scholarly journals A randomised controlled trial of computerised cognitive behaviour therapy for the treatment of depression in primary care: the Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) trial

2015 ◽  
Vol 19 (101) ◽  
pp. 1-174 ◽  
Author(s):  
Elizabeth Littlewood ◽  
Ana Duarte ◽  
Catherine Hewitt ◽  
Sarah Knowles ◽  
Stephen Palmer ◽  
...  
Keyword(s):  
Primary Care ◽  
Cost Effectiveness ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Behaviour Therapy ◽  
Cognitive Behaviour ◽  
Computerised Cognitive Behaviour Therapy ◽  
Randomised Controlled ◽  
Gp Care

BackgroundComputerised cognitive behaviour therapy (cCBT) has been developed as an efficient form of therapy delivery with the potential to enhance access to psychological care. Independent research is needed which examines both the clinical effectiveness and cost-effectiveness of cCBT over the short and longer term.ObjectivesTo compare the clinical effectiveness and cost-effectiveness of cCBT as an adjunct to usual general practitioner (GP) care against usual GP care alone, for a free-to-use cCBT program (MoodGYM; National Institute for Mental Health Research, Australian National University, Canberra, Australia) and a commercial pay-to-use cCBT program (Beating the Blues®; Ultrasis, London, UK) for adults with depression, and to determine the acceptability of cCBT and the experiences of users.DesignA pragmatic, multicentre, three-armed, parallel, randomised controlled trial (RCT) with concurrent economic and qualitative evaluations. Simple randomisation was used. Participants and researchers were not blind to treatment allocation.SettingPrimary care in England.ParticipantsAdults with depression who scored ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9).InterventionsParticipants who were randomised to either of the two intervention groups received cCBT (Beating the Blues or MoodGYM) in addition to usual GP care. Participants who were randomised to the control group were offered usual GP care.Main outcome measuresThe primary outcome was depression at 4 months (PHQ-9). Secondary outcomes were depression at 12 and 24 months; measures of mental health and health-related quality of life at 4, 12 and 24 months; treatment preference; and the acceptability of cCBT and experiences of users.ResultsClinical effectiveness:210 patients were randomised to Beating the Blues, 242 patients were randomised to MoodGYM and 239 patients were randomised to usual GP care (total 691). There was no difference in the primary outcome (depression measured at 4 months) either between Beating the Blues and usual GP care [odds ratio (OR) 1.19, 95% confidence interval (CI) 0.75 to 1.88] or between MoodGYM and usual GP care (OR 0.98, 95% CI 0.62 to 1.56). There was no overall difference across all time points for either intervention compared with usual GP care in a mixed model (Beating the Blues versus usual GP care,p = 0.96; and MoodGYM versus usual GP care,p = 0.11). However, a small but statistically significant difference between MoodGYM and usual GP care at 12 months was found (OR 0.56, 95% CI 0.34 to 0.93). Free-to-use cCBT (MoodGYM) was not inferior to pay-to-use cCBT (Beating the Blues) (OR 0.91, 90% CI 0.62 to 1.34;p = 0.69). There were no consistent benefits of either intervention when secondary outcomes were examined. There were no serious adverse events thought likely to be related to the trial intervention. Despite the provision of regular technical telephone support, there was low uptake of the cCBT programs.Cost-effectiveness:cost-effectiveness analyses suggest that neither Beating the Blues nor MoodGYM appeared cost-effective compared with usual GP care alone.Qualitative evaluation:participants were often demotivated to access the computer programs, by reason of depression. Some expressed the view that a greater level of therapeutic input would be needed to promote engagement.ConclusionsThe benefits that have previously been observed in developer-led trials were not found in this large pragmatic RCT. The benefits of cCBT when added to routine primary care were minimal, and uptake of this mode of therapy was relatively low. There remains a clinical and economic need for effective low-intensity psychological treatments for depression with improved patient engagement.Trial registrationThis trial is registered as ISRCTN91947481.FundingThis project was funded by the National Institute for Health Research Health Technology Assessment programme.

scholarly journals Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial)

2017 ◽  
Vol 21 (24) ◽  
pp. 1-198 ◽  
Author(s):  
Sarah Cockayne ◽  
Sara Rodgers ◽  
Lorraine Green ◽  
Caroline Fairhurst ◽  
Joy Adamson ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Incidence Rate ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Falls Prevention ◽  
Randomised Controlled

BackgroundFalls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care.DesignA pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study.SettingNine NHS trusts in the UK and one site in Ireland.ParticipantsIn total, 1010 participants aged ≥ 65 years were randomised (intervention,n = 493; usual care,n = 517) via a secure, remote service. Blinding was not possible.InterventionsAll participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises.Main outcome measuresThe primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness.ResultsThe primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05;p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00;p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI –£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI –0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants.LimitationsOwing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care.ConclusionsThe intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective.Future workFurther research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients.Trial registrationCurrent Controlled Trials ISRCTN68240461.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 24. See the NIHR Journals Library website for further project information.

FC16-04 - The clinical effectiveness of individual cognitive behaviour therapy for depressed older people in primary care and the use of a talking control (TC)

2011 ◽  
Vol 26 (S2) ◽  
pp. 1907-1907 ◽  
Author(s):  
M.A. Serfaty ◽  
H. Deborah ◽  
M. Buszewicz ◽  
M. Blanchard ◽  
S. Murad ◽  
...  
Keyword(s):  
Primary Care ◽  
Older People ◽  
Cognitive Behaviour Therapy ◽  
Causal Effect ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Behaviour Therapy ◽  
Treatment As Usual ◽  
Cognitive Behaviour ◽  
Specific Factors

ObjectiveTo determine the clinical effectiveness of Cognitive Behaviour Therapy (CBT) delivered in primary care for older people with depression and evaluation of a talking control (TC).MethodsA single-blind, randomized, controlled trial with 4- and 10-month follow-up. 204 people, aged 65 years or more, with a Geriatric Mental State diagnosis of depression were recruited from primary care. The interventions were: treatment as usual (TAU), TAU plus TC, or TAU plus CBT. The TC and CBT were offered over 4 months. The TC was to control for common effects in therapy. The Beck Depression Inventory-II (BDI-II) was the main outcome. Subsidiary measures were the Beck Anxiety Inventory, Social Functioning Questionnaire, and Euroqol. Intention to treat analysis (ITT) and Compliance Average Causal Effect (CACE) analyses was employed. The Cognitive therapy scale (CTS) evaluated common and specific factors in therapy.ResultsA mean of 7 sessions of TC or CBT were delivered. ITT analysis found improvements of −3.07 (95% confidence interval [CI], −5.73 to −0.42) and −3.65 (95% CI, −6.18 to −1.12) in BDI-II scores in favour of CBT vs TAU and TC respectively. CACE analysis found a benefit of 0.4 points (95% CI, 0.01 to 0.72) per therapy session of CBT over TC. Ratings for CBT on the CTS were high (mean [SD], 54.2 [4.1]) and showed no difference for nonspecific, but significant differences for specific factors in therapy.ConclusionCBT is an effective treatment for depressed older people. Improvement appears to be associated with specific factors in CBT.

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