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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22925596
Publication citations
-
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.