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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02312583
• Other study ID #: iFightDepression
• Status: Recruiting
• Phase: N/A
• First received: December 4, 2014
• Last updated: October 3, 2016
• Start date: January 2015
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: Parc de Salut Mar
• Contact: Victor Perez, MD, PhD
• Phone: +34932483495
• Email: VPerezSola[@]parcdesalutmar.cat
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.
• 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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Parc de Salut Mar	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to 7 weeks	No
Secondary	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.	From baseline to 7 weeks	No
Secondary	Change in depressive symptomatology	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	No
Secondary	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.	From baseline to 7 weeks	No
Secondary	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.	From baseline to 7 weeks	No
Secondary	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.	From baseline to 7 weeks	No
Secondary	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.	One measure at 7 weeks	No