Topic: Mental Health Research Network, Primary Care Research Network for England
Conditions
Interventions
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 w
Study Entry : Single Randomisation only
Sponsors
NHS Norfolk (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Work & Social Adjustment Scale (WSAS); Timepoint(s): Baseline, 12-weeks, 24-weeks (post-randomisation) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed