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

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.

The impact of COVID-19 on the eating habits of families engaged in a healthy eating pilot trial: a thematic analysis.

BACKGROUND: The eating habits of children and adults have been impacted by the COVID-19 pandemic, with evidence of increases in snacking and emotional eating, including eating to relieve boredom. We explored the experiences of families with children aged 4-8 years who had recently participated in a healthy eating pilot trial when the first national lockdown began in England. METHODS: Eleven mothers were interviewed in April and May 2020. Interview questions were developed based on the COM-B model of behaviour. Four main themes were constructed using inductive thematic analysis. RESULTS: The first theme related to an initial panic phase, in which having enough food was the primary concern. The second related to ongoing challenges during the lockdown, with sub-themes including difficulties accessing food, managing children's food requests and balancing home and work responsibilities. The perception that energy-dense foods met families' needs during this time led to increased purchasing of (and thus exposure to) energy-dense foods. In the third theme, families described a turning point, with a desire to eat a healthier diet than they had in the early stages of the lockdown. Finally, in the fourth theme, families reported a number of strategies for adapting and encouraging a balanced diet with their children. CONCLUSIONS: Our results suggest that even if parents have the capability (e.g. knowledge) and motivation to provide a healthy diet for their family, opportunity challenges (e.g. time, access to resources, environmental stressors) mean this is not always practical. Healthy eating interventions should not assume parents lack motivation and should be sensitive to the context within which parents make feeding decisions.

Exploring Strategies to Optimise the Impact of Food-Specific Inhibition Training on Children's Food Choices.

Food-specific inhibition training (FSIT) is a computerised task requiring response inhibition to energy-dense foods within a reaction-time game. Previous work indicates that FSIT can increase the number of healthy foods (relative to energy-dense foods) children choose, and decrease calories consumed from sweets and chocolate. Across two studies, we explored the impact of FSIT variations (e.g., different response signals, different delivery modes) on children's food choices within a time-limited hypothetical food-choice task. In Study 1, we varied the FSIT Go/No-Go signals to be emotive (happy vs. sad faces) or neutral (green vs. red signs). One-hundred-and-fifty-seven children were randomly allocated to emotive-FSIT, neutral-FSIT, or a non-food control task. Children participated in groups of 4-15. No significant FSIT effects were observed on food choices (all values of p > 0.160). Healthy-food choices decreased over time regardless of condition (p < 0.050). The non-significant effects could be explained by lower accuracy on energy-dense No-Go trials than in previous studies, possibly due to distraction in the group-testing environment. In Study 2, we compared computer-based FSIT (using emotive signals) and app-based FSIT (using neutral signals) against a non-food control with a different sample of 206 children, but this time children worked one-on-one with the experimenter. Children's accuracy on energy-dense No-Go trials was higher in this study. Children in the FSIT-computer group chose significantly more healthy foods at post-training (M = 2.78, SE = 0.16) compared to the control group (M = 2.02, SE = 0.16, p = 0.001). The FSIT-app group did not differ from either of the other two groups (M = 2.42, SE = 0.16, both comparisons p > 0.050). Healthy choices decreased over time in the control group (p = 0.001) but did not change in the two FSIT groups (both p > 0.300) supporting previous evidence that FSIT may have a beneficial effect on children's food choices. Ensuring that children perform FSIT with high accuracy (e.g., by using FSIT in quiet environments and avoiding group-testing) may be important for impacts on food choices though. Future research should continue to explore methods of optimising FSIT as a healthy-eating intervention for children.

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.

Cost and outcome of behavioural activation versus cognitive behavioural therapy for depression (COBRA): a qualitative process evaluation.

OBJECTIVE: To explore participant views on acceptability, mechanisms of change and impact of behavioural activation (BA) delivered by junior mental health workers (MHWs) versus cognitive behavioural therapy (CBT) delivered by professional psychotherapists. DESIGN: Semistructured qualitative interviews analysed using a framework approach. PARTICIPANTS: 36 participants with major depressive disorder purposively sampled from a randomised controlled trial of BA versus CBT (the COBRA trial). SETTING: Primary care psychological therapies services in Devon, Durham and Leeds, UK. RESULTS: Elements of therapy considered to be beneficial included its length and regularity, the opportunity to learn and not dwelling on the past. Homework was an important, although challenging aspect of treatment. Therapists were perceived as experts who played an important role in treatment. For some participants the most important element of therapy was having someone to talk to, but for others the specific factors associated with BA and CBT were crucial, with behavioural change considered important for participants in both treatments, and cognitive change unsurprisingly discussed more by those receiving CBT. Both therapies were considered to have a positive impact on symptoms of depression and other areas of life including feelings about themselves, self-care, work and relationships. Barriers to therapy included work, family life and emotional challenges. A subset (n=2) of BA participants commented that therapy felt too simple, and MHWs could be perceived as inexperienced. Many participants saw therapy as a learning experience, providing them with tools to take away, with work on relapse prevention essential. CONCLUSIONS: Despite barriers for some participants, BA and CBT were perceived to have many benefits, to have brought about cognitive and behavioural change and to produce improvements in many domains of participants' lives. To optimise the delivery of BA, inexperienced junior MHWs should be supported through good quality training and ongoing supervision. TRIAL REGISTRATION NUMBER: ISRCTN27473954, 09/12/2011.

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

BACKGROUND: Cognitive 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/DESIGN: COBRA 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. DISCUSSION: The 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 REGISTRATION: Current Controlled Trials ISRCTN27473954.

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.