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

October 3, 2016 updated by: Víctor Pérez, Parc de Salut Mar

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

iFighDepression is an online self-help programme based on cognitive-behavioral therapy that could be useful for the treatment of mild to moderate depression

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

310

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Institute of Neuropsychiatry and Addictions (INAD). Parc de Salut Mar, Hospital del Mar. Passeig Maritin, 25-29.
        • Contact:
        • Principal Investigator:
          • Victor Sola, MD, PhD
        • Sub-Investigator:
          • Azucena Justicia, RMN, MSc
      • Barcelona, Spain, 08026
        • Recruiting
        • Hospital de Sant Pau de Barcelona. Department of Psychiatry. Servicio de Psiquiatria. Carrer de Sant Quintí, 89
        • Contact:
          • Dolors Puigdemont, MD
          • Phone Number: +34935537837
        • Principal Investigator:
          • Dolors Puigdemont, MD
      • Donostia-San Sebastián, Spain, 20014
        • Recruiting
        • Red de Salud Mental de Guipúzkoa (Guipuzcoan Mental Health Network). Pº Dr.Begiristain, 115 (Aránzazu building).
        • Contact:
          • Andrea Gabilondo, MD, PhD
          • Phone Number: +34943006066
        • Principal Investigator:
          • Andrea Gabilondo, MD, PhD
        • Sub-Investigator:
          • Alvaro Iruin, MD, PhD
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de la Princesa. Department of Psychiatry. Calle de Diego León, 62
        • Contact:
          • Jesus Gorosabel, MD, PhD
          • Phone Number: +34915 644 255
        • Principal Investigator:
          • Jesus Gorosabel, MD, PhD
      • Sabadell, Spain, 08028
        • Recruiting
        • Hospital Parc Taulí de Sabadell. Community Mental Health Services. Parc Taulí 1,
        • Contact:
          • Eva Aguilar, MD
          • Phone Number: +34937458376
        • Principal Investigator:
          • Eva Aguilar, MD
        • Sub-Investigator:
          • Annabel Cebria, CP, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Psychoeducational online information
Psychoeducational online information. During 7 weeks as a complement to the usual treatment.
Behavioral: 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.
Experimental: iFightDepression online programme.
iFightDepression online programme. During 7 weeks as a complement to the usual treatment.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to 7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Clinical Global Impression of Severity and Improvement
Time Frame: From baseline to 7 weeks

Clinical Severity will be assessed using the Scale of Clinical Global Impression of Severity and Improvement (ICG-s and ICG-m). Hetero and Self-Administered versions.

Scale of Clinical Global Impression of Severity and Improvement (ICG-s) at baseline. and at 7 weeks Scale of Clinical Global Impression of Severity and Improvement (ICG-m) at baseline and at 7 weeks.
From baseline to 7 weeks
Change in depressive symptomatology
Time Frame: From baseline to 7 weeks
Depressive symptomatology measured by the Self-Report Patient Health Questionnaire-9 (PHQ-9). Measure will be done once a week.
From baseline to 7 weeks
Change in the Remission from Depression
Time Frame: From baseline to 7 weeks
Remission from Depression Questionnaire (RDQ): Self-Report in relation to different domains considered as relevant by the patients themselves in defining the construct of remission in the scope of depressive disorders. Measure will be done once a week.
From baseline to 7 weeks
Change in quality of life
Time Frame: From baseline to 7 weeks
Change measured using the EuroQoL Quality of Life Scale (EQ-5 d). It is a Self-Report measure of health variables which is commonly used as an indicator of quality of life.
From baseline to 7 weeks
Change in functional impairment
Time Frame: From baseline to 7 weeks
Functional impairment assessed by using the Functioning Assessment Short Test (FAST). It evaluates the functional impairment in patients suffering from mental illness, including the Major Depression.
From baseline to 7 weeks
Users satisfaction score
Time Frame: One measure at 7 weeks
User´s satisfaction by using the Satisfaction Questionnaire: a questionnaire of satisfaction used in the validation of the programme iFightDepression within the project PREDI-NU. It includes questions about the manageability of the programme and the beneficial aspects perceived by the user.
One measure at 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Victor Perez, MD, PhD, Institute of Neuropsychiatry and Addictions (INAD). Parc de Salut Mar, Hospital del Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 9, 2014

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iFightDepression

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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