NCT01611818

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Javier Garcia Campayo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Depression

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-12-01
• Completion: 2016-12-01
• First posted: 2012-06-05
• Last updated: 2017-08-10

Locations

6 sites across 1 country: Spain