Clinical trial NCT03750305: Evaluating the Effectiveness of Imagery Focussed Therapy
Official title: Evaluating the Effectiveness of Imagery Focussed Therapy in Patients Suffering From Bipolar Disorder: an Exploratory Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between groups, comparing Imagery-Focussed therapy with psychoeducation/TAU/within group, comparing baseline phase with treatment phase.
Primary purpose: TREATMENT

Brief summary: This study explores 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 BD receiving mood stabilising medication. ImCT was successfully tested in a pilot study using a case series design. The investigators now elaborate on this study comparing effectiveness of the intervention to psychoeducation/TAU.

Detailed description: 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, ongoing 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.

This 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 BD receiving mood stabilising medication. ImCT was successfully tested in a pilot study using a case series design. The investigators now elaborate on this study comparing effectiveness of the intervention to psychoeducation/TAU. The investigators hypothesise that (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 which is targeted during this intervention (target imagery). The investigators also hypothese that (3) imagery frequency and compellingness and vividness of imagery reduce more in the imCT group than in the group receiving psychoeducation/TAU. The 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).

Eligibility criteria: Inclusion Criteria:

* Aged 18-68
* Sufficient Dutch language ability to permit the assessment to be completed.
* Diagnosis of DB (I or II or NOS) according to DSM-5 (clinicians assessment).
* Willing to complete daily and weekly monitoring throughout the duration of the study.
* Successful completion of the daily monitoring in the 4 weeks active run-in phase.
* Willing to be randomised to either imCT or psychoeducation/TAU condition
* Can commit to attending 12 consecutive weekly sessions imCT or psychoeducation/TAU.

Exclusion Criteria:

* Learning difficulties, organic brain disease or severe neurological impairment.
* Current severe substance or alcohol misuse (clinicians assessment).
* Current manic episode as diagnosed by DSM-5
* Current active psychotic symptoms
* Presence of active suicidal risk as indicated by a score of 2 or more on item 12 (i.e. frequent thought and/or plans to end their life) of the QIDS (Rush et al., 2003) confirmed by convergent clinical opinion.
* Taking part in concurrent treatment studies investigating pharmacological or psychological treatment for BD.

Primary outcomes:
measure: Change from baseline Mood variability to follow up at 16 weeks after end of intervention
timeFrame: The ALS-18 is administered at T0, after 4 weeks baseline at T1, after the end of intervention (12 weeks in the ImCT condition, and 6 weeks in the psychoeducation condition) T2, 8 weeks after the end of intervention T3, and after 16 weeks follow up -T4.
Secondary outcomes:
measure: Change from baseline Level of depression to follow up at to follow up at 16 weeks
timeFrame: measured weekly throughout the duration of the study in both groups (32 weeks imCT and 26 weeks psychoeducation/TAU).
measure: Change from baseline level of mania to follow up at 16 weeks
timeFrame: measured weekly throughout the duration of the study in both groups ( 32 weeks imCT and 26 weekspsychoeducation/TAU).
measure: Change from baseline level of anxiety to follow up at 16 weeks
timeFrame: measured both daily and weekly throughout the duration of the study in both groups (32 weeks imCT and 26 weeks psychoeducation/TAU)
measure: Change from baseline level of hopelessness to follow up at 16 weeks follow up
timeFrame: measured at baseline (T0), after 4 weeks pre-intervention (T1), post-intervention after 6 weeks in the psychoeduc condition and 12 weeks in the ImCT condition (T2) and at follow up at 8 weeks (T3) and at 16 weeks (T4).
measure: Change from baseline level of general functioning and coping to follow up at 16 weeks
timeFrame: Participants rate their level of functioning at baseline (T0), after 4 weeks pre-intervention (T1), post-intervention12 weeks in the ImCT condition and 6 weeks in the psychoeducation condition (T2) and at follow up at 8 weeks (T3) and at 16 weeks (T4).
measure: Change from baseline level of mood variability to follow up at 16 weeks
timeFrame: Daily measurements throughout the duration of the study, 32 weeks for the participants in the ImCT condition and 26 weeks for the participants in the psychoeducation condition
measure: Change from baseline level of anxiety to follow up at 16 weeks
timeFrame: Daily measurements throughout the duration of the study, 32 weeks for the participants in the ImCT condition and 26 weeks for the participants in the psychoeducation condition
Other outcomes:
measure: General Imagery (frequency of imagery, quality of imagery and appraisals of imagery):
timeFrame: administered at T0, after 4 weeks baseline at T1, after the end of intervention (12 weeks in the ImCT condition, and 6 weeks in the psychoeducation condition) T2, 8 weeks after the end of intervention T3, and after 16 weeks follow up -T4.
measure: Ratings of target imagery (moderator)
timeFrame: Measured weekly throughout the study for 32 weeks in the ImCT condition and 26 weeks in the psychoeducation condition
measure: General Imagery
timeFrame: administered at T0, after 4 weeks baseline at T1, after the end of intervention (12 weeks in the ImCT condition, and 6 weeks in the psychoeducation condition) T2, 8 weeks after the end of intervention T3, and after 16 weeks follow up -T4.
Locations:
city: Eindhoven
country: Netherlands
facility: Centrum Bipolair, GGzE
Study officials:
affiliation: Maastricht University
name: karin van den Berg
role: PRINCIPAL_INVESTIGATOR
References: