Kim Wright

Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial

Summary Background Depression is a common, debilitating, and costly disorder. Many patients request psychological therapy, but the best-evidenced therapy—cognitive behavioural therapy (CBT)—is complex and costly. A simpler therapy—behavioural activation (BA)—might be as effective and cheaper than is CBT. We aimed to establish the clinical efficacy and cost-effectiveness of BA compared with CBT for adults with depression. Methods In this randomised, controlled, non-inferiority trial, we recruited adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder from primary care and psychological therapy services in Devon, Durham, and Leeds (UK). We excluded people who were receiving psychological therapy, were alcohol or drug dependent, were acutely suicidal or had attempted suicide in the previous 2 months, or were cognitively impaired, or who had bipolar disorder or psychosis or psychotic symptoms. We randomly assigned participants (1:1) remotely using computer-generated allocation (minimisation used; stratified by depression severity [Patient Health Questionnaire 9 (PHQ-9) score of <19 vs ≥19], antidepressant use, and recruitment site) to BA from junior mental health workers or CBT from psychological therapists. Randomisation done at the Peninsula Clinical Trials Unit was concealed from investigators. Treatment was given open label, but outcome assessors were masked. The primary outcome was depression symptoms according to the PHQ-9 at 12 months. We analysed all those who were randomly allocated and had complete data (modified intention to treat [mITT]) and also all those who were randomly allocated, had complete data, and received at least eight treatment sessions (per protocol [PP]). We analysed safety in the mITT population. The non-inferiority margin was 1·9 PHQ-9 points. This trial is registered with the ISCRTN registry, number ISRCTN27473954. Findings Between Sept 26, 2012, and April 3, 2014, we randomly allocated 221 (50%) participants to BA and 219 (50%) to CBT. 175 (79%) participants were assessable for the primary outcome in the mITT population in the BA group compared with 189 (86%) in the CBT group, whereas 135 (61%) were assessable in the PP population in the BA group compared with 151 (69%) in the CBT group. BA was non-inferior to CBT (mITT: CBT 8·4 PHQ-9 points [SD 7·5], BA 8·4 PHQ-9 points [7·0], mean difference 0·1 PHQ-9 points [95% CI −1·3 to 1·5], p=0·89; PP: CBT 7·9 PHQ-9 points [7·3]; BA 7·8 [6·5], mean difference 0·0 PHQ-9 points [–1·5 to 1·6], p=0·99). Two (1%) non-trial-related deaths (one [1%] multidrug toxicity in the BA group and one [1%] cancer in the CBT group) and 15 depression-related, but not treatment-related, serious adverse events (three in the BA group and 12 in the CBT group) occurred in three [2%] participants in the BA group (two [1%] patients who overdosed and one [1%] who self-harmed) and eight (4%) participants in the CBT group (seven [4%] who overdosed and one [1%] who self-harmed). Interpretation We found that BA, a simpler psychological treatment than CBT, can be delivered by junior mental health workers with less intensive and costly training, with no lesser effect than CBT. Effective psychological therapy for depression can be delivered without the need for costly and highly trained professionals. Funding National Institute for Health Research.

Psychological therapies in bipolar disorder: the effect of illness history on relapse prevention – a systematic review

OBJECTIVES Despite some encouraging outcomes and shared components of psychological therapies specific to bipolar disorders, not all studies found conclusively that the addition of a psychosocial intervention to pharmacological interventions improves outcomes. There was some tentative evidence from post hoc analyses that patients with more than 12 previous episodes did not benefit from psychoeducation or cognitive therapy. This paper presents a systematic review and meta-analysis which examines the overall efficacy of bipolar disorder-specific psychological therapies and the impact of the number of previous episodes on the efficacy of psychological therapies in relapse prevention. METHODS Systematic literature searches of electronic databases and reference lists of existing reviews were carried out. The number of participants experiencing relapse in randomized, controlled studies was combined in a meta-analysis to determine the overall treatment effect in relapse prevention. Metaregression modeling was used to examine whether the number of previous episodes confounded the number of relapses experienced by participants by the end of treatment. RESULTS Meta-analysis of relapse calculated an overall relative risk of 0.74 [95% confidence interval (CI): 0.64-0.85] with some heterogeneity present (I(2) = 43.3%). Metaregression of six studies showed no relationship between number of episodes and number of relapses by endpoint. CONCLUSION Psychological therapy specifically designed for bipolar disorder is effective in preventing or delaying relapses in bipolar disorders, and there is no clear evidence that the number of previous episodes moderated the effect.

Induced mood change and dysfunctional attitudes in remitted bipolar I affective disorder.

This study investigated the possibility that, in remitted bipolar I affective disorder, dysfunctional attitudes are mood-state dependent. Participants were 120 individuals with remitted bipolar I disorder, remitted unipolar depression, or no history of affective disorder. The Dysfunctional Attitudes Scale (DAS; Weissman, 1979) was completed before and after positive or negative mood challenge. Following mood increase, the bipolar group changed significantly less in DAS total score than did the other 2 groups, and in goal-striving and achievement attitudes relative to the unipolar group. These findings did not provide clear support for the mood-state dependency theory in bipolar disorder, arguing instead for the presence in bipolar I disorder of dysfunctional cognitions that show characteristic resilience in the face of minor positive mood increase.

'It's a double edged sword': A qualitative analysis of the experiences of exercise amongst people with Bipolar Disorder

BACKGROUND Little is known about the therapeutic or iatrogenic effects of exercise in individuals with Bipolar Disorder, despite its potential to benefit physical and mental health. Consequently the aim of the current study was to gather data on experiences of the relationship between exercise and Bipolar Disorder from people with personal experience of the condition. In particular we sought to determine the aspects of this relationship that are pertinent to Bipolar Disorder. METHODS Twenty five individuals with a diagnosis of Bipolar Disorder participated in a semi-structured interview concerning their views on the relationship between exercise and Bipolar Disorder. The data were subjected to qualitative analysis using an Interpretative Phenomenological Analysis approach. RESULTS Both a descriptive content analysis and a population-specific thematic analysis were conducted. The latter revealed three themes, all present in the majority of participants, which reflected key aspects of the relationship between Bipolar Disorder and exercise: regulating exercise for mood regulation, exercise as a double-edged sword, and bringing structure to chaos. LIMITATIONS Information on past and current treatment regimes was not collected, and additional lifestyle factors, such as diet and alcohol use, were not investigated. Interviews were conducted by telephone. CONCLUSIONS The data reveal a number of aspects of the relationship between exercise and Bipolar Disorder that require further investigation and that should be taken into account by clinicians or researchers designing exercise-based interventions for individuals with Bipolar Disorder.

Reactivity of affect and self-esteem during remission in bipolar affective disorder: An experimental investigation

BACKGROUND Bipolar affective disorder (BPAD) is characterised by a lifelong vulnerability to develop episodes of depressed or elevated mood in response to stressful life events involving achievement or failure. We hypothesised that this latent vulnerability can manifest as reactivity of affect and self-esteem to experimentally induced experiences of success and failure and is shaped by history of childhood adversity. METHODS Twenty-four people with remitted BPAD and twenty-four healthy controls underwent anagram-solving tasks designed to generate experiences of success and failure in two separate sessions. Positive and negative affect and implicit and explicit self-esteem were measured before and after each task. Early adversity was measured by Childhood Trauma Questionnaire. RESULTS People with BPAD showed larger reactivity of affect and explicit self-esteem in response to experimental success and failure than did healthy controls. There were no significant differences in reactivity of implicit self-esteem. History of childhood trauma predicted increased affective reactivity to failure but not to success. LIMITATIONS We used a convenience sample. CONCLUSIONS The present experimental paradigm reveals reactivity of affect and self-esteem as features of BPAD, which are present even during good remission and thus are accessible as targets of interventions aiming at relapse prevention. Differential associations with childhood adversity indicate aetiological heterogeneity, with reactivity to failure influenced by early trauma and reactivity to success driven by other mechanisms.

Dysregulation of the Behavioral Activation System in Remitted Bipolar I Disorder

The current study tests a prediction of the behavioral activation system (BAS) dysregulation theory of bipolar disorder, namely that following high levels of reward or frustration, individuals with bipolar disorder will take longer than will healthy controls to recover to baseline levels of BAS activity. Eighty individuals (40 with bipolar I disorder, currently euthymic; 40 with no history of affective disorder) completed a daily diary over a 28 day period. No differences were found between the 2 groups in terms of the relation among levels of reward or frustration experienced, magnitude of initial response, or time taken to recover. However, examination of the relation between number of previous episodes and time to recover revealed that history of mania was associated with prolonged activation following reward, whereas history of both mania and depression were associated with prolonged recovery following frustration. The findings do not support an association between lifetime diagnosis of bipolar disorder and slow recovery of BAS activity. Nevertheless, they offer tentative support for an association between number of previous episodes and slow recovery of BAS activity.

The development of a scale for measuring offence-related feelings of shame and guilt

Abstract There is substantial evidence that shame and guilt are distinct emotions. Within the field of forensic psychology, it has been suggested that feelings of shame and guilt about a crime differ in their implications for the offenders behaviour. However, investigation of this issue is hampered by the absence of separate, dedicated measures of offence-related guilt and shame. The aim of this study was to develop and validate a preliminary measure of shame and guilt about a crime. The Offence-Related Shame and Guilt Scale was completed by 60 men detained on forensic psychiatric units, as were two existing general measures of shame and guilt. Exploratory factor analysis revealed the existence of two substantive shame and guilt dimensions. The resulting scales were found to have adequate internal consistency and test – retest reliability. Overall the results of this study suggest that while there is considerable overlap between the two emotions, shame and guilt represent distinct emotional responses to an offence.

Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial.

BackgroundCognitive behaviour therapy (CBT) is an effective treatment for depression. However, CBT is a complex therapy that requires highly trained and qualified practitioners, and its scalability is therefore limited by the costs of training and employing sufficient therapists to meet demand. Behavioural activation (BA) is a psychological treatment for depression that may be an effective alternative to CBT and, because it is simpler, might also be delivered by less highly trained and specialised mental health workers.Methods/DesignCOBRA is a two-arm, non-inferiority, patient-level randomised controlled trial, including clinical, economic, and process evaluations comparing CBT delivered by highly trained professional therapists to BA delivered by junior professional or para-professional mental health workers to establish whether the clinical effectiveness of BA is non-inferior to CBT and if BA is cost effective compared to CBT. Four hundred and forty patients with major depressive disorder will be recruited through screening in primary care. We will analyse for non-inferiority in per-protocol and intention-to-treat populations. Our primary outcome will be severity of depression symptoms (Patient Health Questionnaire-9) at 12 months follow-up. Secondary outcomes will be clinically significant change and severity of depression at 18 months, and anxiety (General Anxiety Disorder-7 questionnaire) and health-related quality of life (Short-Form Health Survey-36) at 12 and 18 months. Our economic evaluation will take the United Kingdom National Health Service/Personal Social Services perspective to include costs of the interventions, health and social care services used, plus productivity losses. Cost-effectiveness will explored in terms of quality-adjusted life years using the EuroQol-5D measure of health-related quality of life.DiscussionThe clinical and economic outcomes of this trial will provide the evidence to help policy makers, clinicians and guideline developers decide on the merits of including BA as a first-line treatment of depression.Trial registrationCurrent Controlled Trials ISRCTN27473954

An investigation of the relationship between anger and offence-related shame and guilt

Abstract A number of accounts of shame and guilt emphasise an association between shame and anger difficulties, and it has been suggested that shame and rage may promote one another. The shame–anger relationship may be particularly relevant to the study of forensic populations, as the fact of having committed a criminal offence has the potential to be a highly shame-provoking experience. The current study investigates the prediction that shame and guilt reactions to an offence are differentially related to the propensity to experience and ability to control anger. A measure of offence-related shame and guilt and a measure of anger experience and control was completed by 60 men detained in forensic psychiatric units. The results supported the prediction that offence-related shame is associated with elevated levels of anger difficulties, whilst offence-related guilt is associated with ability to control anger. The findings of the current study are consistent with those of previous investigations of shame, guilt and anger. Specific implications for the understanding and prevention of violent offending are discussed.

Relating the Bipolar Spectrum to Dysregulation of Behavioural Activation: A Perspective from Dynamical Modelling

Bipolar Disorders affect a substantial minority of the population and result in significant personal, social and economic costs. Understanding of the causes of, and consequently the most effective interventions for, this condition is an area requiring development. Drawing upon theories of Bipolar Disorder that propose the condition to be underpinned by dysregulation of systems governing behavioural activation or approach motivation, we present a mathematical model of the regulation of behavioural activation. The model is informed by non-linear, dynamical principles and as such proposes that the transition from “non-bipolar” to “bipolar” diagnostic status corresponds to a switch from mono- to multistability of behavioural activation level, rather than an increase in oscillation of mood. Consistent with descriptions of the behavioural activation or approach system in the literature, auto-activation and auto-inhibitory feedback is inherent within our model. Comparison between our model and empirical, observational data reveals that by increasing the non-linearity dimension in our model, important features of Bipolar Spectrum disorders are reproduced. Analysis from stochastic simulation of the system reveals the role of noise in behavioural activation regulation and indicates that an increase of nonlinearity promotes noise to jump scales from small fluctuations of activation levels to longer lasting, but less variable episodes. We conclude that further research is required to relate parameters of our model to key behavioural and biological variables observed in Bipolar Disorder.