Cognitive behavioural therapy plus standard care versus standard care for people with schizophrenia.
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ABSTRACT:
SUBMITTER: Jones C
PROVIDER: S-EPMC6517137 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC6516879 | biostudies-literature
Project description:To compare the effectiveness and cost of stepped care trauma-focused cognitive behavioral therapy (SC-TF-CBT), a new service delivery method designed to address treatment barriers, to standard TF-CBT among young children who were experiencing posttraumatic stress symptoms (PTSS).A total of 53 children (ages 3-7 years) who were experiencing PTSS were randomly assigned (2:1) to receive SC-TF-CBT or TF-CBT. Assessments by a blinded evaluator occurred at screening/baseline, after Step One for SC-TF-CBT, posttreatment, and 3-month follow-up.ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT01603563.There were comparable improvements over time in PTSS and secondary outcomes in both conditions. Noninferiority of SC-TF-CBT compared to TF-CBT was supported for the primary outcome of PTSS, and the secondary outcomes of severity and internalizing symptoms, but not for externalizing symptoms. There were no statistical differences in comparisons of changes over time from pre- to posttreatment and pre- to 3-month follow-up for posttraumatic stress disorder diagnostic status, treatment response, or remission. Parent satisfaction was high for both conditions. Costs were 51.3% lower for children in SC-TF-CBT compared to TF-CBT.Although future research is needed, preliminary evidence suggests that SC-TF-CBT is comparable to TF-CBT, and delivery costs are significantly less than standard care. SC-TF-CBT may be a viable service delivery system to address treatment barriers.
| S-EPMC4824681 | biostudies-literature
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.
| S-EPMC6506966 | biostudies-literature
Project description:Background:Cognitive-behavioural therapy (CBT) is the treatment of choice for generalised anxiety disorder (GAD), yielding significant improvements in approximately 50% of patients. There is significant room for improvement in the outcomes of treatment, especially in recovery. Aims:We aimed to compare metacognitive therapy (MCT) with the gold standard treatment, CBT, in patients with GAD (clinicaltrials.gov identifier: NCT00426426). Method:A total of 246 patients with long-term GAD were assessed and 81 were randomised into three conditions: CBT (n = 28), MCT (n = 32) and a wait-list control (n = 21). Assessments were made at pre-treatment, post-treatment and at 2 year follow-up. Results:Both CBT and MCT were effective treatments, but MCT was more effective (mean difference 9.762, 95% CI 2.679-16.845, P = 0.004) and led to significantly higher recovery rates (65% v. 38%). These differences were maintained at 2 year follow-up. Conclusions:MCT seems to produce recovery rates that exceed those of CBT. These results demonstrate that the effects of treatment cannot be attributed to non-specific therapy factors. Declaration of interest:A.W. wrote the treatment protocol in MCT and several books on CBT and MCT, and receives royalties from these. T.D.B. wrote the protocol in CBT and has published several articles and chapters on CBT and receives royalties from these. All other authors declare no competing interests.
| S-EPMC6171331 | biostudies-literature
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.
| S-EPMC6048761 | biostudies-literature
Project description:Tuberculosis is a major public health concern resulting in high rates of morbidity and mortality worldwide, particularly in low- and middle-income countries. Tuberculosis requires a long and intensive course of treatment. Thus, various approaches, including patient empowerment, education and counselling sessions, and involvement of family members and community workers, have been suggested for improving treatment adherence and outcome. The current randomized controlled trial aims to evaluate the effectiveness over usual care of an innovative multicomponent people-centered tuberculosis-care strategy in Armenia.Innovative Approach to Tuberculosis care in Armenia is an open-label, stratified cluster randomized controlled trial with two parallel arms. Tuberculosis outpatient centers are the clusters assigned to intervention and control arms. Drug-sensitive tuberculosis patients in the continuation phase of treatment in the intervention arm and their family members participate in a short educational and counselling session to raise their knowledge, decrease tuberculosis-related stigma, and enhance treatment adherence. Patients receive the required medications for one week during the weekly visits to the tuberculosis outpatient centers. Additionally, patients receive daily Short Message Service (SMS) reminders to take their medications and daily phone calls to assure adherence and monitoring of treatment potential side effects. Control-arm patients follow the World Health Organization--recommended directly observed treatment strategy, including daily visits to tuberculosis outpatient centers for drug-intake. The primary outcome is physician-reported treatment outcome. Patients' knowledge, depression, quality of life, within-family tuberculosis-related stigma, family social support, and self-reported adherence to tuberculosis treatment are secondary outcomes.Improved adherence and tuberculosis treatment outcomes can strengthen tuberculosis control and thereby forestall tuberculosis and multidrug resistant tuberculosis epidemics. Positive findings on effectiveness of this innovative tuberculosis treatment people-centered approach will support its adoption in countries with similar healthcare and economic profiles.ClinicalTrials.gov registration number: NCT02082340. Date of registration: 4 March 2014.
| S-EPMC4479352 | biostudies-literature
Project description:Current practice guidelines for schizophrenia care recommend that antipsychotic medication is essential for patients' long-term maintenance treatment but their non-adherence to this medication is still a main obstacle to relapse prevention. This study evaluated the effects of a motivational-interviewing-based adherence therapy for people with schizophrenia spectrum disorders.This randomised controlled trial was conducted with 134 outpatients with schizophrenia spectrum disorders; 67 of them received a six-session adherence therapy (in addition to usual care) and 67 received usual psychiatric care alone. Participants' outcome measures included symptom severity, medication adherence, hospitalisation rates, insight into illness/treatment, and functioning.The adherence therapy group reported significantly greater improvements in symptom severity (p < 0.003), insight into illness/treatment (p < 0.001), functioning (p < 0.005), duration of re-hospitalisations (p < 0.005), and medication adherence (p < 0.005) over 18 months follow-up, when compared with usual care alone.Motivational-interviewing-based adherence therapy can be an effective approach to treatment for people with early stage of schizophrenia who poorly adhere to medication regimen.ClinicalTrials.gov NCT01780116, registration date January 29, 2013.
| S-EPMC4766670 | biostudies-literature
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.
| S-EPMC4163968 | biostudies-literature
Project description:Schizophrenia leads to significant personal costs matched by high economic costs. Cognitive function is a strong predictor of disabilities in schizophrenia, which underpin these costs. This study of cognitive remediation therapy (CRT), which has been shown to improve cognition and reduce disability in schizophrenia, aims to investigate associations between improvements in cognition and cost changes.Eighty-five participants with schizophrenia were randomized to receive CRT or treatment as usual and were assessed at baseline, posttherapy, and 6 month follow-up. Four structural equation models investigated associations between changes in cognitive function and costs of care.All 4 models provided a good fit. Improvement in 3 individual cognitive variables did not predict total cost changes (model 1). But improvement in a single latent cognition factor was associated with a reduction in depression, which in turn was associated with reduced subsequent total costs (model 2). No significant associations with constituent daycare and special accommodation cost changes were apparent with 3 individual cognitive change variables (model 3). But improvement in a single latent cognitive change variable was associated with subsequent reductions in both daycare and special accommodation costs (model 4).This study exemplifies a method of using cost changes to investigate the effects and mechanisms of CRT and suggests that executive function change may be an important target if we are to reduce disability and resultant health and social care costs.
| S-EPMC4193717 | biostudies-literature
Project description:This study compared the best available treatment for bulimia nervosa, cognitive-behavioural therapy (CBT) augmented by fluoxetine if indicated, with a stepped-care treatment approach in order to enhance treatment effectiveness.To establish the relative effectiveness of these two approaches.This was a randomised trial conducted at four clinical centres (Clinicaltrials.gov registration number: NCT00733525). A total of 293 participants with bulimia nervosa were randomised to one of two treatment conditions: manual-based CBT delivered in an individual therapy format involving 20 sessions over 18 weeks and participants who were predicted to be non-responders after 6 sessions of CBT had fluoxetine added to treatment; or a stepped-care approach that began with supervised self-help, with the addition of fluoxetine in participants who were predicted to be non-responders after six sessions, followed by CBT for those who failed to achieve abstinence with self-help and medication management.Both in the intent-to-treat and completer samples, there were no differences between the two treatment conditions in inducing recovery (no binge eating or purging behaviours for 28 days) or remission (no longer meeting DSM-IV criteria). At the end of 1-year follow-up, the stepped-care condition was significantly superior to CBT.Therapist-assisted self-help was an effective first-level treatment in the stepped-care sequence, and the full sequence was more effective than CBT suggesting that treatment is enhanced with a more individualised approach.
| S-EPMC3093678 | biostudies-literature