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

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ClinicalTrials.gov Identifier: NCT02312583
Recruitment Status : Unknown
Verified October 2016 by Víctor Pérez, Parc de Salut Mar.
Recruitment status was:  Recruiting
First Posted : December 9, 2014
Last Update Posted : October 4, 2016
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Víctor Pérez, Parc de Salut Mar

Tracking Information
First Submitted Date  ICMJE December 4, 2014
First Posted Date  ICMJE December 9, 2014
Last Update Posted Date October 4, 2016
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02312583 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of an Online Program for the Treatment of Mild and Moderate Depression
Official Title  ICMJE Efficacy the Online Program iFightDepression for the Treatment of Mild and Moderate Depression
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • 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.
  • 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

Study Arms  ICMJE
  • Sham Comparator: Psychoeducational online information
    Psychoeducational online information. During 7 weeks as a complement to the usual treatment.
    Intervention: Behavioral: Psychoeducational online information
  • Experimental: iFightDepression online programme.
    iFightDepression online programme. During 7 weeks as a complement to the usual treatment.
    Intervention: Behavioral: iFightDepression online programme
Publications * Justicia A, Elices M, Cebria AI, Palao DJ, Gorosabel J, Puigdemont D, de Diego-Adeliño J, Gabilondo A, Iruin A, Hegerl U, Pérez 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 4, 2014)
310
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02312583
Other Study ID Numbers  ICMJE iFightDepression
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Víctor Pérez, Parc de Salut Mar
Study Sponsor  ICMJE Parc de Salut Mar
Collaborators  ICMJE Instituto de Salud Carlos III
Investigators  ICMJE
Principal Investigator: Victor Perez, MD, PhD Institute of Neuropsychiatry and Addictions (INAD). Parc de Salut Mar, Hospital del Mar
PRS Account Parc de Salut Mar
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP