NCT03623724: iCare4Dep

iCare4Depression: Effectiveness of a Blended Cognitive-Behavioral Therapy in Routine Practice

Status unknown NA Last updated 9 August 2018

What this trial tests

NA trial testing blended Cognitive-behavioral Therapy in Major Depression in 100 participants. Status unknown.

Timeline

2 December 2017

Primary endpoint
30 September 2018

30 June 2019

Quick facts

Lead sponsor	University Institute of Maia
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	2 December 2017
Primary completion	30 September 2018
Estimated completion	30 June 2019
Sites	1 location across Portugal

Drugs / interventions tested

• blended Cognitive-behavioral Therapy
• Treatment-As-Usual

Conditions studied

• Major Depression — all drugs for Major Depression →

Sponsor

University Institute of Maia

Who can join

18 and older, any sex, with Major Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main objective of this research project is to implement and evaluate the clinical effectiveness and cost-effectiveness of a Blended Cognitive-Behavioral Therapy (bCBT) in routine practice, comparing it with Treatment as Usual (TAU). This research project includes a pilot study and a randomized clinical trial (RCT).

The pilot study main objective is to adapt the bCBT based on Moodbuster, an internet-based treatment platform developed by the ICT4Depression Consortium (INESC-TEC, Vrije Universiteit and University of Limerick), to the Portuguese population. More specifically, this pilot study intends: (1) to detect problems and refine procedures, establishing a definitive Portuguese version of the blended treatment; (2) to assess clinical effectiveness (non-controlled), estimating effect sizes at the end of the treatment and follow-up; (3) to assess patients' satisfaction and personal views concerning their process of change; (4) to develop dynamic models of the individual trajectories during treatment based on Ecological Momentary Assessments. The pilot study will involve the participation of psychologists trained in bCBT and 20 participants diagnosed with Major Depression and willing to use the Moodbuster system.

The RCT is composed by two arms (an experimental condition and a control condition) and it will be implemented in routine practice. In the experimental condition, the patients diagnosed with Major Depression will receive a treatment that integrates face-to-face cognitive-behavioral sessions with online sessions available through Moodbuster system (bCBT). In the control condition, patients diagnosed with Major Depression will receive TAU that consists in routine care that patients receive in primary care. The RCT will involve the participation of family doctors and psychologists working in routine practice. One-hundred patients will be recruited and randomized in the two conditions: 50 patients for bCBT condition and 50 patients for TAU condition. The main objectives are: (1) to assess the clinical effectiveness of bCBT and compare it with TAU in routine practice; (2) to estimate and compare cost-effectiveness of both treatments; (3) to assess patients' and clinicians' satisfaction with the bCBT and TAU; (4) to refine the previous models of individual trajectories and to assess differential effects on different patient clusters; (5) to establish guidelines for using bCBT within Portuguese routine practice services.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.