Plain English Summary
Background and study aims
About a quarter of the UK population will experience some kind of mental health problem in the course of a year, with mixed anxiety and depression as the most common mental disorder. In the UK between 8-12% of the population experience depression in any year. Half of people in need of mental care for depression do not have access to care services, do not always receive evidence-based treatments, or are confronted with long waiting lists. Internet-supported treatments have the potential to address the drawbacks of standard care and keep depression treatment of high quality and affordable. Blending face-to-face treatment with computer-based treatment components is a powerful strategy that may increase the cost-effectiveness of treatment for depression, increase access and decrease waiting times. The primary aims of this study are to assess the acceptability and feasibility of Blended Cognitive Behavioural Therapy (CBT) in IAPT services in the UK, and to compare the clinical and cost-effectiveness of Blended CBT with treatment as usual (TAU) for adults with major depressive disorder (MDD). The secondary aims are to assess the acceptability and satisfaction of the blended approach by patients and therapists, and to assess the therapeutic alliance between patients and therapists in both arms.
Who can participate?
Adult participants with a clinical diagnosis of Major Depression Disorder (MDD). The study will be conducted in community settings, and will recruit participants from Improving Access to Psychological Services (IAPT) in London.
What does the study involve?
Participants will be randomly allocated to either the blended intervention group or the treatment as usual (TAU) group. Internet-based blended depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an internet-based treatment platform with mobile phone components (online CBT). Treatment as usual consists of face-to-face sessions only. The intervention for both groups will last 11 weeks. Outcome questionnaires will be completed by both groups at the start of the study, at the end of treatment (12 weeks), and 6 months and 12 months later, either online or over the phone.
What are the possible benefits and risks of participating?
Participation in this study will help further our understanding of non-medical treatments for depression. This will help us improve the care people with depression receive. Participants may benefit from using the internet platform to learn more about depression and how to manage its symptoms at their own time and pace. This study does not pose a risk to the participating patients.
Where is the study run from?
The London School of Hygiene & Tropical Medicine (UK)
When is the study starting and how long is it expected to run for?
March 2015 to December 2016
Who is funding the study?
European Union Commission, Seventh Framework Programme
Who is the main contact?
Arlinda Cerga-Pashoja
arlinda.cerga-pashoja@lshtm.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Mrs Arlinda Cerga Pashoja
ORCID ID
Contact details
Department of Population Health
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7927 8146
arlinda.cerga-pashoja@lshtm.ac.uk
Type
Scientific
Additional contact
Prof Ricardo Araya
ORCID ID
Contact details
Department of Population Health
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.11
Study information
Scientific title
E-COMPARED - internet-supported CBT for depression: a randomised, pragmatic, feasibility trial
Acronym
E-COMPARED
Study hypothesis
The trial hypothesis is that a computer-supported intervention for depression (face-to-face CBT blended with internet-delivered CBT) will lead to similar (non-inferior) clinical improvements as treatment as usual (face-to-face CBT), but that the blended approach can be more accessible and offered at a significantly lower cost.
Ethics approval
NRES Committee London - Camden & Kings Cross, 17/04/2015, ref: 15/LO/0511
Study design
Pragmatic randomised controlled single-blind parallel-group non-inferiority feasibility trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Major depressive disorder
Intervention
Participants will be randomly allocated to the blended intervention arm or the treatment as usual (TAU) arm.
The trial intervention is a blended approach of face-to-face Cognitive Behaviour Therapy (CBT) for depression with internet-delivered CBT. The internet-based intervention will be supported by a platform called MoodBuster that comprises three elements:
1. A web-based interface providing the patients with access to CBT
2. A web-based portal for therapists, where they can view patient progress and give feedback
3. A mobile phone component which enables daily EMA monitoring of mood state, cognitions, activities, social interaction, and sleep of the patients.
The core components of the CBT treatment are:
1. Psycho-education
2. Cognitive restructuring
3. Behavioural activation
4. Relapse prevention
Blended depression treatment will be provided by IAPT therapists who will receive training on how to deliver the treatment.
Treatment as usual consists of face-to-face sessions only. The intervention for both arms will last 11 weeks.
Intervention type
Other
Phase
Drug names
Primary outcome measure
The primary outcome measure will be Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a nine-item mood module that can be used to screen and to diagnose patients with depressive disorders. Outcomes will be measured on both arms at baseline, end of treatment (12 weeks), 6 months and 12 months.
Secondary outcome measures
1. MINI - A diagnosis of depression will be assessed with the MINI International Neuropsychiatric Interview (M.I.N.I) version 5.0.
2. QIDS - The 16-item self-report version of the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR) US Translation (Rush et al., 2003) is used in addition to the PHQ-9 because it is a promising questionnaire for assessing depressive symptoms.
3. Quality-adjusted life-years (QALYs) will be assessed with the EQ-5D-5L (EuroQol).
4. TiC-P - Health service uptake and loss of productivity due to illness, which allow us to estimate indirect economic costs, is measured with the Trimbos and iMTA Questionnaires on Costs Associated with Psychiatric Illness.
5. WAI -The therapeutic alliance between therapists and patient will be assessed with the short version of the Working Alliance Inventory.
6. CEQ - Patients’ expectancy of treatment will be assessed with the Credibility and Expectancy Questionnaire.
7. CSQ-8 - Patient’s satisfaction with the treatment will be assessed with Client Satisfaction Questionnaire.
8. SUS - Satisfaction with the platform will be evaluated with the system usability scale.
9. HAq-II – The Helping Alliance questionnaire is a widely used questionnaire that measures the strength of the therapeutic alliance between the therapist and the patient.
Outcomes will be measured on both arms at baseline, end of treatment (12 weeks), 6 months and 12 months.
Overall trial start date
23/03/2015
Overall trial end date
31/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 18 years of age or older
2. Scoring more than 5 points on PHQ-9
3. Meet DSM-IV diagnostic criteria for Major Depression Disorder as confirmed by the telephone administered MINI International Neuropsychiatric Interview version 5.0
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Current high risk for suicide according to the MINI Interview section C
2. Serious psychiatric co-morbidity that requires alternative treatment including substance dependence, bipolar affective disorder, psychotic illness or obsessive compulsive disorder as established at the MINI interview
3. Currently receiving psychological treatment for depression in primary or specialised mental health care
4. Being unable to comprehend, speak, read or write English
5. Not having access to a fast internet connection (i.e., broadband or comparable)
6. Not having or being unable to set up an email address that can be used to communicate with the therapist and research team
Recruitment start date
06/04/2015
Recruitment end date
01/10/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
London School of Hygiene and Tropical Medicine
WC1E 7HT
United Kingdom
Trial participating centre
Camden and Islington NHS Foundation Trust
NW1 0PE
United Kingdom
Sponsor information
Organisation
London School of Hygiene and Tropical Medicine
Sponsor details
Department of Population Health
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7927 8146
arlinda.cerga-pashoja@lshtm.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Seventh Framework Programme
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Results and Publications
Publication and dissemination plan
The trial will be published in peer-reviewed medical journals to be confirmed at a later date. Abstracts will be submitted to identified relevant conferences to inform other researchers of the work.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27488181