depression, many people with depressive episodes do not receive an appropriate treatment or, in fact, do not receive any treatment at all. The social stigma, difficulties to access mental health services, to integrate therapy sessions into working life, or problems to pay for treatment are some of the main barriers to receive adequate treatment.

On-line interventions are easily accessible and low cost, and different studies suggest that these interventions have significant and lasting improvements in different mental disorders. These studies indicate that this type of treatment would be indicated for disorders that, as the case of MD, have a high prevalence and relatively low help-seeking for treatment.

iFighDepression is an online self-help programme for mild to moderate depression that has been developed in the context of the European project Preventing Depression and Improving Awareness through Networking in the European Union (PREDI-NU) which is managed by the European Alliance Against Depression (EAAD). It involves the most complete integration of the cognitive-behavioral online programs available to date, which is a format of intervention that has been proven effective in reducing depressive symptoms in several randomized controlled trials. IFightDepression is currently in pilot phase in 7 European Union countries, including Spain.

The purpose of this project is to study the therapeutic effect of the iFightDepression online programme in patients with mild to moderate depression

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in depression Scale
timeFrame: From baseline to 7 weeks
Secondary outcomes:
measure: Change in the Clinical Global Impression of Severity and Improvement
timeFrame: From baseline to 7 weeks
measure: Change in depressive symptomatology
timeFrame: From baseline to 7 weeks
measure: Change in the Remission from Depression
timeFrame: From baseline to 7 weeks
measure: Change in quality of life
timeFrame: From baseline to 7 weeks
measure: Change in functional impairment
timeFrame: From baseline to 7 weeks
measure: Users satisfaction score
timeFrame: One measure at 7 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institute of Neuropsychiatry and Addictions (INAD). Parc de Salut Mar, Hospital del Mar. Passeig Maritin, 25-29.
city: Barcelona
country: Spain
facility: Hospital de Sant Pau de Barcelona. Department of Psychiatry. Servicio de Psiquiatria. Carrer de Sant Quintí, 89
city: Donostia-San Sebastián
country: Spain
facility: Red de Salud Mental de Guipúzkoa (Guipuzcoan Mental Health Network). Pº Dr.Begiristain, 115 (Aránzazu building).
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa. Department of Psychiatry. Calle de Diego León, 62
city: Sabadell
country: Spain
facility: Hospital Parc Taulí de Sabadell. Community Mental Health Services. Parc Taulí 1,
Study officials:
affiliation: Institute of Neuropsychiatry and Addictions (INAD). Parc de Salut Mar, Hospital del Mar
name: Victor Perez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.