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

Depression research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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. Exclusion Criteria: - Any psychological treatment during last year - Severe psychiatric disorder in Axis I (alcohol/substances abuse or dependence, psychotic disorders or dementia)patients with severe depression (indicated by a Beck-II score of 29 or higher) who will be advised to consult their GP Receiving pharmacological treatment with antidepressants is not an exclusion criteria meanwhile, during the study period, treatment will not be modified or increased (decrease of pharmacological treatment is accepted).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Low Intensity Internet-delivered psychotherapyPatients 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 psychotherapyNo contact with the therapists over the treatment period will be done.

Other:Improved treatment as usualAny kind of treatment administered by the GP to the patient with depression

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Low intensity Internet-delivered psychotherapyLow intensity Internet-delivered psychotherapy + improved treatment as usual by GP.

Self-guided Internet-delivered psychotherapySelf-guided Internet-delivered psychotherapy + improved treatment as usual

Improved treatment as usual by GP

Study Status

Completed

Start Date: September 2012

Completed Date: December 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Severity of depressive symptomatology measured by Beck Depression Inventory II

Secondary Outcome: Socio-demographic variables.

Study sponsors, principal investigator, and references

Principal Investigator: Javier García Campayo, PhD

Lead Sponsor: Javier Garcia Campayo

Collaborator: Carlos III Health Institute

More information:https://clinicaltrials.gov/show/NCT01611818

Fernández A, Saameño JA, Pinto-Meza A, Luciano JV, Autonell J, Palao D, Salvador-Carulla L, Campayo JG, Haro JM, Serrano A; DASMAP investigators. Burden of chronic physical conditions and mental disorders in primary care. Br J Psychiatry. 2010 Apr;196(4):302-9. doi: 10.1192/bjp.bp.109.074211.

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