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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Parc de Salut Mar
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Víctor Pérez, Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT02312583
First received: December 4, 2014
Last updated: October 3, 2016
Last verified: October 2016
  Purpose
iFighDepression is an online self-help programme based on cognitive-behavioral therapy that could be useful for the treatment of mild to moderate depression

Condition Intervention
Depression
Behavioral: Psychoeducational online information
Behavioral: iFightDepression online programme

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy the Online Program iFightDepression for the Treatment of Mild and Moderate Depression

Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 310
Study Start Date: January 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02312583

Contacts
Contact: Victor Perez, MD, PhD +34932483495 VPerezSola@parcdesalutmar.cat
Contact: Azucena Justicia, RMN, MSc +34932483495 ajusticia@imim.es

Locations
Spain
Institute of Neuropsychiatry and Addictions (INAD). Parc de Salut Mar, Hospital del Mar. Passeig Maritin, 25-29. Recruiting
Barcelona, Spain, 08003
Contact: Victor Perez, MD, PhD    +34932483495    VPerezSola@parcdesalutmar.ca   
Principal Investigator: Victor Sola, MD, PhD         
Sub-Investigator: Azucena Justicia, RMN, MSc         
Hospital de Sant Pau de Barcelona. Department of Psychiatry. Servicio de Psiquiatria. Carrer de Sant Quintí, 89 Recruiting
Barcelona, Spain, 08026
Contact: Dolors Puigdemont, MD    +34935537837      
Principal Investigator: Dolors Puigdemont, MD         
Red de Salud Mental de Guipúzkoa (Guipuzcoan Mental Health Network). Pº Dr.Begiristain, 115 (Aránzazu building). Recruiting
Donostia-San Sebastián, Spain, 20014
Contact: Andrea Gabilondo, MD, PhD    +34943006066      
Principal Investigator: Andrea Gabilondo, MD, PhD         
Sub-Investigator: Alvaro Iruin, MD, PhD         
Hospital Universitario de la Princesa. Department of Psychiatry. Calle de Diego León, 62 Recruiting
Madrid, Spain, 28006
Contact: Jesus Gorosabel, MD, PhD    +34915 644 255      
Principal Investigator: Jesus Gorosabel, MD, PhD         
Hospital Parc Taulí de Sabadell. Community Mental Health Services. Parc Taulí 1, Recruiting
Sabadell, Spain, 08028
Contact: Eva Aguilar, MD    +34937458376      
Principal Investigator: Eva Aguilar, MD         
Sub-Investigator: Annabel Cebria, CP, PhD         
Sponsors and Collaborators
Parc de Salut Mar
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
  More Information

Responsible Party: Víctor Pérez, MD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02312583     History of Changes
Other Study ID Numbers: iFightDepression
Study First Received: December 4, 2014
Last Updated: October 3, 2016

Keywords provided by Parc de Salut Mar:
depression
cognitive-behavior intervention

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Complement System Proteins
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 26, 2017