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

Javier Garcia Campayo

Status: Completed

Conditions: Depression

Treatments: Other: Improved treatment as usual; Other: Low Intensity Internet-delivered psychotherapy; Other: Self-guided Internet delivered psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01611818

PI10/01083

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

Low intensity Internet-delivered psychotherapy

Other group

Description:

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

Treatment:

Other: Low Intensity Internet-delivered psychotherapy

Self-guided Internet-delivered psychotherapy

Other group

Description:

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

Treatment:

Other: Self-guided Internet delivered psychotherapy

Improved treatment as usual by GP

Other group

Treatment:

Other: Improved treatment as usual