Psychological therapy for mood instability within bipolar spectrum disorder: a single-arm feasibility study of a dialectical behaviour therapy-informed approach

Abstract

Background: We sought to evaluate the acceptability of a psychological therapy programme (Therapy for Interepisode Mood Variability in Bipolar Disorder (ThrIVe-B)) for individuals with ongoing bipolar mood instability and the feasibility and acceptability of potential trial procedures. We also evaluated the performance of clinical and process outcome measures and the extent to which the programme potentially represents a safe and effective intervention. Method:We conducted an open (uncontrolled) trial in which 12 individuals with a bipolar spectrum diagnosis commenced the ThrIVe-B programme after completing baseline assessments. The programme comprised 16 group skills training sessions plus individual sessions and a supporting smartphone application. Follow-up assessments were at therapy end-point and 6 months post-treatment.Results: Nine participants completed treatment. Ten provided end-of-treatment data; of these, nine were satisfied with treatment. Interviews with participants and clinicians indicated that the treatment was broadly feasible and acceptable, with suggestions for improvements to content, delivery and study procedures. Exploration of change in symptoms was consistent with the potential for the intervention to represent a safe and effective intervention. Conclusions: Conducting further evaluation of this approach in similar settings is likely to be feasible, whilst patient reports and the pattern of clinical change observed suggest this approach holds promise for this patient group. Future research should include more than one study site and a comparison arm to address additional uncertainties prior to a definitive trial.Trial registration: Trial Registration: ClinicalTrials.gov NCT02637401; registered 22.12.15 (retrospectively registered).

Psychological therapy for mood instability within bipolar spectrum disorder: a randomised, controlled feasibility trial of a dialectical behaviour therapy-informed approach (the ThrIVe-B programme)

“…Nevertheless some participants in both arms reported finding the self-report measures onerous; this could potentially be improved by reducing the number of measures, using a more sophisticated online data collection platform, and making more use of participant payment. Whilst participants reported many positive aspects of the therapy, overall therapy attendance rates were numerically lower than the previous open trial (Wright et al 2020), which may be the result of the imprecision inherent in estimates derived from small samples, but may also request variation in ease of recruitment in this multi-site trial. Nevertheless, as they were also below those specified a-priori in continuation rule four (at least 60% of patients complete at least 50% of sessions) improvement of the therapy content and delivery is required.…”

“…On the basis of our previous work (Wright et al 2020) we estimated an attrition rate of 17% with respect to the 9 month primary end point. A sample of 48 would allow estimation of this level of attrition for a future definitive trial with a precision of ± 15% with 95% certainty.…”

“…Initial evaluation of the ThrIVe-B programme in an uncontrolled feasibility study (N = 12) (Wright et al 2020) found it to be acceptable to recipients: 75% completed therapy. Consistent with potential for clinical benefit, reliable improvement in depression, anxiety and general mental health symptoms was observed in least half the participants, with very few instances of reliable deterioration on any measure.…”

A systematic review on the effectiveness of dialectical behavior therapy for improving mood symptoms in bipolar disorders

“…A DBT-informed program adapted to target inter-episode mood instability in BD (Therapy for Inter-episode mood Variability in Bipolar (ThrIVe-B)) was assessed in an observational feasibility trial (n = 12) and an RCT (n = 43) (Wright et al 2020 ; Wright et al 2021 ). Both trials included adult participants with BD who had experienced several subthreshold hypomanic and depressive episodes over the preceding 2 years.…”

A Shelter in the Storm – Acceptability and Feasibility of a Brief Clinical Intervention for Suicidal Crisis

“…This question has been found to be a strong predictor of suicide attempt and death over the following 12 months (Louzon et al, 2016; Rossom et al, 2017). Previous studies have also utilized a single item for suicidal ideation taken from a longer validated measure (Huxley et al, 2019; Wright et al, 2020).…”