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

NCT03623724 | Unknown

• 1 other identifier: PTDC/MHC-PCL/1991/2014
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression

Keywords

Major Depression; Blended Therapy; Randomized Clinical Trials; e-Mental Health; Routine Practice

Outcome Measures

Primary Outcomes (1)

• Change in depressive symptoms from baseline to 52 weeks after baseline

  Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, \& Williams, 2001). The PHQ-9 is composed by nine items that assess the severity of the depressive symptoms in a Likert scale of four points (0 = Not at all; 3 = Nearly every day). The total score of this questionnaire can range from 0 to 27 points. A total score between 0 and 4 indicates subclinical symptoms of depression; a total score between 5 and 9 indicates mild depression; a total score between 10 and 14 indicates moderate depression; a total score between 15 and 19 indicates moderately severe depression; and a total score between 20 and 27 indicates severe depression.

  Baseline assessment; therapeutic sessions; 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline

Secondary Outcomes (10)

• Change in the diagnosis of major depression disorder from baseline to 52 weeks after baseline

  Baseline assessment; 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline

• Change in the general clinical outcome from baseline to 52 weeks after baseline

  Baseline assessment; therapeutic sessions; 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline

• Change in anxiety symptoms from baseline to 52 weeks after baseline

  Baseline assessment; therapeutic sessions; 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline

• Evolution of the working alliance between therapist and patient during therapeutic sessions and follow-up assessments

  Therapeutic sessions; 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline

• Usability of the Moodbuster system (web platform and smartphone application) for patients and therapists

  16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline

Study Arms (2)

blended Cognitive-behavioral Therapy

EXPERIMENTAL

The experimental condition refers to a blended treatment that integrates empirically-supported face-to-face cognitive-behavioral psychotherapy with a mobile phone application and a web platform - blended cognitive-behavioral therapy (bCBT). The intervention 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. 50 patients will be integrated in this experimental condition.

Behavioral: blended Cognitive-behavioral Therapy

Treatment-As-Usual

ACTIVE COMPARATOR

The control condition concerns the treatment-as-usual (TAU) that consists in routine care that patients receive when they are diagnosed with major depression in primary care. We will not interfere with treatments delivered in TAU, but the intervention will be tracked (e.g., medication). The psychiatrist of our team will monitor possible medicine intake (stabilized throughout the trial). 50 patients will be integrated in this condition.

Other: Treatment-As-Usual

Interventions

blended Cognitive-behavioral Therapy BEHAVIORAL

The protocol includes ten face-to-face cognitive-behavioral sessions combined with nine online sessions based on Moodbuster self-help treatment, delivered over a period of 16 weeks. The Moodbuster includes 7 modules (introduction, psychoeducation, behavioral activation, cognitive restructuring, problem solving, exercise and relapse prevention), a calendar and the possibility of sending and receiving messages to and from therapist, respectively. The mobile phone application will be used to support the therapeutic sessions and register the ecological momentary assessments concerning mood, sleep quality, anxiety and other emotional states that will be collected in a daily basis before, during and after the treatment.

blended Cognitive-behavioral Therapy

Treatment-As-Usual OTHER

The protocol consists in routine care that patients receive when they are diagnosed with major depression in primary care. We will not interfere with treatments delivered in TAU, but the intervention will be tracked (e.g., medication). The psychiatrist of our team will monitor possible medicine intake (stabilized throughout the trial).

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:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Institute of Maia: lead
• INESC TEC: collaborator
• University of Limerick: collaborator
• VU University of Amsterdam: collaborator
• Center of Psychology at University of Porto: collaborator
• ARS - Norte: collaborator

Study Sites (1)

University Institute of Maia

Maia, Porto District, 4475-690, Portugal

RECRUITING

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• João Salgado, PhD

  University Institute of Maia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

João Salgado, PhD

CONTACT

229 866 000; jsalgado@ismai.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 9, 2018
• Study Start: December 2, 2017
• Primary Completion: September 30, 2018
• Study Completion: June 30, 2019
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

PT (1)