Background
A subgroup of those with bipolar spectrum disorders experience ongoing mood
fluctuations outside of full episodes. We conducted a randomised, controlled feasibility study
of a Dialectical Behavioural Therapy-informed approach for bipolar mood fluctuations
(Therapy for Inter-episode mood Variability in Bipolar ...
Background
A subgroup of those with bipolar spectrum disorders experience ongoing mood
fluctuations outside of full episodes. We conducted a randomised, controlled feasibility study
of a Dialectical Behavioural Therapy-informed approach for bipolar mood fluctuations
(Therapy for Inter-episode mood Variability in Bipolar [ThrIVe-B]). Our study aimed to
examine the feasibility and acceptability of a future definitive trial evaluating the clinical and
cost effectiveness of the ThrIVe-B programme.
Participants were required to meet diagnostic criteria for a bipolar spectrum disorder
and report frequent mood swings outside of acute episodes. They were randomised to
treatment as usual (control arm) or the ThrIVe-B intervention plus treatment as usual
(intervention arm). Follow-up points were at 3, 6, 9 and 15 months after baseline, with 9
months as the primary end point. To evaluate feasibility and acceptability we examined
recruitment and retention rates, completion rates for study measures, adverse events and
feedback from participants on their experience of study participation and therapy.
Results
Of the target 48 participants, 43 were recruited (22 in the intervention arm; 21 in the
control arm), with a recruitment rate of 3.9 participants per month. At 9 months 74% of
participants engaged in research follow-up assessment, exceeding the pre-specified criterion
of 60%. There were no serious concerns about the safety of the research procedures or the
intervention. On one of the four candidate primary outcome measures, the 95% CI for the
between-group mean difference score excluded the null effect and included the minimal
clinically important difference, favouring the intervention arm, whilst on no measure was
there evidence of deterioration in the intervention arm relative to the control arm. Attendance
of the intervention (50% attending at least half of the mandatory sessions) was below the pre2 specified continuation criterion of 60%, and qualitative feedback from participants indicated
areas that may have hampered or facilitated engagement.
Conclusions
It is broadly feasible to conduct a trial of this design within the population of people
with frequent bipolar mood swings. Changes should be made to the therapy to increase
uptake, such as simplifying content and considering individual rather than group delivery.