ISRCTN ISRCTN12388725
DOI https://doi.org/10.1186/ISRCTN12388725
ClinicalTrials.gov number NCT02542891, NCT02389660, NCT02361684, NCT02449447, NCT02410616, NCT02796573
Secondary identifying numbers DRKS00006866, NTR4962
Submission date
20/03/2015
Registration date
19/05/2015
Last edited
09/06/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Study website

Contact information

Mrs Arlinda Cerga Pashoja
Public

Department of Population Health
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Phone +44 (0)20 7927 8146
Email arlinda.cerga-pashoja@lshtm.ac.uk
Prof Ricardo Araya
Scientific

Department of Population Health
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Study information

Study designPragmatic randomized controlled single-blind parallel-group non-inferiority feasibility trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Community
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleE-COMPARED - internet-supported CBT for depression: a randomised, pragmatic, feasibility trial
Study acronymE-COMPARED
Study objectivesThe 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(s)NRES Committee London - Camden & Kings Cross, 17/04/2015, ref: 15/LO/0511
Health condition(s) or problem(s) studiedMajor depressive disorder
InterventionParticipants 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 typeOther
Primary outcome measureThe 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 measures1. 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 study start date23/03/2015
Completion date31/12/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants150
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment06/04/2015
Date of final enrolment01/10/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

London School of Hygiene and Tropical Medicine
WC1E 7HT
United Kingdom
Camden and Islington NHS Foundation Trust
NW1 0PE
United Kingdom

Sponsor information

London School of Hygiene and Tropical Medicine
University/education

Department of Population Health
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
England
United Kingdom

Phone +44 (0)20 7927 8146
Email arlinda.cerga-pashoja@lshtm.ac.uk
ROR logo "ROR" https://ror.org/00a0jsq62

Funders

Funder type

Government

Seventh Framework Programme
Government organisation / National government
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe 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.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article 03/08/2016 Yes No
Results article Qualitative working alliance results 23/09/2020 25/09/2020 Yes No
Results article Practitioners' experience of the working alliance 25/07/2022 26/07/2022 Yes No
HRA research summary 28/06/2023 No No
Other publications Secondary analysis 31/05/2024 03/06/2024 Yes No
Other publications Secondary analysis 21/03/2022 09/06/2025 Yes No

Editorial Notes

09/06/2025: Publication reference added.
03/06/2024: Publication reference added.
26/07/2022: Publication reference added.
25/09/2020: Publication reference added.
05/08/2016: Publication reference added.
30/03/2016: Ethics approval information added.