e-Compared-S: Comparative Effectiveness Research on Internet-based Depression Treatment - Spanish Trial

NCT02361684 | Completed DMC

• 1 other identifier: UJaumeI07
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

To compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU) in Spanish population.

Conditions

Major Depressive Disorder

Keywords

cost-effectiveness; blended treatment; Internet based treatment; Efficacy; Depression; cognitive behavioural therapy

Outcome Measures

Primary Outcomes (1)

• Change in Patient Health Questionnaire-9

  The PHQ-9 is a nine-item mood module that can be used to screen and to diagnose patients with depressive disorders. The 9 items are each scored on a 0-3 scale with the total score ranging from 0-27 and higher scores indicating more severe depression. The PHQ-9 has shown to have good psychometric properties (Wittkampf, Naeije, Schene, Huyser, \& van Weert, 2007).

  Baseline, 3 months, 6 months and 12 months

Secondary Outcomes (8)

• Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR) US Translation

  Baseline, 3 months, 6 months and 12 months

• Change in the MINI International Neuropsychiatric Interview (M.I.N.I) version 5.0

  Baseline and 12 months

• Change in the EQ-5D-5L (EuroQol)

  Baseline, 3 months, 6 months and 12 months

• Change in the Questionnaires on Costs Associated with Psychiatric Illness (TiC-P; Hakkaart-van Rooijen, van Straten, Donker, Tiemens, 2002)

  Baseline, 3 months, 6 months and 12 months

• Change in the Working Alliance Inventory (WAI-SF)

  3 months

Study Arms (2)

Blended CBT treatment

EXPERIMENTAL

Behavioral: Blended CBT treatment

Treatment as usual

ACTIVE COMPARATOR

Other: Treatment as usual

Interventions

Blended CBT treatment BEHAVIORAL

Internet based blended CBT depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile phone components (either integrated in the treatment platform or as a separate system). The core components of the CBT treatment are: (1) psycho-education, (2) cognitive restructuring, (3) behavioural activation, (4) positive psychology, and (5) relapse prevention. These will be delivered over 10 sessions. For this study, the ratio between the number of face-to-face sessions and the number of online module will be 1/3 face-to-face and 2/3 online.

Blended CBT treatment

Treatment as usual OTHER

Treatment as usual (TAU) is defined as the routine care that subjects receive when they are diagnosed with depression in the primary care system. In practice, this means that treatment as usual may vary between patients. We will not interfere with treatment as usual but we will monitor carefully which health care services are utilized by usual care patients using patient records and through self-report

Treatment as usual

Eligibility Criteria

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

You may qualify if:

• Being 18 years of age or older
• Meet DSM-IV diagnostic criteria for MDD confirmed by MINI International Neuropsychiatric Interview version 5.0
• a score a score of 5 or higher on the PHQ-9 screening questionnaire.

You may not qualify if:

• Current high risk for suicide according to the MINI Interview section C
• Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview
• Currently receiving psychological treatment for depression in primary or specialised mental health care
• Being unable to comprehend the spoken and written language (Spanish)
• Not having access to a PC and fast Internet connection (i.e. broadband or comparable).
• Not having a Smartphone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone during the duration of treatment

Sponsors & Collaborators

• Universitat Jaume I: lead
• University of Valencia: collaborator

Study Sites (2)

University Jaume I

Castellon, Castellón, 12071, Spain

Location

University of Valencia

Valencia, 46010, Spain

Location

Related Publications (27)

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MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Cristina Botella Arbona, PhD

  Universitat Jaume I;CIBERObn ISC III, Castellón de la Plana, Spain

  PRINCIPAL INVESTIGATOR

• Rosa Baños Rivera, PhD

  Universitat de Valencia; CIBERObn ISC III, Castellón de la Plana, Spain

  PRINCIPAL INVESTIGATOR

• Azucena García-Palacios, PhD

  Universitat Jaume I;CIBERObn ISC III, Castellón de la Plana, Spain

  PRINCIPAL INVESTIGATOR

• Ernestina Etchemendy, PhD

  CIBERObn ISC III, Castellón de la Plana, Spain

  PRINCIPAL INVESTIGATOR

• Rocio Herrero Camarano, PhD

  Universitat Jaume I

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: February 12, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

ES (2)