A randomised controlled trial of time limited CBT informed psychological therapy for anxiety in bipolar disorder

Abstract

BackgroundAnxiety comorbidity is common in bipolar disorder and is associated with worse treatment outcomes, greater risk of self harm, suicide and substance misuse. To date however there have been no psychological interventions specifically designed to address this problem. The primary objective of this trial is to establish the acceptability and feasibility of a new integrated intervention for anxiety in bipolar disorder designed in collaboration with individuals with personal experience of both problems.Methods and designSingle blind randomised controlled trials to assess the feasibility and acceptability of a time limited CBT informed psychological intervention for anxiety in bipolar disorder (AIBD) compared with treatment as usual. Participants will be recruited from across the North West of England from specialist mental health services and through primary care and self referral. The primary outcome of the study is the feasibility and acceptability of AIBD assessed by recruitment to target and retention to follow-up, as well as absence of untoward incidents associated with AIBD. We will also estimate the effect size of the impact of the intervention on anxiety and mood outcomes, as well as calculate preliminary estimates of cost-effectiveness and investigate potential mechanisms for this (stigma, self appraisal and stability of social rhythms).DiscussionThis is the first trial of an integrated intervention for anxiety in bipolar disorder. It is of interest to researchers involved in the development of new therapies for bipolar disorder as well as indicating the wider potential for evaluating approaches to the treatment of comorbidity in severe mental illness.Trial registration numberISRCTN84288072

The feasibility and acceptability of a novel anxiety in bipolar disorder intervention compared to treatment as usual: A randomized controlled trial

“…Recruitment target was met (n = 72; 59% of those screened for eligibility). Retention was 88% ( n = 63) to end of therapy (16 weeks), 78% ( n = 56) to 32‐week follow‐up, 75% ( n = 54) to 48‐ and 64‐week follow‐up, and 74% ( n = 53) to 80‐week follow‐up (feasibility target 75 ± 10% to 80 weeks (Jones et al., )). Retention rates are at least as high in TAU as in AIBD (Figure ).…”

“…This study was preregistered (ISRCTN: 84288072), reviewed, and approved by UK NHS Ethics (REC ref: 10/H1015/83) with a published research protocol (Jones et al., ).…”

“…Additional clinical outcomes were personal recovery (Bipolar Recovery Questionnaire [BRQ]; Jones et al., ); quality of life (Quality of Life in Bipolar Disorder Scale [QoL.BD]; Michalak, Murray, & Crest, ), and functioning (Personal and Social Performance Scale [PSP]; Morosini, Magliano, Brambilla, Ugolini, & Pioli, ).…”

Harnessing the potential of community-based participatory research approaches in bipolar disorder

“…While genetics, neurobiology, and clinical phenomenology are currently the dominant research foci, community members emphasize the need for more pragmatic, real-world studies, the development of new medication and psychological treatments, as well as for research on lifestyle and psychosocial factors (Banfield et al 2014 ), prevention (Jacka et al 2013 ), and positive features of BD (Lobban et al 2012a ), such as creativity (Johnson et al 2015a ). In the UK, service users have encouraged the development of BD research on recovery, anxiety treatment, and risk factors for suicide (Clements et al 2013 ; Jones et al 2012 , 2013a , 2013b ). In Canada, research on self-management, stigma, QoL, and psychosocial treatment has been prioritized by CBPR initiatives (Michalak et al 2012 ).…”

Cognitive Emotion Regulation as a Mediator between Posttraumatic Stress Symptoms and Hypomanic Personality within a Non-Clinical Population

“…Whilst intrusive memories of traumatic events were independently related to hypomanic personality, this variable only made a small contribution to the overall variance. Interestingly, hypomanic personality was strongly related to anxiety but not depression, supporting the rationale for interventions specifically targeting anxiety within the treatment of bipolar disorder (Jones et al, 2013).…”