Evaluating the Effectiveness of Imagery Focussed Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of Cognitive Behavioral Therapy for Treating Depression in People With Bipolar I Disorder

NCT00595387

Bipolar Disorder Depression

COMPLETED NA

Seeing the Light: Early Intervention in People at Risk for Bipolar Disorder

NCT06282250

Bipolar Disorder Mood Swing Prodromal Symptoms

RECRUITING NA

Incorporating Positive Affect Promoting Activities Into Cognitive Behavioral Therapies

NCT06432959

Depression Borderline Personality Disorder Emotion Regulation

COMPLETED NA

Mindfulness Based Cognitive Therapy for Recurrent Depression

NCT01038765

Depressive Disorder, Major

COMPLETED NA

Interpersonal and Social Rhythm Therapy for Adolescents With Bipolar Disorder

NCT00576355

Bipolar Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Between groups, comparing Imagery-Focussed therapy with psychoeducation/TAU/within group, comparing baseline phase with treatment phase.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

psychoeducation/TAU

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

Group Type ACTIVE_COMPARATOR

TAU

Intervention Type OTHER

Psycho-education is offered in groups, using the format described by Honig (Postma, Honig, \& van Gent, 2008).

imCT intervention

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).

Group Type EXPERIMENTAL

imagery-focused Cognitive Therapy

Intervention Type OTHER

In depth identification phase: Therapists and patient collaboratively map out difficulties and pinpoint a treatment focus.

Imagery interventions: The imagery intervention consists of metacognitive imagery rescripting or promoting positive imagery or competing tasks (or a combination of these).

Consolidation: Consist of fine tuning the strategies, relapse prevention using a video diary.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

imagery-focused Cognitive Therapy

In depth identification phase: Therapists and patient collaboratively map out difficulties and pinpoint a treatment focus.

Imagery interventions: The imagery intervention consists of metacognitive imagery rescripting or promoting positive imagery or competing tasks (or a combination of these).

Consolidation: Consist of fine tuning the strategies, relapse prevention using a video diary.

Intervention Type OTHER

TAU

Psycho-education is offered in groups, using the format described by Honig (Postma, Honig, \& van Gent, 2008).

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ImCT Psychoeducation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No