Clinical trial NCT03623724: iCare4Depression: Effectiveness of a Blended Cognitive-Behavioral Therapy in Routine Practice
Official title: i-Care for Depression: Blending Face-to-face Psychotherapy With Internet and Mobile Digital Solutions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depression
Keywords: Major Depression
Blended Therapy
Randomized Clinical Trials
e-Mental Health
Routine Practice
Lead sponsor: University Institute of Maia
Sponsor class: OTHER
Collaborators: name: INESC TEC
name: University of Limerick
name: VU University of Amsterdam
name: Center of Psychology at University of Porto
name: ARS - Norte
First posted: 2018-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The RCT is composed by an experimental condition and a control condition. In the experimental condition, patients will receive a treatment that integrates face-to-face cognitive-behavioral sessions with online sessions delivered through Moodbuster system (bCBT). In the control condition, patients will receive TAU that consists in routine care that they usually receive in primary care. We will not interfere with treatments delivered in TAU, but the intervention will be tracked, as well as medicine intake. One-hundred patients will be recruited and randomized in two conditions: 50 for bCBT condition and 50 for TAU condition. New cases of Major Depression signaled by GPs or other healthprofessionals will be invited to participate in the RCT. Once obtained the signed informed consent, the patients will be randomized at an individual level. The allocation will be performed by an independent researcher not involved in data collection using an automated computer-based random intergenerator.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Internet-based interventions in depression have emerged over the last decades to improve the access to effective treatments. Despite the increasing relevance of these treatments, empirical evidence is still needed to demonstrate their clinical and cost-effectiveness in different healthcare contexts. The present study represents an extension to the Portuguese context of the original trial developed by the ECOMPARED consortium. The overall project involves 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 (EMA). 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 assessment protocol will be implemented at the baseline, during therapeutic sessions, 16 weeks and 26 weeks after baseline and it is composed by several measures that evaluate depressive symptoms, anxiety symptoms, distress, quality of life, working alliance, treatment credibility and expectancy, treatment satisfaction and system usability. Moreover, the EMA concerning mood, sleep quality, anxiety and other emotional states will be collected in a daily basis before, during and after the treatment. The intervention protocol includes ten face-to-face cognitive-behavioral sessions combined with nine online sessions based on the self-help treatment modules of the Moodbuster (psychoeducation, exercise therapy, behavioral activation, problem solving, cognitive restructuring and relapse prevention) delivered over a period of 16 weeks.

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. The assessment protocol will be implemented at the baseline, during therapeutic sessions, 16 weeks, 26 and 52 weeks after baseline and it is composed by several measures that evaluate depressive symptoms, anxiety symptoms, distress, quality of life, working alliance, treatment credibility and expectancy, treatment satisfaction, system usability and cost-effectiveness. Moreover, the EMA concerning mood, sleep quality, anxiety and other emotional states will be collected in a daily basis before, during and after the treatment. The intervention protocol includes ten face-to-face cognitive-behavioral sessions combined with nine online sessions based on the self-help treatment modules of the Moodbuster (psychoeducation, exercise therapy, behavioral activation, problem solving, cognitive restructuring and relapse prevention) delivered over a period of 16 weeks.

Eligibility criteria: Inclusion Criteria:

* ≥18 years;
* Diagnosis of Major Depression Disorder;
* PHQ-9 score ≥ 9;
* Availability to use the Moodbuster system (online platform and mobile application).

Exclusion Criteria:

* Lack of symptoms for Major Depressive Disorder;
* Lack of proficiency in Portuguese language;
* Not having a computer and/or a smartphone with internet access;
* Presence of severe psychiatric comorbidity requiring alternative treatment, primary to depression treatment;
* High risk of suicide;
* Currently receiving psychotherapy;
* Changes on medication in the last month or plans to change it before the end of the RCT.

Primary outcomes:
measure: Change in depressive symptoms from baseline to 52 weeks after baseline
timeFrame: Baseline assessment; therapeutic sessions; 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline
Secondary outcomes:
measure: Change in the diagnosis of major depression disorder from baseline to 52 weeks after baseline
timeFrame: Baseline assessment; 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline
measure: Change in the general clinical outcome from baseline to 52 weeks after baseline
timeFrame: Baseline assessment; therapeutic sessions; 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline
measure: Change in anxiety symptoms from baseline to 52 weeks after baseline
timeFrame: Baseline assessment; therapeutic sessions; 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline
measure: Evolution of the working alliance between therapist and patient during therapeutic sessions and follow-up assessments
timeFrame: Therapeutic sessions; 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline
measure: Usability of the Moodbuster system (web platform and smartphone application) for patients and therapists
timeFrame: 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline
measure: Patients' treatment credibility and expectancy
timeFrame: Baseline assessment
measure: Patients' treatment satisfaction
timeFrame: 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline
measure: Change in patients' quality of life from baseline to 52 weeks after baseline
timeFrame: Baseline assessment; 16 weeks after baseline; 26 weeks after baseline; and 52 weeks after baseline
measure: Assessment of treatment's cost-effectiveness
timeFrame: Baseline assessment; 16 weeks after baseline; 26 weeks after baseline; and 52 weeks after baseline
measure: Ecological Momentary Assessments
timeFrame: 1 week before treatment, during treatment and 1 week after treatment
Other outcomes:
Locations:
city: Maia
country: Portugal
facility: University Institute of Maia
state: Porto
Study officials:
affiliation: University Institute of Maia
name: João Salgado, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sousa, M., Barbosa, E., Basto, I., Silva, S., Meira, L., Ferreira, T., & Salgado, J. (2018, April). Blended cognitive-behavioral therapy for depression: The iCare4Depression study protocol. Paper presented at 5th ESRII 2018, Dublin, Ireland. https://docs.wixstatic.com/ugd/1d9a38_aacb4271986d492e8fa1317a6207f077.pdf