Efficacy the Online Program iFightDepression for the Treatment of Mild and Moderate Depression
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 310
- Locations
- 10
- Primary Endpoint
- Change in depression Scale
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in depression Scale
Time Frame: From baseline to 7 weeks
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.
Secondary Outcomes
- Change in the Remission from Depression(From baseline to 7 weeks)
- Change in depressive symptomatology(From baseline to 7 weeks)
- Change in functional impairment(From baseline to 7 weeks)
- Change in the Clinical Global Impression of Severity and Improvement(From baseline to 7 weeks)
- Change in quality of life(From baseline to 7 weeks)
- Users satisfaction score(One measure at 7 weeks)
Investigators
Víctor Pérez
MD
Parc de Salut Mar