scholarly journals 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 ◽  
2021 ◽  
Vol 7 (5) ◽  
Author(s):  
Mark Hayward ◽  
Katherine Berry ◽  
Stephen Bremner ◽  
Anna-Marie Jones ◽  
Sam Robertson ◽  
...  

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.

2015 ◽  
Vol 206 (6) ◽  
pp. 509-516 ◽  
Author(s):  
Aimee Spector ◽  
Georgina Charlesworth ◽  
Michael King ◽  
Miles Lattimer ◽  
Susan Sadek ◽  
...  

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.


BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e017177 ◽  
Author(s):  
Dan Denis ◽  
Thalia C Eley ◽  
Fruhling Rijsdijk ◽  
Helena M S Zavos ◽  
Robert Keers ◽  
...  

IntroductionCognitive–behavioural therapy for insomnia (CBT-I) leads to insomnia symptom improvements in a substantial proportion of patients. However, not everyone responds well to this treatment, and it is unclear what determines individual differences in response. The broader aim of this work is to examine to what extent response to CBT-I is due to genetic and environmental factors. The purpose of this pilot study is to examine feasibility of a design to test hypotheses focusing on an unselected sample, that is, without selection on insomnia complaints, in order to plan a larger behavioural genetics study where most participants will likely not have an insomnia disorder.Methods and analysisA two parallel-group randomised controlled trial is being conducted across three London universities. Female students (minimum age 18 years) enrolled on a psychology programme at one of the three sites were invited to participate. The target number of participants to be recruited is 240. Following baseline assessments, participants were randomly allocated to either the treatment group, where they received weekly sessions of digital CBT-I for 6 weeks, or the control group, where they completed an online puzzle each week for 6 weeks. Follow-up assessments have taken place mid-intervention (3 weeks) and end of intervention (6 weeks). A 6-month follow-up assessment will also occur. Primary outcomes will be assessed using descriptive statistics and effect size estimates for intervention effects. Secondary outcomes will be analysed using multivariate generalised estimating equation models.Ethics and disseminationThe study received ethical approval from the Research Ethics and Integrity subcommittee, Goldsmiths, University of London (application reference: EA 1305). DNA sample collection for the BioResource received ethical approval from the NRES Committee South Central—Oxford (reference number: 15/SC/0388). The results of this work shall be published in peer-reviewed journals.Trial registration numberNCT03062891; Results.


2017 ◽  
Vol 210 (3) ◽  
pp. 223-229 ◽  
Author(s):  
Zhi-Hua Guo ◽  
Zhan-Jiang Li ◽  
Yun Ma ◽  
Jing Sun ◽  
Jun-Hua Guo ◽  
...  

BackgroundBrief cognitive–behavioural therapy (CBT) is an emerging treatment for schizophrenia in community settings; however, further trials are needed, especially in non-Western countries.AimsTo test the effects of brief CBT for Chinese patients with schizophrenia in the community (trial registration: ChiCTR-TRC-13003709).MethodA total of 220 patients with schizophrenia from four districts of Beijing were randomly assigned to either brief CBT plus treatment as usual (TAU) or TAU alone. Patients were assessed at baseline, post-treatment and at 6- and 12-month follow-ups by raters masked to group allocation.ResultsAt the post-treatment assessment and the 12-month follow-up, patients who received brief CBT showed greater improvement in overall symptoms, general psychopathology, insight and social functioning. In total, 37.3% of those in the brief CBT plus TAU group experienced a clinically significant response, compared with only 19.1% of those in the TAU alone group (P= 0.003).ConclusionsBrief CBT has a positive effect on Chinese patients with schizophrenia in the community.


2014 ◽  
Vol 204 (3) ◽  
pp. 222-233 ◽  
Author(s):  
Linda Horrell ◽  
Kimberley A. Goldsmith ◽  
André T. Tylee ◽  
Ulrike H. Schmidt ◽  
Caroline L. Murphy ◽  
...  

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.


2019 ◽  
Vol 23 (68) ◽  
pp. 1-94 ◽  
Author(s):  
Ailsa Russell ◽  
Daisy Gaunt ◽  
Kate Cooper ◽  
Jeremy Horwood ◽  
Stephen Barton ◽  
...  

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.


1998 ◽  
Vol 173 (1) ◽  
pp. 61-68 ◽  
Author(s):  
Elizabeth Kuipers ◽  
David Fowler ◽  
Phiuppa Garety ◽  
Daniel Chisholm ◽  
Daniel Freeman ◽  
...  

BackgroundA randomised controlled trial of cognitive — behavioural therapy (CBT) for people with medication-resistant psychosis showed improvements in overall symptomatology after nine months of treatment; good outcome was strongly predicted by a measure of cognitive flexibility concerning delusions. The present paper presents a follow-up evaluation 18 months after baseline.MethodForty-seven (78% of original n=60) participants were available for follow-up at 18 months, and were reassessed on all the original outcome measures (see Part I). An economic evaluation was also completed.ResultsThose in the CBT treatment group showed a significant and continuing improvement in Brief Psychiatric Rating Scale scores, whereas the control group did not change from baseline. Delusional distress and the frequency of hallucinations were also significantly reduced in the CBT group. The costs of CB Tappear to have been offset by reductions in service utilisation and associated costs during follow-up.ConclusionsImprovement in overall symptoms was maintained in the CBT group 18 months after baseline and nine months after intensive therapy was completed. CBT may be a specific and cost-effective intervention in medication-resistant psychosis.


Gut ◽  
2019 ◽  
pp. gutjnl-2018-317805 ◽  
Author(s):  
Hazel Anne Everitt ◽  
Sabine Landau ◽  
Gilly O’Reilly ◽  
Alice Sibelli ◽  
Stephanie Hughes ◽  
...  

ObjectiveTo evaluate the clinical effectiveness of two modes of cognitive–behavioural therapy (CBT) for IBS compared with treatment as usual (TAU) in refractory IBS.DesignA three-arm randomised controlled trial assessing telephone-delivered CBT (TCBT), web-based CBT (WCBT) with minimal therapist support, and TAU. Blinding participants and therapists was not possible. Chief investigator, assessors and statisticians were blinded. Participants were adults with refractory IBS (clinically significant symptoms for ≥12 months despite first-line therapies), recruited by letter and opportunistically from 74 general practices and three gastroenterology centres in London and South of England between May 2014 to March 2016. Co-primary outcomes were IBS Symptom Severity Score (IBS-SSS) and Work and Social Adjustment Scale (WSAS) at 12 months.Results558/1452 (38.4%) patients screened for eligibility were randomised: 76% female: 91% white: mean age 43 years. (391/558) 70.1% completed 12 months of follow-up. Primary outcomes: Compared with TAU (IBS-SSS 205.6 at 12 months), IBS-SSS was 61.6 (95% CI 33.8 to 89.5) points lower (p<0.001) in TCBT and 35.2 (95% CI 12.6 to 57.8) points lower (p=0.002) in WCBT at 12 months. Compared with TAU (WSAS score 10.8 at 12 months) WSAS was 3.5 (95% CI 1.9 to 5.1) points lower (p<0.001) in TCBT and 3.0 (95% CI 1.3 to 4.6) points lower (p=0.001) in WCBT. All secondary outcomes showed significantly greater improvement (p≤0.002) in CBT arms compared with TAU. There were no serious adverse reactions to treatment.ConclusionBoth CBT interventions were superior to TAU up to 12 months of follow-up.Trial registration numberISRCTN44427879.


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