CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 300 enrolled
Drug / intervention
Low Intensity Internet-delivered psychotherapy +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01611818
NCT01611818N/ACompleted

Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression: a Multicenter, Controlled, Randomised Study

Javier Garcia Campayo·interventional·Posted Jun 5, 2012·Updated Aug 10, 2017

In Brief

A clinical study evaluating Low Intensity Internet-delivered psychotherapy, Self-guided Internet delivered psychotherapy, and 1 other intervention for Depression. Completed, enrolled 300 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesSpain

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 5, 2012
Enrollment StartSep 1, 2012
Primary CompletionDec 1, 2014
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.1 years ago

Interventions

Low Intensity Internet-delivered psychotherapyother

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 psychotherapyother

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

Improved treatment as usualother

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