Major DepressioniCare4DepNCT03623724
iCare4Depression: Effectiveness of a Blended Cognitive-Behavioral Therapy in Routine Practice
A study testing blended Cognitive-behavioral Therapy and Treatment-As-Usual in people with Major Depression, run by University Institute of Maia at 1 site in Portugal.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depression
- What is being tested?
- blended Cognitive-behavioral Therapy and Treatment-As-Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Dec 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years;
- Diagnosis of Major Depression Disorder;
- PHQ-9 score ≥ 9;
- Availability to use the Moodbuster system (online platform and mobile application).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
University Institute of Maia
Maia, Porto District, 4475-690
João Salgado, PhD, 229 866 000, jsalgado@ismai.pt
About this study
Official title: i-Care for Depression: Blending Face-to-face Psychotherapy With Internet and Mobile Digital Solutions
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.
Read the 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.
- Conditions
- Major Depression
- Being tested
- blended Cognitive-behavioral Therapy, Treatment-As-Usual
- Keywords
- Major Depression, Blended Therapy, Randomized Clinical Trials, e-Mental Health, Routine Practice
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blended Cognitive-behavioral TherapyBehavioural
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.
Treatment-As-UsualOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment-As-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Structured Clinical Interview for DSM-5 (First, Williams, Karg, \& Spitzer, 2015). The diagnostic of Major Depression will be performed by a trained psychologist through the Structured Clinical Interview for DSM-5 (First, Williams, Karg, \& Spitzer, 2015). The SCID-5 CV is a structured interview that allows a systematic evaluation of the participants taking into account the classification and diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5; APA, 2013).
Measured: 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
Clinical Outcome Routine Evaluation - Outcome Measure (CORE-OM; Evans, Mellor-Clark, Barkham, \& Mothersole, 2006). The CORE-OM is a self-report questionnaire composed by 34 items that assess global distress and specific dimensions, namely subjective well-being, problems/symptoms, life functioning and risk/harm. Each item is assessed through a Likert scale of five points (0 = not at all; 4 = most or all the time). The total score of this questionnaire can range from 0 to 136 (this score is obtained by adding the response values of each item). The total mean score is calculated by dividing the total score by the number of completed responses. The mean scores for each dimension are calculated by dividing the total scores by the number of completed item responses for each dimension. Higher scores indicate worse results in terms of global distress, but also for the specific dimensions of the questionnaire.
Measured: 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
Generalized Anxiety Disorders (GAD-7; Spitzer, Kroenke, Williams, \& Lowe, 2006). The GAD-7 is composed by seven items that assess the symptoms of generalized anxiety in a Likert scale of four points (0 = Not at all; 3 = Nearly every day). The total score ranges from 0 to 21. A total score between 0 and 4 indicates subclinical symptoms of anxiety; a total score between 5 and 9 indicates mild anxiety; a total score between 10 and 14 indicates moderate anxiety; and a total score between 15 and 21 indicates severe anxiety.
Measured: 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
Working Alliance Inventory-Short Revised (WAI-SR; Tracey \& Kokotovic, 1989). This questionnaire is composed by 12 items, each one scored in a Likert scale of 5 points (1 = rarely or never; 5 = always). This questionnaire measures three dimensions of the therapeutic alliance, namely: (a) agreement between patient and therapist on the goals of the treatment; (b) agreement between patient and therapist about the tasks to achieve these goals; and (c) the quality of the bond between the patient and therapist. In each dimension the total score can range between 5 and 20, and higher scores indicate better therapeutic alliance.
Measured: 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
System Usability Scale (SUS; Brook, 1996). The SUS is a self-report scale composed 10 items rated in a Likert scale of five points (1 = completely disagree; 5 = completely agree) to assess the effectiveness, efficiency and satisfaction regarding the Moosbuster system. The total score of this scale can range from 10 to 50 points.
Measured: 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline
Patients' treatment credibility and expectancy
Credibility and Expectancy Questionnaire (CEQ; Borkovec \& Nau, 1972; Devilly \& Borkovec, 2000). This questionnaire is composed by two sets of items (some ranging from 1 to 9 and others ranging from 0 to 100%) that assess two separate factors, namely treatment expectancy and rationale credibility. Higher results indicate better patients' credibility and expectancy regarding the treatment.
Measured: Baseline assessment
Patients' treatment satisfaction
Client Satisfaction Scale (CSQ-8; Larsen, Attkisson, Hargreaves, \& Nguyen, 1979). This scale evaluate patients' level of satisfaction with treatment. It is composed of eight items, each one evaluated in a Likert scale of four points (1 = low satisfaction; 4 = high satisfaction). The CSQ-8 is scored by summing the individual item scores. The total score can range from 8 to 32, and high scores indicate greater satisfaction with treatment.
Measured: 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline
Change in patients' quality of life from baseline to 52 weeks after baseline
EQ-5D-5L (Brooks \& Euroqol Group, 1996). The EQ-5D-5L is a self-report measure that assesses health-related quality of life taking into account five dimensions: (1) mobility, (2) personal care, (3) usual activities, (4) pain/discomfort, and (5) anxiety/depression. Each dimension is rated in 5 levels: (1) no problems, (2) slight problems, (3) moderate problems, (4) severe problems, and (5) extreme problems. A total of 3125 possible health states can be defined by this scale. This health state may be converted into a single index value. Also, it is possible to obtain, through this measure, a quantitative measure of health. The patient can rate their health in a scale ranging between "the best health you can imagine" and "the worst health you can imagine".
Measured: Baseline assessment; 16 weeks after baseline; 26 weeks after baseline; and 52 weeks after baseline
Assessment of treatment's cost-effectiveness
An equivalent measure to Trimbos/iMTA Questionnaires on Costs Associated with Psychiatric Illness (TiC-P; Roijen, van Straten, Donker, \& Tiemens, 2002) will be used. This measure, under development, will be used to estimate medical costs and indirect non-medical costs associated with productivity losses due to absenteeism and lower efficiency at work in the last 4 weeks.
Measured: Baseline assessment; 16 weeks after baseline; 26 weeks after baseline; and 52 weeks after baseline
Ecological Momentary Assessments
Assessments concerning mood, sleep quality, anxiety and other emotional states that will be collected in a daily basis, in a Likert scale of 7 points.
Measured: 1 week before treatment, during treatment and 1 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start2 Dec 2017
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Institute of Maia
- Sponsor type
- University, hospital or other
- Collaborators
- INESC TEC, University of Limerick, VU University of Amsterdam, Universidade do Porto, ARS - Norte
- Responsible party
- Principal investigator, João Salgado, University Institute of Maia
- Investigators
- João Salgado, PhD, Principal investigator, University Institute of Maia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623724
- Sponsor's protocol ID
- PTDC/MHC-PCL/1991/2014
- Acronym
- iCare4Dep
- Status last verified
- Aug 2018
- First submitted
- 24 Jul 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available to other researchers through scientific publications, manuals, books, conferences and other scientific events.
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- i-Care for Depression: Blending Face-to-face Psychotherapy With Internet and Mobile Digital Solutions
- ClinicalTrials.gov ID
- NCT03623724
- Acronym / sponsor ID
- iCare4Dep / PTDC/MHC-PCL/1991/2014
- Conditions
- Major Depression
- Keywords
- Major Depression, Blended Therapy, Randomized Clinical Trials, e-Mental Health, Routine Practice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Institute of MaiaUniversity, hospital or other
- Collaborators
- INESC TEC, University of Limerick, VU University of Amsterdam, Universidade do Porto, ARS - Norte
- Study start
- 2 Dec 2017 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| blended Cognitive-behavioral Therapy | Experimental | Behavioral: blended Cognitive-behavioral TherapyThe 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. |
| Treatment-As-Usual | Active comparator | Other: Treatment-As-UsualThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years;
- Diagnosis of Major Depression Disorder;
- PHQ-9 score ≥ 9;
- Availability to use the Moodbuster system (online platform and mobile application).
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blended Cognitive-behavioral TherapyThe 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. | Behavioural | blended Cognitive-behavioral Therapy |
| Treatment-As-UsualThe 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). | Other | Treatment-As-Usual |
Primary outcome
Change in depressive symptoms from baseline to 52 weeks after baseline
Time frame: Baseline assessment; therapeutic sessions; 16 weeks after baseline; 26 weeks after baseline; 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.
10 secondary outcomes
Change in the diagnosis of major depression disorder from baseline to 52 weeks after baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline
Patients' treatment credibility and expectancy
Time frame: Baseline assessment
Patients' treatment satisfaction
Time frame: 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline
Change in patients' quality of life from baseline to 52 weeks after baseline
Time frame: Baseline assessment; 16 weeks after baseline; 26 weeks after baseline; and 52 weeks after baseline
Assessment of treatment's cost-effectiveness
Time frame: Baseline assessment; 16 weeks after baseline; 26 weeks after baseline; and 52 weeks after baseline
Ecological Momentary Assessments
Time frame: 1 week before treatment, during treatment and 1 week after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- BackgroundSousa, 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
- Individual participant dataSharing planned: Yes. The data will be available to other researchers through scientific publications, manuals, books, conferences and other scientific events.
Related trials for Major Depression
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João Salgado, PhD principal investigator
University Institute of Maia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blended Cognitive-behavioral Therapy and Treatment-As-Usual in people with Major Depression, run by University Institute of Maia at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact João Salgado, PhD (229 866 000, jsalgado@ismai.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms from baseline to 52 weeks after baseline (time frame: Baseline assessment; therapeutic sessions; 16 weeks after baseline; 26 weeks after baseline; 52 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03623724, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.