Evaluating the effectiveness of Imagery Focussed therapy in patients suffering from bipolar disorder: An exploratory trial

Bipolar Disorder (BD) is a severe mental health illness affecting 1.9% to 2.4%
of the population and is associated with high inter episode distress, on going
mood swings (mood variability), high suicide risks and high co-morbidity
(especially anxiety). 50% of patients do not recover within one year, and only
25% of patients achieve full recovery of function, despite receiving the
recommended lead intervention consisting of pharmacotherapy (mood stabilisers
such as lithium). Added psychoeducation and cognitive behavioural interventions
(CBT) have only modest effects. Overall there is consensus for the need to
update CBT and increase its effectiveness, aimed at not only managing symptoms
but also targeting perpetuating or precipitating factors influencing symptoms,
especially mood variability.
Recent studies suggest that patients with BD experience more vivid, compelling
and upsetting mental images compared to patients suffering from unipolar
depression and healthy controls and that this may contribute to or even
maintain their clinical difficulties. That is, imagery in experimental research
has proven to have a stronger effect on mood changes than verbal cognitions.
The amplified imagery vividness of patients suffering from BD might therefore
precipitate or perpetuate their mood variability. In many other mental health
problems imagery interventions as a stand-alone intervention, or added to
regular CBT, are offered with the aim to decrease imagery vividness or
modify/update appraisals of imagery. In BD patients such interventions,
therefore, might also target important precipitating or perpetuating factors
influencing their mood problems.
In 2016 Holmes et al. (2016) introduced a brief imagery-based cognitive
intervention (ImCT) for patients suffering from bipolar disorder, using
techniques aimed at both, quality of the imagery and appraisals of the imagery.
ImCT is a promising intervention as it allows for flexible fine tuning to
target specific elements of imagery. ImCT incorporates an elaborate
micro-formulation of imagery (teasing out both qualitative aspects of imagery
as well as appraisals), followed by metacognitive intervention, imagery
rescripting or positive imagery and competing task (or a combination of these),
tailoring the intervention depending on the outcome of the micro formulation.
Holmes and colleagues (2016) conducted a pilot using a non-concurrent baseline
design, with a series of A-B replication. Fourteen patients with bipolar
disorder were randomly assigned to 4, 5, or 6 weeks baseline after which they
received ImCT (in total 10 to 14 sessions). Outcome measures were weekly
measures of mood (mania, depression, and anxiety) and changes in targeted
imagery. In addition, daily mood measures were collected using a smart phone
text messaging to accurately measure mood variability. Holmes et al concluded
that daily measurements were feasible. Patients reported an increase in mood
stability, as well as improvements on weekly, and pre- and post measures of
mood and target imageryImCT appears promising and invites further evaluation.
In the present research proposal, we elaborate on the previous ImCT-study,
comparing its effectiveness in patients with bipolar disorder to
psychoeducation and pharmacotherapy, which is considered Treatment As Usual
(TAU) according to Dutch guidelines (Kupka et al., 2015). In advance of g a
large randomised controlled trial it is necessary to derive more precise
estimates of retention rates, especially on daily monitoring, and information
on general feasibility as well as first data comparing ImCT to an appropriate
control condition.

Our study aims to assess the effectiveness of a brief Imagery-focussed
Cognitive Therapy (ImCT) compared to psychoeducation, regarded as treatment as
usual for this patient population, in patients suffering from Bipolar Disorder.
ImCT was successfully tested in a pilot study using a case series design. We
now elaborate on this study comparing effectiveness of the intervention to
psychoeducation. We hypothesise (1a) mood variability (primary outcome
variable) and (1b) symptoms of depression, mania and anxiety (secondary outcome
variables) show stronger decreases in BD patients receiving ImCT than in
patients receiving psychoeducation/TAU. Moreover, (2) in the ImCT group this
effect is expected to be mediated by changes in imagery that is targeted during
this intervention (target imagery). We also hypothese that (3) imagery
frequency and compellingness and vividness of imagery change more in the ImCT
group than in the group receiving psychoeducation/TAU. Our primary outcome
variable, mood variability, is calculated using daily mood measurements, during
a 4-week baseline, during the invention and after the end of intervention until
follow up at 16 weeks, in both ImCT and psychoeducation/TAU. Most secondary
outcome variables are assessed using weekly online questionnaires, pre-and post
intervention and at 8 and 16 weeks follow-up, anxiety is calculated both weekly
online and using daily measurements (see below).

The present research proposal concerns a randomised exploratory trial,
comparing ImCT intervention to treatment as usual (TAU) consisting of
psycho-education. In addition to the between group design, we will also use a
within-group design were ImCT or psychoeducation is preceded by a no-treatment/
baseline condition. The within-group desgn allows participants baselines to act
as their individual control periods with no intervention (Barlow, Nock, &
Hersen, 2009; Bonsal et al, 2012, Holmes et all, 2016).

Both groups (ImCT and TAU) consult a psychiatrist and receive advice and
guidance on medication, which is monitored and adjusted conform guidelines
(NICE) throughout this study.

Description of ImCT:
The ImCT group receives in addition to pharmacotherapy, an in depth
identification (4 sessions) of images followed by imagery interventions (4-6
sessions) and a consolidation phase (1 session) developed by Holmes, Young,
Hales and DiSimplico described in the MAPP manual [reference]. The imagery
intervention consists of metacognitive imagery rescripting or promoting
positive imagery or competing tasks (or a combination of these).
Therapists are qualified psychologist properly trained in ImCT and receiving
weekly supervision from a clinical psychologist trained in ImCT.

Detailed description of psychoeducation/TAU:
TAU consists of pharmacotherapy and psycho-education. Psycho-education is
offered in groups, using the format described by Honig (Postma, Honig, & van
Gent, 2008), for a period of 6 weeks consisting of 2-hourly sessions. In the
first three sessions patients are receiving information on bipolar disorder,
symptoms, prevalence, aetiology and mood stabilisers. The remaining sessions
focus on (early) recognition of mood variations, and management or coping
strategies. Finally medication adherence and relapse strategies are discussed.

Daily mood monitoring and psychoeducation are both standard interventions
offered for patients suffering from bipolar disorder. The ImCt interventions is
comparable to psychoeducation. The added burden for participants in this study
are the online questionnaires, pre- and post intervention and at follow up, and
the weekly online questionnaires. We do not expect risks, as all patients
receive regular sessions with a psychiatrist to monitor and if needed adjust
medication. If patients relapse standard care will be provided (added
supportive contacts, medications adjustment or if need be an admission) to
treat relapse. If patients relapse and are admitted for longer than one week,
they can continue with the interventions (should patient desire so and
psychiatrist agree this will be helpful) but they will be excluded from the
research study.