Dataset Information

Six-month outcomes of the CODES randomised controlled trial of cognitive behavioural therapy for dissociative seizures: A secondary analysis.

ABSTRACT:

Purpose

The CODES Trial for adults with dissociative seizures had a predesignated 12-month post-randomisation follow-up point for outcome evaluation. We undertook an exploratory, unplanned, secondary analysis to evaluate the effectiveness of cognitive behavioural therapy plus standardised medical care (CBT+SMC) compared to SMC alone at 6 months post-randomisation, i.e., closer to the end of treatment.

Methods

The analysis of 6-month data followed our previous method of using multiple imputation and an intention-to-treat approach to analyse variables 12 months post-randomisation.

Results

The original trial primary outcome of monthly seizure frequency showed greater benefit from CBT+SMC than SMC-alone at 6 months (at p < 0.05). Of 13 comparable previously-defined secondary outcomes, 12 showed a significant between group effect (p < 0.05) in favour of the CBT intervention at 6 months. The average effect size of the comparable previously-defined primary and secondary continuous outcomes was 0.33 at 6 months vs 0.26 at 12 months. The estimated Incidence Rate Ratio (IRR) quantifying monthly seizure reduction was IRR = 0.72 (95%CI from 0.55 to 0.93) at 6 months compared to IRR = 0.78 at 12 months.

Conclusion

DS-specific CBT (plus SMC) produced evidence of significant benefits at 6 months post- randomisation (around which time CBT was complete) compared to SMC alone; for the majority of these outcomes, better results following CBT (plus SMC) had previously been reported at 12 months. Our pattern of results suggests that short- and longer-term follow-ups are necessary to understand treatment effects in this disorder. Studies only providing short-term follow-up data should be interpreted with caution.

SUBMITTER: Goldstein LH

PROVIDER: S-EPMC8970049 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Publications

Six-month outcomes of the CODES randomised controlled trial of cognitive behavioural therapy for dissociative seizures: A secondary analysis.

Goldstein Laura H LH Robinson Emily J EJ Chalder Trudie T Reuber Markus M Medford Nick N Stone Jon J Carson Alan A Moore Michele M Landau Sabine S

Seizure 20220125

<h4>Purpose</h4>The CODES Trial for adults with dissociative seizures had a predesignated 12-month post-randomisation follow-up point for outcome evaluation. We undertook an exploratory, unplanned, secondary analysis to evaluate the effectiveness of cognitive behavioural therapy plus standardised medical care (CBT+SMC) compared to SMC alone at 6 months post-randomisation, i.e., closer to the end of treatment.<h4>Methods</h4>The analysis of 6-month data followed our previous method of using multi ...[more]

PMID: 35228117

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Project description:BackgroundThe evidence base for the effectiveness of psychological interventions for patients with dissociative non-epileptic seizures (DS) is currently extremely limited, although data from two small pilot randomised controlled trials (RCTs), including from our group, suggest that Cognitive Behavioural Therapy (CBT) may be effective in reducing DS occurrence and may improve aspects of psychological status and psychosocial functioning.Methods/designThe study is a multicentre, pragmatic parallel group RCT to evaluate the clinical and cost-effectiveness of specifically-tailored CBT plus standardised medical care (SMC) vs SMC alone in reducing DS frequency and improving psychological and health-related outcomes. In the initial screening phase, patients with DS will receive their diagnosis from a neurologist/epilepsy specialist. If patients are eligible and interested following the provision of study information and a booklet about DS, they will consent to provide demographic information and fortnightly data about their seizures, and agree to see a psychiatrist three months later. We aim to recruit ~500 patients to this screening stage. After a review three months later by a psychiatrist, those patients who have continued to have DS in the previous eight weeks and who meet further eligibility criteria will be told about the trial comparing CBT + SMC vs SMC alone. If they are interested in participating, they will be given a further booklet on DS and study information. A research worker will see them to obtain their informed consent to take part in the RCT. We aim to randomise 298 people (149 to each arm). In addition to a baseline assessment, data will be collected at 6 and 12 months post randomisation. Our primary outcome is monthly seizure frequency in the preceding month. Secondary outcomes include seizure severity, measures of seizure freedom and reduction, psychological distress and psychosocial functioning, quality of life, health service use, cost effectiveness and adverse events. We will include a nested qualitative study to evaluate participants' views of the intervention and factors that acted as facilitators and barriers to participation.DiscussionThis study will be the first adequately powered evaluation of CBT for this patient group and offers the potential to provide an evidence base for treating this patient group.Trial registrationCurrent Controlled Trials ISRCTN05681227 ClinicalTrials.gov NCT02325544.

Project description:ObjectivesLittle is known about the experiences of therapists delivering psychotherapy for patients with dissociative seizures (DS), a complex disorder associated with a range of comorbid psychosocial and mental health difficulties. This study set out to explore therapists' experiences of delivering DS-specific, manualized cognitive behavioral therapy (CBT) to adults with DS within the context of a randomized control trial.MethodsInterviews were conducted with 12 therapists involved in the COgnitive behavioral therapy vs standardized medical care for adults with Dissociative non-Epileptic Seizures (CODES) trial and were analyzed using thematic framework analysis (TFA).ResultsSix main themes emerged, namely 1) aspects of the intervention that were favored, while others were not always considered applicable; 2) multiple and complex difficulties faced by patients; 3) working effectively within the protocol; 4) limitations of the protocol; 5) significance of formulation; and 6) quality of standardized medical care (SMC) and difficulties of diagnosis delivery. These addressed valued aspects of the intervention, complexities of the patient group, and experiences working within a structured treatment protocol. Family involvement and psychoeducation were highlighted as important components; the applicability of graded exposure techniques, however, was restricted by patients' apparent emotional avoidance. The structure provided by the treatment protocol was valued, but flexibility was important to individualize treatment in complex cases. A comprehensive formulation was fundamental to this. The initial diagnostic explanation provided by neurologists and psychiatrists was generally considered beneficial, with patients often perceived to enter therapy with a better understanding of their condition.ConclusionsThis study demonstrated that the DS-specific CBT intervention met with general approval from therapists who also highlighted some practical challenges. Because of the nature of the condition, the need for experience of working with complex patients should be considered when applying the intervention to individual cases. Setting the CBT intervention in the context of a structured care pathway involving neurology and psychiatry may facilitate the therapeutic process.

Project description:ObjectivesThe current study examined predictors of outcomes of internet-based cognitive-behavioural therapy (ICBT) for individuals with tinnitus.DesignSecondary analysis of intervention studies.SettingInternet-based guided tinnitus intervention provided in the UK.Participants228 individuals who underwent ICBT.InterventionsICBT.Primary and secondary outcome measuresThe key predictor variables included demographic, tinnitus, hearing-related and treatment-related variables as well as clinical factors (eg, anxiety, depression, insomnia), which can have an impact on the treatment outcome. A 13-point reduction in Tinnitus Functional Index (TFI) scores has been defined as a successful outcome.ResultsOf the 228 subjects who were included in the study, 65% had a successful ICBT outcome. As per the univariate analysis, participants with a master's degree or above had the highest odds of having a larger reduction in tinnitus severity (OR 3.47; 95% CI 1.32 to 12.51), compared with the participants who had education only up to high school or less. Additionally, the baseline tinnitus severity was found to be a significant variable (OR 2.65; 95% CI 1.50 to 4.67) contributing to a successful outcome with the intervention. Both linear and logistic regression models have identified education level and baseline tinnitus severity to be significant predictor variables contributing to a reduction in tinnitus severity post-ICBT. As per the linear regression model, participants who had received disability allowance had shown a 25.3-point lower TFI reduction compared with those who did not experience a decrease in their workload due to tinnitus after adjusting for baseline tinnitus severity and their education level.ConclusionsPredictors of intervention outcome can be used as a means of triaging patients to the most suited form of treatment to achieve optimal outcomes and to make healthcare savings. Future studies should consider including a heterogeneous group of participants as well as other predictor variables not included in the current study.ClinicalTrial.gov Registration: NCT02370810 (completed); NCT02665975 (completed).

Project description:ObjectiveAshkenazi-Jewish (AJ) population-based BRCA testing is acceptable, cost-effective and amplifies primary prevention for breast & ovarian cancer. However, data describing lifestyle impact are lacking. We report long-term results of population-based BRCA testing on lifestyle behaviour and cancer risk perception.DesignTwo-arm randomised controlled trials (ISRCTN73338115, GCaPPS): (a) population-screening (PS); (b) family history (FH)/clinical criteria testing.SettingNorth London AJ-population.Population/sampleAJ women/men >18 years.Exclusionsprior BRCA testing or first-degree relatives of BRCA-carriers.MethodsParticipants were recruited through self-referral. All participants received informed pre-test genetic counselling. The intervention included genetic testing for three AJ BRCA-mutations: 185delAG(c.68_69delAG), 5382insC(c.5266dupC) and 6174delT(c.5946delT). This was undertaken for all participants in the PS arm and participants fulfilling FH/clinical criteria in the FH arm. Patients filled out customised/validated questionnaires at baseline/1-year/2-year/3-year follow-ups. Generalised linear-mixed models adjusted for covariates and appropriate contrast tests were used for between-group/within-group analysis of lifestyle and behavioural outcomes along with evaluating factors associated with these outcomes. Outcomes are adjusted for multiple testing (Bonferroni method), with P < 0.0039 considered significant.Outcome measuresLifestyle/behavioural outcomes at baseline/1-year/2-year/3-year follow-ups.Results1034 participants were randomised to PS (n = 530) or FH (n = 504) arms. No significant difference was identified between PS- and FH-based BRCA testing approaches in terms of dietary fruit/vegetable/meat consumption, vitamin intake, alcohol quantity/ frequency, smoking behaviour (frequency/cessation), physical activity/exercise or routine breast mammogram screening behaviour, with outcomes not affected by BRCA test result. Cancer risk perception decreased with time following BRCA testing, with no difference between FH/PS approaches, and the perception of risk was lowest in BRCA-negative participants. Men consumed fewer fruits/vegetables/vitamins and more meat/alcohol than women (P < 0.001).ConclusionPopulation-based and FH-based AJ BRCA testing have similar long-term lifestyle impacts on smoking, alcohol, dietary fruit/vegetable/meat/vitamin, exercise, breast screening participation and reduced cancer risk perception.

Project description:ObjectiveThere is currently limited research exploring healthcare professionals' (HCPs) experiences of working with patients with dissociative seizures (DS). Existing studies do not focus on the role of psychiatrists in treating this complex condition. The objective of this study was to gain an understanding of UK-based psychiatrists' experiences of the DS patient group. Against the backdrop of a UK-wide randomised controlled trial (RCT), the focus was broadened to encompass issues arising in everyday practice with the DS patient group.Design, participants and methodsA qualitative study using semistructured interviews was undertaken with 10 psychiatrists currently working with DS patients within the context of a large RCT investigating treatments for DS. Thematic analysis was used to identify key themes and subthemes.SettingThe psychiatrists were working in Liaison or Neuropsychiatry services in England.ResultsThe key themes identified were other HCPs' attitudes to DS and the challenges of the DS patient group. There is a clear knowledge gap regarding DS for many HCPs and other clinical services can be reluctant to take referrals for this patient group. Important challenges posed by this patient group included avoidance (of difficult emotions and help), alexithymia and interpersonal difficulties. Difficulties with alexithymia meant DS patients could struggle to identify triggers for their seizures and to express their emotions. Interpersonal difficulties raised included difficulties in attachment with both HCPs and family members.ConclusionsA knowledge gap for HCPs regarding DS has been identified and needs to be addressed to improve patient care. Given the complexity of the patient group and that clinicians from multiple disciplines will come into contact with DS patients, it is essential for any educational strategy to be implemented across the whole range of specialties, and to account for those already in practice as well as future trainees.Trial registration numberISRCTN05681227; NCT02325544; Pre-results.

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.

Dataset Information

Six-month outcomes of the CODES randomised controlled trial of cognitive behavioural therapy for dissociative seizures: A secondary analysis.

Purpose

Methods

Results

Conclusion

Publications

Six-month outcomes of the CODES randomised controlled trial of cognitive behavioural therapy for dissociative seizures: A secondary analysis.

Similar Datasets

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