Individualised patient support as an adjunct to computerised selfhelp for depression: factorial randomised controlled trial of brief vs. extended support given by clinicians vs. assistants
| ISRCTN | ISRCTN98677176 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98677176 |
| Secondary identifying numbers | 8014 |
- Submission date
- 26/07/2011
- Registration date
- 26/07/2011
- Last edited
- 26/09/2018
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Jo Molle
Scientific
Scientific
School of Medicine
Health Policy and Practice
Earlham Road
Norwich
NR4 7TJ
United Kingdom
| ccbt@uea.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Process of Care, Screening, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | Individualised patient support as an adjunct to computerised selfhelp for depression: factorial randomised controlled trial of brief vs. extended support given by clinicians vs. assistants |
| Study objectives | 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(s) | 09/H0311/98 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2010 |
| Completion date | 30/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 300; UK Sample Size: 300 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2010 |
| Date of final enrolment | 30/09/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Medicine
Norwich
NR4 7TJ
United Kingdom
NR4 7TJ
United Kingdom
Sponsor information
NHS Norfolk (UK)
Hospital/treatment centre
Hospital/treatment centre
Lakeside 400
Old Chapel Way
Broadland Business Park Thorpe St Andrew
Norwich
NR7 0WG
England
United Kingdom
"ROR" |
https://ror.org/01wspv808 |
|---|
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/08/2012 | Yes | No |
Editorial Notes
26/09/2018: No publications found, verifying study status with principal investigator.
