Overview

This trial is active, not recruiting.

Condition depression
Treatments low intensity internet-delivered psychotherapy, self-guided internet delivered psychotherapy, improved treatment as usual
Sponsor Javier Garcia Campayo
Collaborator Carlos III Health Institute
Start date September 2012
End date December 2014
Trial size 450 participants
Trial identifier NCT01611818, PI10/01083

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Other)
Low intensity Internet-delivered psychotherapy + improved treatment as usual by GP.
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 + improved treatment as usual
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

Primary Outcomes

Measure
Severity of depressive symptomatology measured by Beck Depression Inventory II
time frame: At baseline
Severity of depressive symptomatology measured by Beck Depression Inventory II
time frame: After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program.
Severity of depressive symptomatology measured by Beck Depression Inventory II
time frame: 3 months after completing the psychotherapy program
Severity of depressive symptomatology measured by Beck Depression Inventory II
time frame: 12 months after completing the psychotherapy program

Secondary Outcomes

Measure
Socio-demographic variables.
time frame: At Baseline
Mini-International Neuropsychiatric Interview (MINI).
time frame: At Baseline
EuroQoL-5D questionnaire (EQ-5D - Spanish version)
time frame: At Baseline
Client Service Receipt Inventory - adapted (CSRI - Spanish version)
time frame: At baseline
Overall Depression Severity and Impairment Scale
time frame: At baseline
Positive and Negative Affect Scale (PANAS)
time frame: At Baseline
Credibility/expectancy questionnaire
time frame: At Baseline
EuroQoL-5D questionnaire (EQ-5D - Spanish version)
time frame: After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program.
EuroQoL-5D questionnaire (EQ-5D - Spanish version)
time frame: 3 months after completing the psychotherapy program
EuroQoL-5D questionnaire (EQ-5D - Spanish version)
time frame: 12 months after completing the psychotherapy program
Client Service Receipt Inventory - adapted (CSRI - Spanish version)
time frame: After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program
Client Service Receipt Inventory - adapted (CSRI - Spanish version)
time frame: 3 months after completing the psychotherapy program
Client Service Receipt Inventory - adapted (CSRI - Spanish version)
time frame: 12 months after completing the psychotherapy program
Overall Depression Severity and Impairment Scale
time frame: After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program.
Overall Depression Severity and Impairment Scale
time frame: 3 months after completing the psychotherapy program
Overall Depression Severity and Impairment Scale
time frame: 12 months after completing the psychotherapy program
Positive and Negative Affect Scale (PANAS)
time frame: After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program.
Positive and Negative Affect Scale (PANAS)
time frame: 3 months after completing the psychotherapy program
Positive and Negative Affect Scale (PANAS)
time frame: 12 months after completing the psychotherapy program

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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).

Additional Information

Official title Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression: a Multicenter, Controlled, Randomised Study
Principal investigator Javier García Campayo, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Hospital Miguel Servet.