The clinical and cost effectiveness of cognitive behavioural therapy plus treatment as usual for the treatment of depression in advanced cancer (CanTalk): study protocol for a randomised controlled trial

BackgroundAnxiety is common and problematic in dementia, yet there is a lack of effective treatments.AimsTo develop a cognitive–behavioural therapy (CBT) manual for anxiety in dementia and determine its feasibility through a randomised controlled trial.MethodA ten-session CBT manual was developed. Participants with dementia and anxiety (and their carers) were randomly allocated to CBT plus treatment as usual (TAU) (n= 25) or TAU (n= 25). Outcome and cost measures were administered at baseline, 15 weeks and 6 months.ResultsAt 15 weeks, there was an adjusted difference in anxiety (using the Rating Anxiety in Dementia scale) of (–3.10, 95% CI −6.55 to 0.34) for CBT compared with TAU, which just fell short of statistical significance. There were significant improvements in depression at 15 weeks after adjustment (–5.37, 95% CI −9.50 to −1.25). Improvements remained significant at 6 months. CBT was cost neutral.ConclusionsCBT was feasible (in terms of recruitment, acceptability and attrition) and effective. A fully powered RCT is now required.

Download Full-text

Protocol investigating the clinical outcomes and cost-effectiveness of cognitive–behavioural therapy delivered remotely for unscheduled care users with health anxiety: randomised controlled trial

BJPsych Open ◽

10.1192/bjpo.bp.115.002220 ◽

2016 ◽

Vol 2 (1) ◽

pp. 81-87 ◽

Cited By ~ 6

Author(s):

Shireen Patel ◽

Sam Malins ◽

Boliang Guo ◽

Marilyn James ◽

Joe Kai ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Clinical Outcomes ◽

Cognitive Behavioural Therapy ◽

Controlled Trial ◽

Health Anxiety ◽

Behavioural Therapy ◽

Unscheduled Care ◽

Cognitive Behavioural ◽

Randomised Controlled

BackgroundHealth anxiety and medically unexplained symptoms cost the National Health Service (NHS) an estimated £3 billion per year in unnecessary costs with little evidence of patient benefit. Effective treatment is rarely taken up due to issues such as stigma or previous negative experiences with mental health services. An approach to overcome this might be to offer remotely delivered psychological therapy, which can be just as effective as face-to-face therapy and may be more accessible and suitable.AimsTo investigate the clinical outcomes and cost-effectiveness of remotely delivered cognitive–behavioural therapy (CBT) to people with high health anxiety repeatedly accessing unscheduled care (trial registration: NCT02298036).MethodA multicentre randomised controlled trial (RCT) will be undertaken in primary and secondary care providers of unscheduled care across the East Midlands. One hundred and forty-four eligible participants will be equally randomised to receive either remote CBT (6–12 sessions) or treatment as usual (TAU). Two doctoral research studies will investigate the barriers and facilitators to delivering the intervention and the factors contributing to the optimisation of therapeutic outcome.ResultsThis trial will be the first to test the clinical outcomes and cost-effectiveness of remotely delivered CBT for the treatment of high health anxiety.ConclusionsThe findings will enable an understanding as to how this intervention might fit into a wider care pathway to enhance patient experience of care.

Download Full-text

Clinical and cost-effectiveness of one-session treatment (OST) versus multisession cognitive–behavioural therapy (CBT) for specific phobias in children: protocol for a non-inferiority randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-025031 ◽

2018 ◽

Vol 8 (8) ◽

pp. e025031 ◽

Cited By ~ 3

Author(s):

Barry D Wright ◽

Cindy Cooper ◽

Alexander J Scott ◽

Lucy Tindall ◽

Shehzad Ali ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Cognitive Behavioural Therapy ◽

Controlled Trial ◽

Behavioural Therapy ◽

Alternative Methods ◽

Cognitive Behavioural ◽

Life Years ◽

Specific Phobias ◽

Randomised Controlled

IntroductionSpecific phobias (intense, enduring fears of an object or situation that lead to avoidance and severe distress) are highly prevalent among children and young people. Cognitive–behavioural therapy (CBT) is a well-established, effective intervention, but it can be time consuming and costly because it is routinely delivered over multiple sessions during several months. Alternative methods of treating severe and debilitating phobias in children are needed, like one-session treatment (OST), to reduce time and cost, and to prevent therapeutic drift and help children recover quickly. Our study explores whether (1) outcomes with OST are ‘no worse’ than outcomes with multisession CBT, (2) OST is acceptable to children, their parents and the practitioners who use it and (3) OST offers good value for money to the National Health Service (NHS) and to society.MethodA pragmatic, non-inferiority, randomised controlled trial will compare OST with multisession CBT-based therapy on their clinical and cost-effectiveness. The primary clinical outcome is a standardised behavioural task of approaching the feared stimulus at 6 months postrandomisation. The outcomes for the within-trial cost-effectiveness analysis are quality-adjusted life years based on EQ-5D-Y, and individual-level costs based of the intervention and use of health and social service care. A nested qualitative evaluation will explore children’s, parents’ and practitioners’ perceptions and experiences of OST. A total of 286 children, 7–16 years old, with DSM-IV diagnoses of specific phobia will be recruited via gatekeepers in the NHS, schools and voluntary youth services, and via public adverts.Ethics and disseminationThe trial received ethical approval from North East and York Research Ethics Committee (Reference: 17/NE/0012). Dissemination plans include publications in peer-reviewed journals, presentations in relevant research conferences, local research symposia and seminars for children and their families, and for professionals and service managers.Trial registration numberISRCTN19883421;Pre-results.

Download Full-text

One-day cognitive–behavioural therapy self-confidence workshops for people with depression: randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.112.121855 ◽

2014 ◽

Vol 204 (3) ◽

pp. 222-233 ◽

Cited By ~ 18

Author(s):

Linda Horrell ◽

Kimberley A. Goldsmith ◽

André T. Tylee ◽

Ulrike H. Schmidt ◽

Caroline L. Murphy ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Cognitive Behavioural Therapy ◽

Controlled Trial ◽

Self Esteem ◽

Behavioural Therapy ◽

Self Confidence ◽

Cognitive Behavioural ◽

Randomised Controlled

BackgroundDespite its high prevalence, help-seeking for depression is low.AimsTo assess the effectiveness and cost-effectiveness of 1-day cognitive–behavioural therapy (CBT) self-confidence workshops in reducing depression. Anxiety, self-esteem, prognostic indicators as well as access were also assessed.MethodAn open randomised controlled trial (RCT) waiting list control design with 12-week follow-up was used (trial registration: ISRCTN26634837). A total of 459 adult participants with depression (Beck Depression Inventory (BDI) scores of 14) self-referred and 382 participants (83%) were followed up.ResultsAt follow-up, experimental and control participants differed significantly on the BDI, with an effect size of 0.55. Anxiety and self-esteem also differed. Of those who participated, 25% were GP non-consulters and 32% were from Black and minority ethnic groups. Women benefited more than men on depression scores. The intervention has a 90% chance of being considered cost-effective if a depression-free day is valued at £14.ConclusionsSelf-confidence workshops appear promising in terms of clinical effectiveness, cost-effectiveness and access by difficult-to-engage groups.

Download Full-text

Cost-effectiveness of therapist-delivered online cognitive–behavioural therapy for depression: randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.109.073080 ◽

2010 ◽

Vol 197 (4) ◽

pp. 297-304 ◽

Cited By ~ 61

Author(s):

Sandra Hollinghurst ◽

Tim J. Peters ◽

Surinder Kaur ◽

Nicola Wiles ◽

Glyn Lewisand ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Usual Care ◽

Cognitive Behavioural Therapy ◽

Controlled Trial ◽

Behavioural Therapy ◽

Qaly Gain ◽

Cognitive Behavioural ◽

Life Years ◽

Randomised Controlled

BackgroundTherapist-delivered online cognitive–behavioural therapy (CBT) has been found to be effective for depression in primary care.AimsTo determine the cost-effectiveness of online CBT compared with usual care.MethodEconomic evaluation at 8 months alongside a randomised controlled trial. Cost to the National Health Service (NHS), personal costs, and the value of lost productivity, each compared with outcomes based on the Beck Depression Inventory and quality-adjusted life-years (QALYs). Incremental analysis indicated the NHS cost per QALY gain.ResultsOnline CBT was more expensive than usual care, although the outcomes for the CBT group were better. Cost per QALY gain based on complete case data was £17 173, and £10 083 when missing data were imputed.ConclusionsOnline CBT delivered by a therapist in real time is likely to be cost-effective compared with usual care if society is willing to pay at least £20 000 per QALY; it could be a useful alternative to face-to-face CBT.

Download Full-text

Guided self-help for depression in autistic adults: the ADEPT feasibility RCT

Health Technology Assessment ◽

10.3310/hta23680 ◽

2019 ◽

Vol 23 (68) ◽

pp. 1-94 ◽

Cited By ~ 1

Author(s):

Ailsa Russell ◽

Daisy Gaunt ◽

Kate Cooper ◽

Jeremy Horwood ◽

Stephen Barton ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Cognitive Behavioural Therapy ◽

Controlled Trial ◽

Behavioural Therapy ◽

Full Scale ◽

Treatment As Usual ◽

Low Intensity ◽

Self Help ◽

Cognitive Behavioural ◽

Randomised Controlled

Background Co-occurring depression frequently occurs in autism. Evidence-based psychological interventions have been successfully adapted to treat co-occurring anxiety, but there is little evidence about the usefulness of adapted cognitive–behavioural therapy for depression. To the authors’ knowledge, to date there have been no randomised trials investigating the usefulness of low-intensity cognitive–behavioural therapy for depression in autism. Objectives The objectives of the study were to (1) develop a low-intensity psychological intervention for depression adapted for autism, (2) assess the feasibility and patient and therapist acceptability of the intervention, (3) estimate the rates of recruitment and retention for a full-scale randomised controlled trial and (4) identify an appropriate measure of depression to be used in a full-scale randomised controlled trial. Design The study comprised a randomised controlled trial (n = 70) with a nested qualitative evaluation (n = 21). Seventy eligible and consenting participants were randomly allocated to guided self-help or to treatment as usual. Setting Adult autism services in two NHS regions. Participants Adults with a diagnosis of autism spectrum disorder with depression, that is, a Patient Health Questionnaire-9 items score of ≥ 10. People who had attended more than six sessions of cognitive–behavioural therapy in the previous 6 months were excluded. Interventions The low-intensity intervention (guided self-help) comprised materials for nine individual sessions, based on behavioural activation adapted for autism, facilitated by therapist guides (coaches) who were graduate-level psychologists who attended training and regular supervision. Treatment as usual was standard NHS care for depression. Main outcome measures Outcomes were measured 10, 16 and 24 weeks post randomisation using self-report and interview measures of depression, anxiety, obsessive–compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire. As this was a feasibility study also designed to identify the most appropriate measure of depression, it was not possible to specify the primary outcome measure or outcome point a priori. Results The aims of the study were met in full. The guided self-help intervention was feasible and well received by participants and coaches. The majority of allocated participants attended the intervention in full. The most practical outcome point was determined to be 16 weeks. There were differential rates of attrition across the treatment groups: 86% of the guided self-help group remained in the study at 24 weeks, compared with 54% of treatment as usual group. The qualitative study suggested that guided self-help had enhanced credibility with participants at the point of randomisation. Inter-rater reliability of the interview measure of depression was less than adequate, limiting the conclusions that can be drawn from the prespecified sensitivity to change analyses. Conclusions The intervention was feasible and well received. Although this feasibility study was not a fully powered trial, it provided some evidence that the guided self-help intervention was effective in reducing depressive symptoms. A full-scale clinical effectiveness and cost-effectiveness trial of the intervention is warranted. Future work Improvements to the intervention materials as a result of qualitative interviews. Stakeholder consultation to consider future trial design, consider strategies to improve retention in a treatment as usual arm and select a self-report measure of depression to serve as the primary outcome measure. Trial registration Current Controlled Trials ISRCTN54650760. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 68. See the NIHR Journals Library website for further project information. This study was also supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol.

Download Full-text

Increasing access to cognitive–behavioural therapy for patients with psychosis by evaluating the feasibility of a randomised controlled trial of brief, targeted cognitive–behavioural therapy for distressing voices delivered by assistant psychologists: the GiVE2 trial

BJPsych Open ◽

10.1192/bjo.2021.983 ◽

2021 ◽

Vol 7 (5) ◽

Author(s):

Mark Hayward ◽

Katherine Berry ◽

Stephen Bremner ◽

Anna-Marie Jones ◽

Sam Robertson ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Cognitive Behavioural Therapy ◽

Controlled Trial ◽

Behavioural Therapy ◽

Post Treatment ◽

Treatment As Usual ◽

Cognitive Behavioural ◽

Supportive Counselling ◽

Randomised Controlled

Background Cognitive–behavioural therapy (CBT) is recommended for all patients with psychosis, but is offered to only a minority. This is attributable, in part, to the resource-intensive nature of CBT for psychosis. Responses have included the development of CBT for psychosis in brief and targeted formats, and its delivery by briefly trained therapists. This study explored a combination of these responses by investigating a brief, CBT-informed intervention targeted at distressing voices (the GiVE intervention) administered by a briefly trained workforce of assistant psychologists. Aims To explore the feasibility of conducting a randomised controlled trial to evaluate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists to patients with psychosis. Method This was a three-arm, feasibility, randomised controlled trial comparing the GiVE intervention, a supportive counselling intervention and treatment as usual, recruiting across two sites, with 1:1:1 allocation and blind post-treatment and follow-up assessments. Results Feasibility outcomes were favourable with regard to the recruitment and retention of participants and the adherence of assistant psychologists to therapy and supervision protocols. For the candidate primary outcomes, estimated effects were in favour of GiVE compared with supportive counselling and treatment as usual at post-treatment. At follow-up, estimated effects were in favour of supportive counselling compared with GiVE and treatment as usual, and GiVE compared with treatment as usual. Conclusions A definitive trial of the GiVE intervention, delivered by assistant psychologists, is feasible. Adaptations to the GiVE intervention and the design of any future trials may be necessary.

Download Full-text

Effectiveness of cognitive–behavioural therapy for depression in advanced cancer: CanTalk randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.2019.207 ◽

2019 ◽

Vol 216 (4) ◽

pp. 213-221

Author(s):

Marc Serfaty ◽

Michael King ◽

Irwin Nazareth ◽

Stirling Moorey ◽

Trefor Aspden ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Cognitive Behavioural Therapy ◽

Advanced Cancer ◽

Group Performance ◽

Controlled Trial ◽

Behavioural Therapy ◽

Secondary Outcome ◽

Cancer Trial ◽

Cognitive Behavioural ◽

Randomised Controlled

BackgroundDepression is one of the most common mental disorders in people with advanced cancer. Although cognitive–behavioural therapy (CBT) has been shown to be effective for depression in people with cancer, it is unclear whether this is the case for people with advanced cancer and depression.AimsWe sought to determine whether CBT is more clinically effective than treatment as usual (TAU) for treating depression in people with advanced cancer (trial registration number ISRCTN07622709).MethodA multi-centre, parallel-group single-blind randomised controlled trial comparing TAU with CBT (plus TAU). Participants (n = 230) with advanced cancer and depression were randomly allocated to (a) up to 12 sessions of individual CBT or (b) TAU. The primary outcome measure was the Beck Depression Inventory-II (BDI-II). Secondary outcome measures included the Patient Health Questionnaire-9, the Eastern Cooperative Oncology Group Performance Status, and Satisfaction with Care.ResultsMultilevel modelling, including complier-average intention-to-treat analysis, found no benefit of CBT. CBT delivery was proficient, but there was no treatment effect (−0.84, 95% CI −2.76 to 1.08) or effects for secondary measures. Exploratory subgroup analysis suggested an effect of CBT on the BDI-II in those widowed, divorced or separated (−7.21, 95% CI −11.15 to −3.28).ConclusionsUK National Institute for Health and Care Excellence (NICE) guidelines recommend CBT for treating depression. Delivery of CBT through the Improving Access to Psychological Therapies (IAPT) programme has been advocated for long-term conditions such as cancer. Although it is feasible to deliver CBT through IAPT proficiently to people with advanced cancer, this is not clinically effective. CBT for people widowed, divorced or separated needs further exploration. Alternate models of CBT delivery may yield different results.

Download Full-text