Evaluating the Effectiveness of Imagery Focussed Therapy

Maastricht University

Status: Completed

Conditions: Bipolar Disorder

Treatments: Other: TAU; Other: imagery-focused Cognitive Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03750305

IMCT in BD

Details and patient eligibility

About

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.

Full 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).

Enrollment: 62 patients

Sex: All

Ages: 18 to 68 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

62 participants in 2 patient groups

psychoeducation/TAU

Active Comparator group

Description:

TAU consists of psycho-education for a period of 12 weeks, consisting of 6 2-hour sessions. Psycho-education is offered in groups,

Treatment:

Other: TAU

imCT intervention

Experimental group

Description:

For a period of 12 weeks, 12 1-hour sessions of imagery-focused Cognitive Therapy delivered weekly by a trained therapists, divided in an in depth identification (4 sessions) of images followed by imagery interventions, (6 sessions) and a consolidation phase (2 sessions).

Treatment:

Other: imagery-focused Cognitive Therapy