DepressionNCT02312583
Efficacy of an Online Program for the Treatment of Mild and Moderate Depression
A study testing Psychoeducational online information and iFightDepression online programme in people with Depression, run by Parc de Salut Mar at 5 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Psychoeducational online information and iFightDepression online programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 5 sitesSpain
- Study dates
- Jan 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites, 5 recruiting
- Recruiting
Institute of Neuropsychiatry and Addictions (INAD). Parc de Salut Mar, Hospital del Mar. Passeig Maritin, 25-29.
Barcelona, Barcelona, 08003
Victor Perez, MD, PhD, +34932483495, VPerezSola@parcdesalutmar.ca
Victor Sola, MD, PhD
- Recruiting
Hospital de Sant Pau de Barcelona. Department of Psychiatry. Servicio de Psiquiatria. Carrer de Sant Quintí, 89
Barcelona, 08026
Dolors Puigdemont, MD, +34935537837
Dolors Puigdemont, MD
- Recruiting
Red de Salud Mental de Guipúzkoa (Guipuzcoan Mental Health Network). Pº Dr.Begiristain, 115 (Aránzazu building).
Donostia / San Sebastian, 20014
Andrea Gabilondo, MD, PhD, +34943006066
Andrea Gabilondo, MD, PhD
- Recruiting
Hospital Universitario de la Princesa. Department of Psychiatry. Calle de Diego León, 62
Madrid, 28006
Jesus Gorosabel, MD, PhD, +34915 644 255
Jesus Gorosabel, MD, PhD
- Recruiting
Hospital Parc Taulí de Sabadell. Community Mental Health Services. Parc Taulí 1,
Sabadell, 08028
Eva Aguilar, MD, +34937458376
Eva Aguilar, MD
About this study
Official title: 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
Read the 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
- Conditions
- Depression
- Being tested
- Psychoeducational online information, iFightDepression online programme
- Keywords
- depression, cognitive-behavior intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational online informationBehavioural
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 programmeBehavioural
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 group | Role | What they receive |
|---|---|---|
| Psychoeducational online information | Sham comparator | Psychoeducational online information. During 7 weeks as a complement to the usual treatment. Receives: Behavioral: Psychoeducational online information |
| iFightDepression online programme. | Experimental | iFightDepression online programme. During 7 weeks as a complement to the usual treatment. Receives: Behavioral: iFightDepression online programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 7 weeks
Secondary outcomes (6)
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.
Measured: From baseline to 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.
Measured: From baseline to 7 weeks
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.
Measured: From baseline to 7 weeks
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.
Measured: From baseline to 7 weeks
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.
Measured: From baseline to 7 weeks
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.
Measured: One measure at 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Víctor Pérez, Parc de Salut Mar
- Investigators
- Victor Perez, MD, PhD, Principal investigator, Institute of Neuropsychiatry and Addictions (INAD). Parc de Salut Mar, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312583
- Sponsor's protocol ID
- iFightDepression
- Status last verified
- Oct 2016
- First submitted
- 4 Dec 2014
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28420367
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy the Online Program iFightDepression for the Treatment of Mild and Moderate Depression
- ClinicalTrials.gov ID
- NCT02312583
- Acronym / sponsor ID
- iFightDepression
- Conditions
- Depression
- Keywords
- depression, cognitive-behavior intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational online information | Sham comparator | Behavioral: Psychoeducational online informationPsychoeducational online information. During 7 weeks as a complement to the usual treatment. |
| iFightDepression online programme. | Experimental | Behavioral: iFightDepression online programmeiFightDepression online programme. During 7 weeks as a complement to the usual treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational online informationPsychoeducational online information. During 7 weeks as a complement to the usual treatment. Participants will have access to online psychoeducational material for depression. | Behavioural | Psychoeducational online information |
| iFightDepression online programmeiFightDepression online programme. During 7 weeks as a complement to the usual treatment. Participants will complete the modules of a structured online programme for depression | Behavioural | iFightDepression online programme. |
Primary outcome
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.
6 secondary outcomes
Change in the Clinical Global Impression of Severity and Improvement
Time frame: From baseline to 7 weeks
Change in depressive symptomatology
Time frame: From baseline to 7 weeks
Change in the Remission from Depression
Time frame: From baseline to 7 weeks
Change in quality of life
Time frame: From baseline to 7 weeks
Change in functional impairment
Time frame: From baseline to 7 weeks
Users satisfaction score
Time frame: One measure at 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Derived from this study: PubMed 28420367Justicia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Perez, MD, PhD principal investigator
Institute of Neuropsychiatry and Addictions (INAD). Parc de Salut Mar, Hospital del Mar
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational online information and iFightDepression online programme in people with Depression, run by Parc de Salut Mar at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victor Perez, MD, PhD (+34932483495, VPerezSola@parcdesalutmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression Scale (time frame: From baseline to 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02312583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.