Clinical trial NCT01611818: Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression
Official title: Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression: a Multicenter, Controlled, Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Computer-delivered psychotherapy
Randomized-controlled trial
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
First posted: 2012-06-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Severity of depressive symptomatology measured by Beck Depression Inventory II
timeFrame: At baseline
measure: Severity of depressive symptomatology measured by Beck Depression Inventory II
timeFrame: After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program.
measure: Severity of depressive symptomatology measured by Beck Depression Inventory II
timeFrame: 3 months after completing the psychotherapy program
measure: Severity of depressive symptomatology measured by Beck Depression Inventory II
timeFrame: 12 months after completing the psychotherapy program
Secondary outcomes:
measure: Socio-demographic variables.
timeFrame: At Baseline
measure: Mini-International Neuropsychiatric Interview (MINI).
timeFrame: At Baseline
measure: EuroQoL-5D questionnaire (EQ-5D - Spanish version)
timeFrame: At Baseline
measure: Client Service Receipt Inventory - adapted (CSRI - Spanish version)
timeFrame: At baseline
measure: Overall Depression Severity and Impairment Scale
timeFrame: At baseline
measure: Positive and Negative Affect Scale (PANAS)
timeFrame: At Baseline
measure: Credibility/expectancy questionnaire
timeFrame: At Baseline
measure: EuroQoL-5D questionnaire (EQ-5D - Spanish version)
timeFrame: After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program.
measure: EuroQoL-5D questionnaire (EQ-5D - Spanish version)
timeFrame: 3 months after completing the psychotherapy program
measure: EuroQoL-5D questionnaire (EQ-5D - Spanish version)
timeFrame: 12 months after completing the psychotherapy program
measure: Client Service Receipt Inventory - adapted (CSRI - Spanish version)
timeFrame: After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program
measure: Client Service Receipt Inventory - adapted (CSRI - Spanish version)
timeFrame: 3 months after completing the psychotherapy program
measure: Client Service Receipt Inventory - adapted (CSRI - Spanish version)
timeFrame: 12 months after completing the psychotherapy program
measure: Overall Depression Severity and Impairment Scale
timeFrame: After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program.
measure: Overall Depression Severity and Impairment Scale
timeFrame: 3 months after completing the psychotherapy program
measure: Overall Depression Severity and Impairment Scale
timeFrame: 12 months after completing the psychotherapy program
measure: Positive and Negative Affect Scale (PANAS)
timeFrame: After the Internet-delivered psychotherapy program has been finished. We estimate 3 months on average to complete the program.
measure: Positive and Negative Affect Scale (PANAS)
timeFrame: 3 months after completing the psychotherapy program
measure: Positive and Negative Affect Scale (PANAS)
timeFrame: 12 months after completing the psychotherapy program
Other outcomes:
Locations:
city: Sant Boi de Llobregat
country: Spain
facility: Hospital Parc Sanitari Sant Joan de Deu
state: Barcelona
city: Palma de Mallorca
country: Spain
facility: Health Science Research Institute, University Balearic Islands
state: Mallorca
city: Barcelona
country: Spain
facility: Psychiatric Service. Hospital Vall D'Hebrón
city: Málaga
country: Spain
facility: Psychiatric Service. University Hospital Carlos Haya
city: Valencia
country: Spain
facility: Valencia University and CIBER Physiopathology of Obesity and Nutrition. Carlos III Health Institute
city: Zaragoza
country: Spain
facility: Department of Psychiatry. Miguel Servet University Hospital
Study officials:
affiliation: Miguel Servet Hospital & University of Zaragoza, Spain
name: Javier García Campayo, PhD
role: PRINCIPAL_INVESTIGATOR
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