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

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Psychoeducational online information
iFightDepression online programme
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, cognitive-behavior intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Neuropsychiatry and Addictions (INAD). Parc de Salut Mar, Hospital del Mar. Passeig Maritin, 25-29.Recruiting
  • Hospital de Sant Pau de Barcelona. Department of Psychiatry. Servicio de Psiquiatria. Carrer de Sant Quintí, 89Recruiting
  • Red de Salud Mental de Guipúzkoa (Guipuzcoan Mental Health Network). Pº Dr.Begiristain, 115 (Aránzazu building).Recruiting
  • Hospital Universitario de la Princesa. Department of Psychiatry. Calle de Diego León, 62Recruiting
  • Hospital Parc Taulí de Sabadell. Community Mental Health Services. Parc Taulí 1,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Psychoeducational online information

iFightDepression online programme.

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in depression Scale
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
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
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
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
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
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
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.

Full Information

First Posted
December 4, 2014
Last Updated
October 3, 2016
Sponsor
Parc de Salut Mar
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT02312583
Brief Title
Efficacy of an Online Program for the Treatment of Mild and Moderate Depression
Official Title
Efficacy the Online Program iFightDepression for the Treatment of Mild and Moderate Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
Collaborators
Instituto de Salud Carlos III

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, cognitive-behavior intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychoeducational online information
Arm Type
Sham Comparator
Arm Description
Psychoeducational online information. During 7 weeks as a complement to the usual treatment.
Arm Title
iFightDepression online programme.
Arm Type
Experimental
Arm Description
iFightDepression online programme. During 7 weeks as a complement to the usual treatment.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational online information
Intervention Description
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
Intervention Name(s)
iFightDepression online programme
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in depression Scale
Description
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.
Time Frame
From baseline to 7 weeks
Secondary Outcome Measure Information:
Title
Change in the Clinical Global Impression of Severity and Improvement
Description
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.
Time Frame
From baseline to 7 weeks
Title
Change in depressive symptomatology
Description
Depressive symptomatology measured by the Self-Report Patient Health Questionnaire-9 (PHQ-9). Measure will be done once a week.
Time Frame
From baseline to 7 weeks
Title
Change in the Remission from Depression
Description
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.
Time Frame
From baseline to 7 weeks
Title
Change in quality of life
Description
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.
Time Frame
From baseline to 7 weeks
Title
Change in functional impairment
Description
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.
Time Frame
From baseline to 7 weeks
Title
Users satisfaction score
Description
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.
Time Frame
One measure at 7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victor Perez, MD, PhD
Phone
+34932483495
Email
VPerezSola@parcdesalutmar.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Azucena Justicia, RMN, MSc
Phone
+34932483495
Email
ajusticia@imim.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Perez, MD, PhD
Organizational Affiliation
Institute of Neuropsychiatry and Addictions (INAD). Parc de Salut Mar, Hospital del Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Neuropsychiatry and Addictions (INAD). Parc de Salut Mar, Hospital del Mar. Passeig Maritin, 25-29.
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Perez, MD, PhD
Phone
+34932483495
Email
VPerezSola@parcdesalutmar.ca
First Name & Middle Initial & Last Name & Degree
Victor Sola, MD, PhD
First Name & Middle Initial & Last Name & Degree
Azucena Justicia, RMN, MSc
Facility Name
Hospital de Sant Pau de Barcelona. Department of Psychiatry. Servicio de Psiquiatria. Carrer de Sant Quintí, 89
City
Barcelona
ZIP/Postal Code
08026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dolors Puigdemont, MD
Phone
+34935537837
First Name & Middle Initial & Last Name & Degree
Dolors Puigdemont, MD
Facility Name
Red de Salud Mental de Guipúzkoa (Guipuzcoan Mental Health Network). Pº Dr.Begiristain, 115 (Aránzazu building).
City
Donostia-San Sebastián
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Gabilondo, MD, PhD
Phone
+34943006066
First Name & Middle Initial & Last Name & Degree
Andrea Gabilondo, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alvaro Iruin, MD, PhD
Facility Name
Hospital Universitario de la Princesa. Department of Psychiatry. Calle de Diego León, 62
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Gorosabel, MD, PhD
Phone
+34915 644 255
First Name & Middle Initial & Last Name & Degree
Jesus Gorosabel, MD, PhD
Facility Name
Hospital Parc Taulí de Sabadell. Community Mental Health Services. Parc Taulí 1,
City
Sabadell
ZIP/Postal Code
08028
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Aguilar, MD
Phone
+34937458376
First Name & Middle Initial & Last Name & Degree
Eva Aguilar, MD
First Name & Middle Initial & Last Name & Degree
Annabel Cebria, CP, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
28420367
Citation
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.
Results Reference
derived

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

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