scholarly journals The heart & mind trial: intervention with cognitive–behavioural therapy in patients with cardiac disease and anxiety: randomised controlled trial protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e057085
Author(s):  
Selina Kikkenborg Berg ◽  
Margrethe Herning ◽  
Inge Schjødt ◽  
Charlotte Brun Thorup ◽  
Carsten Juul ◽  
...  
Keyword(s):  
Stress Response ◽  
Usual Care ◽  
Cognitive Behavioural Therapy ◽  
Cardiac Disease ◽  
Primary Outcome ◽  
Depression Scale ◽  
Behavioural Therapy ◽  
Repeated Measurements ◽  
National Committee ◽  
Cognitive Behavioural

IntroductionPatients with cardiac disease often experience anxiety (prevalence about 20%–25%) and have a doubled mortality risk when suffering from anxiety compared with patients without anxiety. This calls for interventions aiming to reduce anxiety.Methods and analysisThe Heart & Mind Trial consists of three parts: (1) screening of all hospitalised and outpatient cardiac patients with arrhythmia, heart failure or ischaemic heart disease at four university hospitals in Denmark using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A); Patients scoring ≥8 is invited to participate; (2) Assessment of the type of anxiety by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders and (3) Randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive–behavioural therapy (CBT) performed by a CBT-trained cardiac nurse plus usual care or, usual care alone. The primary outcome is anxiety measured with HADS-A at 5 months. Secondary outcomes include anxiety symptoms measured with Becks Anxiety Inventory and heart rate variability. Exploratory outcomes measured at 12 months include blood cortisol (stress response), blood C reactive protein (stress response), health-related quality of life, readmission, mortality and attributable direct costs. A total of 336 patients will be included. The primary analyses are based on the intention-to-treat principle. For the primary outcome, we will use a linear regression model. For the long-term outcomes, mixed regression models will be used including repeated measurements.Ethics and disseminationThe trial is performed in accordance with the Declaration of Helsinki. All patients must give informed consent prior to participation and the trial is initiated after approval by the Danish Data Protection Agency (P-2020-894) and the National Committee on Health Research Ethics (H-20066739). Positive, neutral and negative results of the trial will be published.Trial registration numberNCT04582734.

scholarly journals Cognitive behavioural therapy significantly reduces anxiety in patients with implanted cardioverter defibrillator compared with usual care: Findings from the Screen-ICD randomised controlled trial

2019 ◽  
Vol 27 (3) ◽  
pp. 258-268 ◽  
Author(s):  
Selina K Berg ◽  
Trine B Rasmussen ◽  
Margrethe Herning ◽  
Jesper H Svendsen ◽  
Anne V Christensen ◽  
...  
Keyword(s):  
Usual Care ◽  
Cognitive Behavioural Therapy ◽  
Primary Outcome ◽  
Depression Scale ◽  
Behavioural Therapy ◽  
Anxiety And Depression ◽  
Hospital Anxiety ◽  
Cardioverter Defibrillator ◽  
Cognitive Behavioural ◽  
Secondary Outcomes

Aim The aim of this study was to investigate the effect of a cognitive behavioural therapy intervention provided by trained cardiac nurses plus usual care compared with usual care alone in patients with an implanted cardioverter defibrillator who, prior to randomization, had presented with symptoms of anxiety measured by the Hospital Anxiety and Depression Scale. Background Around 20–25% of all patients with an implanted cardioverter defibrillator experience anxiety. Among these patients anxiety is associated with mortality, presumably explained by risk behaviour and activation of the autonomic nervous system. We hypothesised that cognitive behavioural therapy provided by cardiac nurses in an out-patient setting would be an effective treatment of anxiety. Methods This was an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive behavioural therapy plus usual care or to usual care. The primary outcome was Hospital Anxiety and Depression Scale-Anxiety mean score at 16 weeks. Secondary outcomes included Hospital Anxiety and Depression Scale-Depression, Becks Anxiety Inventory, HeartQoL and Hamilton Anxiety Scale. Primary outcome analysis was based on the intention-to-treat principle. Results A total of 88 participants were included, 66% men, mean age 64.3 years and 61% had primary indication implantable cardioverter defibrillator. A significant difference after 16 weeks was found between groups: intervention group (Hospital Anxiety and Depression Scale-A mean (standard deviation) 4.95 points (3.30) versus usual care group 8.98 points (4.03) ( p < 0.0001)). Cohen's d was –0.86, indicating a strong clinical effect. The effect was supported by secondary outcomes. Conclusion Cognitive behavioural therapy provided by cardiac nurses to patients with a positive screening for anxiety had a statistically and clinically significant effect on anxiety compared with patients not receiving cognitive behavioural therapy.

scholarly journals Cognitive–behavioural group treatment for a range of functional somatic syndromes: Randomised trial

2012 ◽  
Vol 200 (6) ◽  
pp. 499-507 ◽  
Author(s):  
Andreas Schröder ◽  
Emma Rehfeld ◽  
Eva Ørnbøl ◽  
Michael Sharpe ◽  
Rasmus W. Licht ◽  
...  
Keyword(s):  
Usual Care ◽  
Cognitive Behavioural Therapy ◽  
Group Treatment ◽  
Primary Outcome ◽  
Short Form ◽  
Randomised Trial ◽  
Bodily Pain ◽  
Behavioural Therapy ◽  
Functional Somatic Syndromes ◽  
Cognitive Behavioural

BackgroundMany specialty-specific functional somatic syndrome diagnoses exist to describe people who are experiencing so-called medically unexplained symptoms. Although cognitive–behavioural therapy can be effective in the management of such syndromes, it is rarely available. A cognitive–behavioural therapy suitable for group treatment of people with different functional somatic syndromes could address this problem.AimsTo test the efficacy of a cognitive–behavioural therapy (Specialised Treatment for Severe Bodily Distress Syndromes, STreSS) designed for patients with a range of severe functional somatic syndromes.MethodA randomised controlled trial (clinicaltrials.gov, NCT00132197) compared STreSS (nine 3.5 h sessions over 4 months, n = 54) with enhanced usual care (management by primary care physician or medical specialist, n = 66). The primary outcome was improvement in aggregate score on subscales of the 36-item Short Form Health Survey (physical functioning, bodily pain and vitality) at 16 months.ResultsParticipants receiving STreSS had a greater improvement on the primary outcome (adjusted mean difference 4.0, 95% CI 1.4–6.6, P = 0.002) and on most secondary outcomes.ConclusionsIn the management of functional somatic syndromes, a cognitive–behavioural group treatment was more effective than enhanced usual care.

Which cognitions and behaviours mediate the positive effect of cognitive behavioural therapy on fatigue in patients with multiple sclerosis?

2011 ◽  
Vol 42 (1) ◽  
pp. 205-213 ◽  
Author(s):  
H. Knoop ◽  
K. van Kessel ◽  
R. Moss-Morris
Keyword(s):  
Multiple Sclerosis ◽  
Cognitive Behavioural Therapy ◽  
Mediation Analysis ◽  
Relaxation Training ◽  
Illness Perception ◽  
Depression Scale ◽  
Behavioural Therapy ◽  
Common Symptom ◽  
Mediation Effects ◽  
Cognitive Behavioural

BackgroundChronic fatigue is a common symptom of multiple sclerosis (MS). A randomized controlled trial (RCT) showed that cognitive behavioural therapy (CBT) was more effective in reducing MS fatigue than relaxation training (RT). The aim of the current study was to analyse additional data from this trial to determine whether (1) CBT compared to RT leads to significantly greater changes in cognitions and behaviours hypothesized to perpetuate MS fatigue; (2) changes in these variables mediate the effect of CBT on MS fatigue; and (3) these mediation effects are independent of changes in mood.MethodSeventy patients (CBT, n=35; RT, n=35) completed the Cognitive and Behavioural Responses to Symptoms Questionnaire (CBSQ), the Brief Illness Perception Questionnaire (B-IPQ) modified to measure negative representations of fatigue, the Hospital Anxiety and Depression Scale (HADS), and the Chalder Fatigue Questionnaire (CFQ), pre- and post-therapy. Multiple mediation analysis was used to determine which variables mediated the change in fatigue.ResultsAvoidance behaviour and three cognitive variables (symptom focusing, believing symptoms are a sign of damage and a negative representation of fatigue) improved significantly more in the CBT than the RT group. Mediation analysis showed that changing negative representations of fatigue mediated the decrease in severity of fatigue. Change in anxiety covaried with reduction in fatigue but the mediation effect for negative representations of fatigue remained when controlling for improvements in mood.ConclusionsChange in beliefs about fatigue play a crucial role in CBT for MS fatigue. These beliefs and the role of anxiety deserve more attention in the further development of this intervention.

The Efficacy of Traditional Cognitive Behavioural Therapy for Depressed Adults with Anhedonia: A Systematic Review

2021 ◽  
Vol 7 (5) ◽  
pp. 520-544
Keyword(s):  
Systematic Review ◽  
Cognitive Behavioural Therapy ◽  
Primary Outcome ◽  
Behavioural Therapy ◽  
Major Depressive ◽  
Eligibility Criteria ◽  
Cognitive Behavioural ◽  
System Therapy ◽  
Randomised Controlled ◽  
The Impact

To date, the impact of traditional cognitive behavioural therapy (CBT) on anhedonia in major depressive disorder (MDD) has yet been systematically evaluated. This systematic review aims to examine the efficacy of traditional CBT for depressed adults with anhedonia. A literature search for randomised controlled trials of traditional CBT in adults with MDD from inception to July 2020 was conducted in 8 databases. The primary outcome was the levels of anhedonia. Ten studies with adults with MDD met the eligibility criteria. Our results indicate that traditional CBT is as effective as euthymic therapy, positive psychology therapy, self-system therapy,and medications for anhedonia in depression. Besides, our data provide further support for the development of augmented CBT to optimise treatment outcome for depressed adults with anhedonia. Received 11th June 2021; Revised 2nd September 2021; Accepted 20th September 2021

scholarly journals A Tailored, Therapist-Guided Internet-Based Cognitive Behavioral Intervention as an Addition to Care as Usual for Patients With Rheumatoid Arthritis: Economic Evaluation alongside an RCT (Preprint)

2018 ◽  
Author(s):  
Maaike Ferwerda ◽  
Sylvia van Beugen ◽  
Henriët van Middendorp ◽  
Henk Visser ◽  
Harald Vonkeman ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rheumatoid Arthritis ◽  
Usual Care ◽  
Cognitive Behavioural Therapy ◽  
Behavioural Therapy ◽  
Healthcare Use ◽  
Cognitive Behavioural ◽  
Related Quality ◽  
Health Related

BACKGROUND A chronic somatic condition, such as rheumatoid arthritis (RA), can significantly reduce health related quality of life due to psychological, social and physical consequences. Cognitive behavioural therapy can aid in improving outcomes for patients, for example in terms of disease trajectory, health care utilization, and workplace disability of patients. In recent years internet-based cognitive behavioural therapy has been proposed as an effective and efficient way to offer cognitive behavioural therapy and further implementation. However, little research has been conducted to support this proposition. OBJECTIVE To stimulate the implementation of effective treatment strategies for improving health-related quality of life (HRQoL) of patients with rheumatoid arthritis (RA), cost-benefit ratios are required to inform stake-holders. A cost-effectiveness study from a societal perspective was conducted alongside a randomized controlled trial on a tailored and therapist-guided internet-based cognitive behavioural intervention (ICBT) for patients with elevated levels of distress, as an addition to usual care alone. METHODS Data were collected at baseline/pre-intervention, 6 months/post-intervention, and three-monthly thereafter during one year follow-up. Effects were measured in quality-adjusted life years (QALYs) and costs from a societal perspective including healthcare sector costs (including healthcare use, medication, and intervention costs), patient travel costs for healthcare use, and costs associated with loss of labor. RESULTS The intervention improved quality of life compared to usual care alone (Δ QALYs= 0.059), but also led to higher costs (Δ= € 4.211,44), which reduced substantially when medication costs were left out of the equation (Δ= € 1.862,72). Most (93%) of the simulated ICERS were in the north-east quadrant, suggesting a high probability that the intervention is effective in improving HRQoL, but at a greater monetary cost for society compared to usual care alone. CONCLUSIONS A tailored and guided ICBT intervention as an addition to usual care for patients with RA with heightened distress was effective in gaining quality of life. Consequently, implementation of the ICBT into standard healthcare for patients with RA is recommended, yet further study into cost reductions in this population is warranted. CLINICALTRIAL National trial registry number:NTR2100

Long-term effects on income and sickness benefits after work-focused cognitive-behavioural therapy and individual job support: a pragmatic, multicentre, randomised controlled trial

2018 ◽  
Vol 75 (10) ◽  
pp. 703-708 ◽  
Author(s):  
Simon Øverland ◽  
Astrid Louise Grasdal ◽  
Silje Endresen Reme
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Behavioural Therapy ◽  
Work Participation ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundThere is moderate quality evidence that integrating work-directed interventions and components from psychological therapies reduces sickness absence in the medium term. We aimed to extend this evidence by examining objectively ascertained income and work participation status up to 4 years after an intervention to improve outcomes among people who struggle with work from common mental disorder.MethodsThe intervention combined components from cognitive behavioural therapy with principles from supported employment, and compared its efficacy with usual care. Outcomes were derived from registry data with no attrition, in a pragmatic multisite randomised controlled trial (N=1193).ResultsThe intervention group had higher income, higher work participation and more months without receiving benefits over the 10-month to 46-month long-term follow-up period after end of treatment, but differences were not statistically significant. For the group on long-term benefits at inclusion, effect sizes were larger and statistically significant.ConclusionThere were no statistically significant differences between the two groups in the primary outcome in the total population. In a secondary analysis for the subgroup most at risk of permanent work exclusion, long-term outcomes were favourable in the intervention group compared with usual care. The results support integrated work and health services for people on the severe end of work participation challenges.Trial registration numberNCT01146730.

scholarly journals Cognitive–behavioural therapy v. usual care in recurrent depression

2008 ◽  
Vol 193 (6) ◽  
pp. 505-506 ◽  
Author(s):  
Henk Jan Conradi ◽  
Peter de Jonge ◽  
Johan Ormel
Keyword(s):  
Primary Care ◽  
Usual Care ◽  
Beck Depression Inventory ◽  
Cognitive Behavioural Therapy ◽  
Acute Phase ◽  
Behavioural Therapy ◽  
Recurrent Depression ◽  
Cognitive Behavioural ◽  
Cognitive Problems

SummaryWe examined in a primary care sample whether acute-phase cognitive–behavioural therapy (CBT) would be more effective than usual care for patients with multiple prior episodes of depression. Depression outcome was based on a 3-monthly administered Beck Depression Inventory (BDI) during a 2-year follow-up. We confirmed that in patients with four or more prior episodes, CBT outperformed usual care by four points on the BDI, but not in patients with three or fewer prior episodes. Subsequent analyses suggested that CBT may be able to tackle cognitive problems related to rumination in patients with recurrent depression.

Effectiveness of Cognitive Behavioural Therapy for Suicide in Schizophrenia: A Systematic Review

2021 ◽  
Vol 18 ◽  
Author(s):  
Rafael Penadés ◽  
Florencia Forte ◽  
Gisela Mezquida ◽  
Alexandre González Rodríguez ◽  
Clemente García-Rizo ◽  
...  
Keyword(s):  
Suicide Prevention ◽  
Cognitive Behavioural Therapy ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Scientific Evidence ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Current Evidence ◽  
Adherence To Medication ◽  
Cognitive Behavioural

Background: Suicide is probably one of the worst potential complications for people with schizophrenia. Even though the use of antipsychotic medication is essential in reducing suicidal behaviour, the use of psychological treatments seems to be in the same way necessary. Cognitive Behavioural Therapy (CBT) is an evidence-based form of psychotherapy that is constantly trying to synchronise with the latest recommendations from the research. The goal of the present work is to systematically review the scientific evidence from published studies testing the effectiveness of CBT designed to deal with suicide in patients with schizophrenia. Methods: We searched using multiple terms related to suicide prevention based on CBT in schizophrenia. Two databases (Medline and SCOPUS) were scrutinised for the electronic search and different reference lists from previous reviews were also hand checked. Results: We identified 5 randomised and controlled trials of CBT that included suicide-related cognitions or behaviours as a primary outcome measure. CBT focusing on suicidal cognitions and behaviours was found to be effective in reducing suicidal ideation. As the number of studies fulfilling the inclusion criteria is small and the assessment of outcomes is heterogeneous, we did not perform a meta-analysis and we present results in a narrative way. Conclusion: Research on CBT focused on suicide prevention in patients with schizophrenia is promising but current evidence is notoriously insufficient. Although those therapies seemed to be efficacious in the prevention of suicide, scarcity of randomised clinical trials specifically focusing on suicide is probably the most important issue to be faced. Given the current evidence, clinicians should be familiar with CBT techniques focusing on suicidal cognitions. However, suicide prevention and treatment in those with schizophrenia is complex, and many other factors such as possible earlier use of clozapine, optimizing adherence to medication, and other psychosocial aspects should be addressed. Combination of different strategies appears to be mandatory.

scholarly journals Cost-effectiveness of cognitive–behavioural therapy for sleep disorder added to usual care in patients with schizophrenia: the BEST study

BJPsych Open ◽  
2018 ◽  
Vol 4 (3) ◽  
pp. 126-135 ◽  
Author(s):  
Apostolos Tsiachristas ◽  
Felicity Waite ◽  
Daniel Freeman ◽  
Ramon Luengo-Fernandez
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Cognitive Behavioural Therapy ◽  
Patient Group ◽  
Sleep Problems ◽  
Cost Effective ◽  
Behavioural Therapy ◽  
Potential Cost ◽  
Cognitive Behavioural ◽  
Hypnotic Medication

BackgroundSleep problems are pervasive in people with schizophrenia, but there are no clinical guidelines for their treatment. The Better Sleep Trial (BEST) concluded that suitably adapted cognitive–behavioural therapy (CBT) is likely to be highly effective, although its cost-effectiveness is unknown.AimsTo assess the potential cost-effectiveness of CBT for sleep disorders in patients with schizophrenia.MethodAn economic evaluation of the BEST study with a 6-month time horizon was used to establish the cost-effectiveness of CBT plus usual care in terms of costs per quality-adjusted life year (QALY) gained. Uncertainty was displayed on cost-effectiveness planes and acceptability curves. Value of information analysis was performed to estimate the benefits of obtaining further evidence.ResultsOn average, the treatment led to a 0.035 QALY gain (95% CI −0.016 to 0.084), and £1524 (95% CI −10 529 to 4736) and £1227 (95% CI −10 395 to 5361) lower costs from National Health Service and societal perspectives, respectively. The estimated value of collecting more information about the effects of the CBT on costs and QALYs was approximately £87 million.ConclusionsCBT for insomnia in people with schizophrenia is effective and potentially cost-effective. A larger trial is needed to provide clear evidence about its cost-effectiveness.RelevancePatients with schizophrenia have multiple complex health needs, as well as very high rates of depression, suicidal ideation and poor physical health. The results of this study showed that treating pervasive sleep problems in this patient group with cognitive–behavioural therapy (CBT) is very likely to improve patient quality of life in the short term. Clinicians most commonly use hypnotic medication to treat sleeping disorders. This study indicates that CBT may be an effective and cost-effective intervention in this patient group. This alternative would also be aligned with patient preferences for psychological and behavioural-type therapy.Declaration of interestNone.

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