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Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression

NCT01611818 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2017-08-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

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

OTHER

Self-guided Internet delivered psychotherapy

No contact with the therapists over the treatment period will be done.

OTHER

Improved treatment as usual

Any kind of treatment administered by the GP to the patient with depression

Sponsors & Collaborators

  • Carlos III Health Institute

    collaborator OTHER_GOV

  • Javier Garcia Campayo

    lead OTHER

Principal Investigators

  • Javier García Campayo, PhD · Miguel Servet Hospital & University of Zaragoza, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-12-31
Completion
2016-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01611818 on ClinicalTrials.gov