Evaluating the Effectiveness of Imagery Focussed Therapy

NCT03750305 | Completed

• 1 other identifier: IMCT in BD
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Change from baseline Mood variability to follow up at 16 weeks after end of intervention

  Mood variability is measured using the Affect Lability Score Short Version (ALS-18; Oliver \& Simons, 2004). The ALS-18 is a self-report scale measuring lability in affect and consists of 18 items. Ratings are made on a 4-point scale with a maximum score of 72. Scores range from A= very characteristic of me (4 points), to D= very uncharacteristic of me (1 point).

  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 (7)

• Change from baseline Level of depression to follow up at to follow up at 16 weeks

  measured weekly throughout the duration of the study in both groups (32 weeks imCT and 26 weeks psychoeducation/TAU).

• Change from baseline level of mania to follow up at 16 weeks

  measured weekly throughout the duration of the study in both groups ( 32 weeks imCT and 26 weekspsychoeducation/TAU).

• Change from baseline level of anxiety to follow up at 16 weeks

  measured both daily and weekly throughout the duration of the study in both groups (32 weeks imCT and 26 weeks psychoeducation/TAU)

• Change from baseline level of hopelessness to follow up at 16 weeks follow up

  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).

• Change from baseline level of general functioning and coping to follow up at 16 weeks

  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).

Other Outcomes (3)

• General Imagery (frequency of imagery, quality of imagery and appraisals of imagery):

  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.

• Ratings of target imagery (moderator)

  Measured weekly throughout the study for 32 weeks in the ImCT condition and 26 weeks in the psychoeducation condition

• General Imagery

  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.

Study Arms (2)

psychoeducation/TAU

ACTIVE COMPARATOR

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

Other: TAU

imCT intervention

EXPERIMENTAL

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).

Other: imagery-focused Cognitive Therapy

Interventions

imagery-focused Cognitive Therapy 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.

Also known as: ImCT

imCT intervention

TAU OTHER

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

Also known as: Psychoeducation

psychoeducation/TAU

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (1)

Centrum Bipolair, GGzE

Eindhoven, Netherlands

Location

Related Publications (1)

• van den Berg KC, Hendrickson AT, Hales SA, Voncken M, Keijsers GPJ. Comparing the effectiveness of imagery focussed cognitive therapy to group psychoeducation for patients with bipolar disorder: A randomised trial. J Affect Disord. 2023 Jan 1;320:691-700. doi: 10.1016/j.jad.2022.09.160. Epub 2022 Oct 5.

  PMID: 36206888 DERIVED

Related Links

• Applications of time-series analysis to mood fluctuations in bipolar disorder to promote treatment innovation: a case series
• An investigation of mental imagery in bipolar disorder: Exploring "the mind's eye".
• Evidence-based guidelines for treating bipolar disorder Revised third edition recommendations from the British.
• Mental imagery as an emotional amplifier: application to bipolar disorder

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• karin van den Berg

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist, PhD student Maastricht University

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

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: November 23, 2018
• Study Start: October 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)