Efficacy of an Online Program for the Treatment of Mild and Moderate Depression

NCT ID: NCT02312583

Last Updated: 2016-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Psychoeducational online information

Psychoeducational online information. During 7 weeks as a complement to the usual treatment.

Group Type SHAM_COMPARATOR

Psychoeducational online information

Intervention Type BEHAVIORAL

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.

iFightDepression online programme. During 7 weeks as a complement to the usual treatment.

Group Type EXPERIMENTAL

iFightDepression online programme

Intervention Type BEHAVIORAL

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

Interventions

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Psychoeducational online information

Psychoeducational online information. During 7 weeks as a complement to the usual treatment. Participants will have access to online psychoeducational material for depression.

Intervention Type BEHAVIORAL

iFightDepression online programme

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Víctor Pérez

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victor Perez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Neuropsychiatry and Addictions (INAD). Parc de Salut Mar, Hospital del Mar

Locations

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Institute of Neuropsychiatry and Addictions (INAD). Parc de Salut Mar, Hospital del Mar. Passeig Maritin, 25-29.

Barcelona, Barcelona, Spain

Site Status RECRUITING

Hospital de Sant Pau de Barcelona. Department of Psychiatry. Servicio de Psiquiatria. Carrer de Sant Quintí, 89

Barcelona, , Spain

Site Status RECRUITING

Red de Salud Mental de Guipúzkoa (Guipuzcoan Mental Health Network). Pº Dr.Begiristain, 115 (Aránzazu building).

Donostia / San Sebastian, , Spain

Site Status RECRUITING

Hospital Universitario de la Princesa. Department of Psychiatry. Calle de Diego León, 62

Madrid, , Spain

Site Status RECRUITING

Hospital Parc Taulí de Sabadell. Community Mental Health Services. Parc Taulí 1,

Sabadell, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Victor Perez, MD, PhD

Role: CONTACT

+34932483495

Azucena Justicia, RMN, MSc

Role: CONTACT

+34932483495

Facility Contacts

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Victor Perez, MD, PhD

Role: primary

+34932483495

Dolors Puigdemont, MD

Role: primary

+34935537837

Andrea Gabilondo, MD, PhD

Role: primary

+34943006066

Jesus Gorosabel, MD, PhD

Role: primary

+34915 644 255

Eva Aguilar, MD

Role: primary

+34937458376

References

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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.

Reference Type DERIVED
PMID: 28420367 (View on PubMed)

Other Identifiers

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iFightDepression

Identifier Type: -

Identifier Source: org_study_id

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