Condition category
Mental and Behavioural Disorders
Date applied
26/07/2011
Date assigned
26/07/2011
Last edited
08/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Jo Molle

ORCID ID

Contact details

School of Medicine
Health Policy and Practice
Earlham Road
Norwich
NR4 7TJ
United Kingdom
ccbt@uea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8014

Study information

Scientific title

Acronym

Study hypothesis

The study aims to determine the effectiveness, cost-effectiveness and cost implications of brief vs. extended support given by clinicians vs. assistants as an adjunct to computerised Cognitive Behavioural Therapy (cCBT). It will also examine if such support could be tailored to suit different patients’ needs and preferences in order to achieve optimal clinical outcomes with cCBT within the budget constraints of the NHS. The sample will include 300 patients with non-suicidal depression who are 18 years old or above, are registered with a GP within NHS Norfolk. Suitable patients who agree to participate in the study will be randomly allocated in a 1:1 ratio to an 8-session cCBT programme, called Beating the Blues, which can be accessed via the internet from patients’ homes or at public venues (e.g. libraries, internet cafes). Patients will receive phone support as an adjunct to cCBT either by a clinician (CBT-trained health professional with an active registration) or by an assistant (graduate mental health worker with no clinical qualifications. Support will be provided once a week for the first 6 weeks, once a fortnight for the following 6 weeks and once a month for the following 3 months (a total of 12 phone support sessions over 6 months). The clinician- vs. assistant-supported groups will be further randomised in a 1:1 ratio to receive sessions that are either brief (5-10 min per session) or extended (20-10 min per session). Patients will have a total of 1-2 hrs brief support or 4-6 hrs extended support over 6 months. Data on clinical outcomes (depression and anxiety symptoms, functioning, quality of life) and on healthcare resource and service use will be collected with self-report standardised measures which will be posted to the patients for completion at baseline (week 0) and then at two follow-up points (approx. at weeks 12 and 24 post-randomisation). Interviews will be carried out about patient experiences at approx. 12 weeks post-randomisation.

Ethics approval

09/H0311/98

Study design

Randomised; Interventional; Design type: Process of Care, Screening, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Topic: Mental Health Research Network, Primary Care Research Network for England; Subtopic: Depression, Not Assigned; Disease: Depression

Intervention

cCBT + phone support, The computerised cCBT system used in this study is Beating the Blues (BtB). During eight 50-minute sessions, BtB teaches patients how to identify unhelpful thoughts and come up with helpful alternatives, and how to do activity scheduling, problem-solving and other relevant homework tasks between their computer sessions. Patients are also offered individual support as a single, scheduled, telephone call once a week for the first 6 weeks, then once a fortnight for a subsequent 6 weeks; Follow Up Length: 6 month(s); Study Entry : Single Randomisation only

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

Work & Social Adjustment Scale (WSAS); Timepoint(s): Baseline, 12-weeks, 24-weeks (post-randomisation)

Secondary outcome measures

1. Beck Anxiety Inventory (BAI); Timepoint(s): Baseline, 12-weeks, 24-weeks (post-randomisation)
2. Beck Depression Inventory (BDI); Timepoint(s): Baseline, 12-weeks, 24-weeks (post-randomisation)
3. Baeting the Blue (BtB) individual problem scores; Timepoint(s): At the beginning of every cCBT module
4. BtB single-item anxiety scores; Timepoint(s): At the beginning of every cCBT module
5. BtB single-item depression score; Timepoint(s): At the beginning of every cCBT module
6. BtB suicide scores; Timepoint(s): At the beginning of every cCBT module
7. cCBT system relevance, usefulness and ease of use scores; Timepoint(s): At the end of every cCBT module
8. Computer-Patient Alliance Scale (C-PAS); Timepoint(s): 12 weeks and 24 weeks post-randomisation
9. Generalised Anxiety Disorder-7 item (GAD-7); Timepoint(s): Baseline, 12-weeks, 24-weeks (post-randomisation)
10. BtB versions at beginning of every cCBT module
10.1. Health-Related Quality of Life - EQ-5D; Timepoint(s): Baseline, 12-weeks, 24-weeks (post-randomisation)
10.2. Patient Experience Interview (PEI); Timepoint(s): 12 weeks post randomisation
10.3. Patient Health Questionnaire (PHQ); Timepoint(s): Baseline, 12-weeks, 24-weeks (post-randomisation)
10.4. Depression-9 item (PHQ-9); Timepoint(s): Baseline, 12-weeks, 24-weeks (post-randomisation)
11. BtB versions at beginning of every cCBT module
11.1. Resource & Service Use Questionnaire (RSUQ); Timepoint(s): Baseline, 12 week and 24 week post randomisation
11.2. Therapist-Patient Alliance Scale (T-PAS); Timepoint(s): 12 weeks and 24 weeks post-randomisation

Overall trial start date

01/05/2010

Overall trial end date

30/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

The main criterion for patients to be included in the study is that their primary problem is:
1. Nonsuicidal, nonpsychotic, unipolar mood disorder, such as depression or dysthymia: the key features are low mood, loss of interest/pleasure and/or increased fatigue/low energy for more than 2 weeks. Secondary features can be: feelings of guilt and self-reproach, emotional blunting, loss of confidence, psychomotor retardation or agitation, problems with memory or concentration, changes in weight & appetite, sleep problems, irritability, loss of libido
2. Mixed anxiety and depressive disorder: this condition is very common in primary care and shares key features of both depression (as above) and generalised anxiety (key features: 6 months of tension, worry, apprehension paniclike physical symptoms) but neither cluster of symptoms is clearly predominant and present to the extent that justifies separate diagnoses of a depressive episode or generalised anxiety disorder.
3. Additional inclusion criteria that need to be met so that patients can participate in the study are:
3.1. Signing a written consent form for screening & treatment
3.2. Having a general practitioner (GP) within NHS Norfolk (which does not include Great Yarmouth & Waveney) or being cared for by a service/facility commissioned by NHS Norfolk. In case of University of East Anglia (UEA) students, they would need to have a temporary GP within NHS Norfolk.
3.3. Being 18 years old or above.; Target Gender: Male & Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 300; UK Sample Size: 300

Participant exclusion criteria

1. High current risk of suicide (current suicide plans and intent to harm oneself). In this case, referral to a community mental health or crisis team should be a priority
2. Current psychotic symptoms (due to schizophrenia or bipolar affective disorder or severe depression with psychotic features)
3. Current substance abuse/misuse (alcohol, illicit drugs, tranquilisers) which needs to be addressed as a priority
4. Cognitive impairment which makes difficult the use of a computer, doing homework, etc
5. Any other primary problem (e.g. posttraumaticstress disorder, obsessive compulsive disorder) which needs to be treated as a priority but which may have depression as a comorbid feature

Recruitment start date

01/05/2010

Recruitment end date

30/09/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Medicine
Norwich
NR4 7TJ
United Kingdom

Sponsor information

Organisation

NHS Norfolk (UK)

Sponsor details

Lakeside 400
Old Chapel Way
Broadland Business Park Thorpe St Andrew
Norwich
NR7 0WG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22925596

Publication citations

  1. Protocol

    Gega L, Swift L, Barton G, Todd G, Reeve N, Bird K, Holland R, Howe A, Wilson J, Molle J, Computerised therapy for depression with clinician vs. assistant and brief vs. extended phone support: study protocol for a randomised controlled trial., Trials, 2012, 13, 151, doi: 10.1186/1745-6215-13-151.

Additional files

Editorial Notes