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

NCT01611818 | Completed

• 1 other identifier: PI10/01083
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 6

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.

Conditions

Depression

Keywords

Depression; Computer-delivered psychotherapy; Randomized-controlled trial

Outcome Measures

Primary Outcomes (4)

• Severity of depressive symptomatology measured by Beck Depression Inventory II

  This is one of the most widely questionnaires used to evaluate severity of depression in pharmacological and psychotherapy trials. This questionnaire has been used because it is recommended to assess depression in primary care patients in which comorbidity with medical disorders is frequent. The Spanish validated version of the questionnaire will be used.

  At baseline

• Severity of depressive symptomatology measured by Beck Depression Inventory II

  This is one of the most widely questionnaires used to evaluate severity of depression in pharmacological and psychotherapy trials. This questionnaire has been used because it is recommended to assess depression in primary care patients in which comorbidity with medical disorders is frequent. The Spanish validated version of the questionnaire will be used.

  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

  This is one of the most widely questionnaires used to evaluate severity of depression in pharmacological and psychotherapy trials. This questionnaire has been used because it is recommended to assess depression in primary care patients in which comorbidity with medical disorders is frequent. The Spanish validated version of the questionnaire will be used.

  3 months after completing the psychotherapy program

• Severity of depressive symptomatology measured by Beck Depression Inventory II

  This is one of the most widely questionnaires used to evaluate severity of depression in pharmacological and psychotherapy trials. This questionnaire has been used because it is recommended to assess depression in primary care patients in which comorbidity with medical disorders is frequent. The Spanish validated version of the questionnaire will be used.

  12 months after completing the psychotherapy program

Secondary Outcomes (19)

• Socio-demographic variables.

  At Baseline

• Mini-International Neuropsychiatric Interview (MINI).

  At Baseline

• EuroQoL-5D questionnaire (EQ-5D - Spanish version)

  At Baseline

• Client Service Receipt Inventory - adapted (CSRI - Spanish version)

  At baseline

• Overall Depression Severity and Impairment Scale

  At baseline

Study Arms (3)

Low intensity Internet-delivered psychotherapy

OTHER

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

Other: Low Intensity Internet-delivered psychotherapy

Self-guided Internet-delivered psychotherapy

OTHER

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

Other: Self-guided Internet delivered psychotherapy

Improved treatment as usual by GP

OTHER

Other: Improved treatment as usual

Interventions

Low Intensity Internet-delivered psychotherapy OTHER

Patients will be contacted by a researcher trained in psychotherapy. Patients can ask for questions or advice to psychotherapists during the study

Low intensity Internet-delivered psychotherapy

Self-guided Internet delivered psychotherapy OTHER

No contact with the therapists over the treatment period will be done.

Self-guided Internet-delivered psychotherapy

Improved treatment as usual OTHER

Any kind of treatment administered by the GP to the patient with depression

Improved treatment as usual by GP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any psychological treatment during last year

Sponsors & Collaborators

• Javier Garcia Campayo: lead
• Carlos III Health Institute: collaborator

Study Sites (6)

Hospital Parc Sanitari Sant Joan de Deu

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Health Science Research Institute, University Balearic Islands

Palma de Mallorca, Mallorca, Spain

Location

Psychiatric Service. Hospital Vall D'Hebrón

Barcelona, 08035, Spain

Location

Psychiatric Service. University Hospital Carlos Haya

Málaga, 29010, Spain

Location

Valencia University and CIBER Physiopathology of Obesity and Nutrition. Carlos III Health Institute

Valencia, Spain

Location

Department of Psychiatry. Miguel Servet University Hospital

Zaragoza, 50009, Spain

Location

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Related Links

• Official website of the Spanish Research Network in Primary Care (Rediapp)

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Javier García Campayo, PhD

  Miguel Servet Hospital & University of Zaragoza, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: June 5, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: August 10, 2017

Record last verified: 2017-08

Locations

ES (6)