Project description:BackgroundCognitive behavioural therapy (CBT) is now a recommended treatment for people with schizophrenia. This approach helps to link the person's distress and problem behaviours to underlying patterns of thinking.ObjectivesTo review the effects of CBT for people with schizophrenia when compared with other psychological therapies.Search methodsWe searched the Cochrane Schizophrenia Group Trials Register (March 2010) which is based on regular searches of CINAHL, EMBASE, MEDLINE and PsycINFO. We inspected all references of the selected articles for further relevant trials, and, where appropriate, contacted authors.Selection criteriaAll relevant randomised controlled trials (RCTs) of CBT for people with schizophrenia-like illnesses.Data collection and analysisStudies were reliably selected and assessed for methodological quality. Two review authors, working independently, extracted data. We analysed dichotomous data on an intention-to-treat basis and continuous data with 65% completion rate are presented. Where possible, for dichotomous outcomes, we estimated a risk ratio (RR) with the 95% confidence interval (CI) along with the number needed to treat/harm.Main resultsThirty papers described 20 trials. Trials were often small and of limited quality. When CBT was compared with other psychosocial therapies, no difference was found for outcomes relevant to adverse effect/events (2 RCTs, n = 202, RR death 0.57 CI 0.12 to 2.60). Relapse was not reduced over any time period (5 RCTs, n = 183, RR long-term 0.91 CI 0.63 to 1.32) nor was rehospitalisation (5 RCTs, n = 294, RR in longer term 0.86 CI 0.62 to 1.21). Various global mental state measures failed to show difference (4 RCTs, n = 244, RR no important change in mental state 0.84 CI 0.64 to 1.09). More specific measures of mental state failed to show differential effects on positive or negative symptoms of schizophrenia but there may be some longer term effect for affective symptoms (2 RCTs, n = 105, mean difference (MD) Beck Depression Inventory (BDI) -6.21 CI -10.81 to -1.61). Few trials report on social functioning or quality of life. Findings do not convincingly favour either of the interventions (2 RCTs, n = 103, MD Social Functioning Scale (SFS) 1.32 CI -4.90 to 7.54; n = 37, MD EuroQOL -1.86 CI -19.20 to 15.48). For the outcome of leaving the study early, we found no significant advantage when CBT was compared with either non-active control therapies (4 RCTs, n = 433, RR 0.88 CI 0.63 to 1.23) or active therapies (6 RCTs, n = 339, RR 0.75 CI 0.40 to 1.43)Authors' conclusionsTrial-based evidence suggests no clear and convincing advantage for cognitive behavioural therapy over other - and sometime much less sophisticated - therapies for people with schizophrenia.

Project description:PurposeChemotherapy-induced peripheral neuropathy (CIPN) is a dose limiting toxicity posing a major clinical challenge for managing patients receiving specific chemotherapy regimens (e.g., Taxanes). There is a growing body of literature suggesting acupuncture can improve CIPN symptoms. The purpose of the ACUFOCIN trial was to collect preliminary data on the safety, feasibility, acceptability and initial effectiveness of acupuncture as a treatment for CIPN, comparing use of acupuncture plus standard care (Acupuncture) against standard care alone (Control).MethodAt a tertiary cancer centre, a pragmatic, randomised, parallel group design study was used to investigate the effectiveness of a 10-week course of acupuncture. Participants experiencing CIPN of ≥ Grade II, recording a 'Most Troublesome' CIPN symptom score of ≥3 using the "Measure Yourself Medical Outcome Profile" (MYMOP 2), were randomised to 'Acupuncture' or 'Control' arms. Clinicians were blinded to allocated groups, however as it was not possible to blind participants, it cannot be guaranteed they did not disclose study allocation within their clinic assessments. The primary outcome measure was the number of patients reporting a ≥ 2-point improvement (success) in their MYMOP2 score at week 10. 100 participants (120 to allow for attrition) were required for a hypothesised improvement in success proportions from 30% to 55% using a primary analysis model with logistic regression adjusted for stratification factors and baseline MYMOP2 scores. Feasibility and acceptability of study design was addressed through percentage return of primary outcome, retention rate and a nested qualitative study.ResultsPrimary MYMOP2 outcome data at week 10 was available for 108/120 randomised participants; this is greater than the 100 participants required to adequately power the study. There were 36/53 (68%) successes in 'Acupuncture' compared to 18/55 (33%) in 'Control'. Beneficial effects were seen in the secondary outcome data, including clinicians' grading of neuropathy, EORTC, QLQ-CIPN20, QLQ-C30 summary scores and patient reported pain scores. There were no serious adverse events reported within the study and only 16 acupuncture associated events, none of which required intervention.ConclusionA 10-week course of acupuncture resulted in measurable improvement in participants symptoms of CIPN. The results warrant further investigation.

Project description:BackgroundChronic malnutrition is a condition associated with negative impacts on physical and cognitive development. It is multi-causal and can start very early in life, already in utero, thus it is especially challenging to find appropriate interventions to tackle it. The government of Angola is implementing a standard of care program with potential to prevent it, and the provision of cash transfers and the supplementation with small quantity lipid-based nutrients (SQ-LNS) are also promising interventions. We aimed to evaluate the impact of the standard of care program alone and of the standard of care plus a cash transfer intervention in the lineal growth of children less than 2 years old and compare it to the effectiveness of a nutrition supplementation plus standard of care program in Southern Angola.Methods/designThe three-arm parallel cluster randomised controlled trial is set in four communes of Huila and Cunene provinces. Clusters are villages or neighbourhoods with a population around 1075 people. A total of twelve clusters were selected per arm and forty pregnant women are expected to be recruited in each cluster. Pregnant women receive the standard of care alone, or the standard of care plus unconditional cash transfer or plus nutritional supplementation during the first 1000 days, from pregnancy to the child reaching 24 months. The primary outcome is the prevalence of stunting measured as height-for-age Z-score (HAZ) < -2 in children below 2 years. Impact will be assessed at 3, 6, 12, 18 and 24 months of children's age. Secondary outcomes include mortality, morbidity, caring, hygiene and nutrition behaviours and practices, and women and children's dietary diversity. Quantitative data are also collected on women's empowerment, household food security, expenditure and relevant clinical and social events at baseline, endline and intermediate time points.DiscussionThe results will provide valuable information on the impact of the standard of care intervention alone as well as combined with an unconditional cash transfer intervention compared to a nutrition supplementation plus standard of care intervention, carried out during the first 1000 days, in the children´s growth up to 2 years and related outcomes in Southern Angola.Trial registrationClinical Trials NCT05571280. Registered 7 October 2022.

Project description:BackgroundLittle evidence is available for head-to-head comparisons of psychosocial interventions and pharmacological interventions in psychosis. We aimed to establish whether a randomised controlled trial of cognitive behavioural therapy (CBT) versus antipsychotic drugs versus a combination of both would be feasible in people with psychosis.MethodsWe did a single-site, single-blind pilot randomised controlled trial in people with psychosis who used services in National Health Service trusts across Greater Manchester, UK. Eligible participants were aged 16 years or older; met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service; were in contact with mental health services, under the care of a consultant psychiatrist; scored at least 4 on delusions or hallucinations items, or at least 5 on suspiciousness, persecution, or grandiosity items on the Positive and Negative Syndrome Scale (PANSS); had capacity to consent; and were help-seeking. Participants were assigned (1:1:1) to antipsychotics, CBT, or antipsychotics plus CBT. Randomisation was done via a secure web-based randomisation system (Sealed Envelope), with randomised permuted blocks of 4 and 6, stratified by gender and first episode status. CBT incorporated up to 26 sessions over 6 months plus up to four booster sessions. Choice and dose of antipsychotic were at the discretion of the treating consultant. Participants were followed up for 1 year. The primary outcome was feasibility (ie, data about recruitment, retention, and acceptability), and the primary efficacy outcome was the PANSS total score (assessed at baseline, 6, 12, 24, and 52 weeks). Non-neurological side-effects were assessed systemically with the Antipsychotic Non-neurological Side Effects Rating Scale. Primary analyses were done by intention to treat; safety analyses were done on an as-treated basis. The study was prospectively registered with ISRCTN, number ISRCTN06022197.FindingsOf 138 patients referred to the study, 75 were recruited and randomly assigned-26 to CBT, 24 to antipsychotics, and 25 to antipsychotics plus CBT. Attrition was low, and retention high, with only four withdrawals across all groups. 40 (78%) of 51 participants allocated to CBT attended six or more sessions. Of the 49 participants randomised to antipsychotics, 11 (22%) were not prescribed a regular antipsychotic. Median duration of total antipsychotic treatment was 44·5 weeks (IQR 26-51). PANSS total score was significantly reduced in the combined intervention group compared with the CBT group (-5·65 [95% CI -10·37 to -0·93]; p=0·019). PANSS total scores did not differ significantly between the combined group and the antipsychotics group (-4·52 [95% CI -9·30 to 0·26]; p=0·064) or between the antipsychotics and CBT groups (-1·13 [95% CI -5·81 to 3·55]; p=0·637). Significantly fewer side-effects, as measured with the Antipsychotic Non-neurological Side Effects Rating Scale, were noted in the CBT group than in the antipsychotics (3·22 [95% CI 0·58 to 5·87]; p=0·017) or antipsychotics plus CBT (3·99 [95% CI 1·36 to 6·64]; p=0·003) groups. Only one serious adverse event was thought to be related to the trial (an overdose of three paracetamol tablets in the CBT group).InterpretationA head-to-head clinical trial of CBT versus antipsychotics versus the combination of the two is feasible and safe in people with first-episode psychosis.FundingNational Institute for Health Research.

Project description:BackgroundInsomnia is a prevalent sleep disorder associated with significant economic and personal burdens. Cognitive behavioural therapy for insomnia (CBTI) is considered the gold standard intervention for insomnia and its efficacy has been well demonstrated. However, the core treatment strategies of CBTI require significant behavioural change, which many individuals find challenging. As a result, although CBTI is efficacious, its effectiveness is reduced by modest levels of adherence in typical clinical settings. This is problematic as adherence is essential to attain desired treatment outcomes. Sleep is often a dyadic process, with approximately 60% of Australian adults sharing a bed. Hence, the present study aims to determine whether incorporating bed partners into treatment for insomnia increases treatment adherence and completion. The impact of adherence on symptoms of insomnia will also be examined.MethodsThis study is a mixed-effects randomised effectiveness trial of partner-assisted CBTI (PA-CBTI). It is an "effectiveness" (as opposed to "efficacy") trial, due to the focus on "real world" clinic-based clients and adherence/attrition as outcomes. Participants will include 120 clients with insomnia who are randomly assigned, in equal numbers, to PA-CBTI, traditional individual CBTI (i-CBTI), or partner-assisted sleep management therapy (PA-SMT; which serves as the control group). All interventions consist of seven weekly 1-h sessions. Treatment outcome is evaluated using clinician-rated treatment adherence, and diary-based adherence to stimulus control and sleep restriction. Clients and partners complete major assessments at pre- and post-treatment, and at 6-month follow-up. Secondary outcome variables include actigraphy, self-report measures related to sleep, comorbid psychopathology, and relationship functioning.DiscussionThis is the first randomised clinical trial to examine the impact of incorporating the bed partner in the treatment of insomnia. Results will provide new information about the role partners play in clients' insomnia presentation and treatment response, and better define the role of adherence in CBTI. This trial has the potential to optimise treatment outcomes for insomnia by improving adherence and reducing attrition. Results could have far-reaching impacts. Improvements in insomnia have been linked to improvements in mental and physical health and, given the high financial costs of insomnia, this study could have a positive economic impact.Trial registrationACTRN, ACTRN12616000586415 . Registered on 5 May 2016.

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Cognitive behavioural therapy plus standard care versus standard care plus other psychosocial treatments for people with schizophrenia.

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