Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression
NCT ID: NCT01611818
Last Updated: 2017-08-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
300 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-09-30
Study Completion Date
2016-12-31
Brief Summary
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BACKGROUND: Major depression will become the second most important cause of disability in 2020. Computerised cognitive-behaviour therapy could be an efficacious and cost-effective option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided psychotherapy have been carried out.
AIM: To assess the efficacy of low intensity vs self-guided psychotherapy for major depression in the Spanish health system.
METHODS: The study is made up of 3 phases: 1.- Development of a computerised cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter controlled, randomized study: A sample (N=450 patients) with mild/moderate depression recruited in primary care. They should have internet availability at home, not receive any previous psychological treatment, and not suffer from any other severe somatic or psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume of health and social services). Patients will be assessed at baseline, 3 and 12 months. An intention to treat and a per protocol analysis will be performed.
AIM: To assess the efficacy of low intensity vs self-guided psychotherapy for major depression in the Spanish health system.
METHODS: The study is made up of 3 phases: 1.- Development of a computerised cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter controlled, randomized study: A sample (N=450 patients) with mild/moderate depression recruited in primary care. They should have internet availability at home, not receive any previous psychological treatment, and not suffer from any other severe somatic or psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume of health and social services). Patients will be assessed at baseline, 3 and 12 months. An intention to treat and a per protocol analysis will be performed.
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Detailed Description
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Conditions
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Depression
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Low intensity Internet-delivered psychotherapy
Low intensity Internet-delivered psychotherapy + improved treatment as usual by GP.
Group Type
OTHER
Low Intensity Internet-delivered psychotherapy
Intervention Type
OTHER
Patients will be contacted by a researcher trained in psychotherapy. Patients can ask for questions or advice to psychotherapists during the study
Self-guided Internet-delivered psychotherapy
Self-guided Internet-delivered psychotherapy + improved treatment as usual
Group Type
OTHER
Self-guided Internet delivered psychotherapy
Intervention Type
OTHER
No contact with the therapists over the treatment period will be done.
Improved treatment as usual by GP
Group Type
OTHER
Improved treatment as usual
Intervention Type
OTHER
Any kind of treatment administered by the GP to the patient with depression
Interventions
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Low Intensity Internet-delivered psychotherapy
Patients will be contacted by a researcher trained in psychotherapy. Patients can ask for questions or advice to psychotherapists during the study
Intervention Type
OTHER
Self-guided Internet delivered psychotherapy
No contact with the therapists over the treatment period will be done.
Intervention Type
OTHER
Improved treatment as usual
Any kind of treatment administered by the GP to the patient with depression
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of major depression. It will be carried out with MINI International Neuropsychiatric Interview + scoring of moderate or mild depression using Beck Depression Inventory II. Cut-off point for this questionnaire is: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression \[34, 35\].
* Aged 18-65 years
* Able to understand and read Spanish
* Moderate or mild major depression
* Duration of symptoms longer than 2 weeks
* Access to Internet at home and having an email address.
* Aged 18-65 years
* Able to understand and read Spanish
* Moderate or mild major depression
* Duration of symptoms longer than 2 weeks
* Access to Internet at home and having an email address.
Exclusion Criteria
* Any psychological treatment during last year
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Carlos III Health Institute
OTHER_GOV
Sponsor Role
collaborator
Javier Garcia Campayo
OTHER
Sponsor Role
lead
Responsible Party
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Javier Garcia Campayo
Principal Investigator
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Javier García Campayo, PhD
Role: PRINCIPAL_INVESTIGATOR
Miguel Servet Hospital & University of Zaragoza, Spain
Locations
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Hospital Parc Sanitari Sant Joan de Deu
Sant Boi de Llobregat, Barcelona, Spain
Site Status
Health Science Research Institute, University Balearic Islands
Palma de Mallorca, Mallorca, Spain
Site Status
Psychiatric Service. Hospital Vall D'Hebrón
Barcelona, , Spain
Site Status
Psychiatric Service. University Hospital Carlos Haya
Málaga, , Spain
Site Status
Valencia University and CIBER Physiopathology of Obesity and Nutrition. Carlos III Health Institute
Valencia, , Spain
Site Status
Department of Psychiatry. Miguel Servet University Hospital
Zaragoza, , Spain
Site Status
Countries
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Spain
References
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Related Links
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http://www.rediapp.org/
Official website of the Spanish Research Network in Primary Care (Rediapp)
Other Identifiers
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PI10/01083
Identifier Type: -
Identifier Source: org_study_id
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