Condition category
Mental and Behavioural Disorders
Date applied
08/10/2018
Date assigned
16/10/2018
Last edited
19/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Protocol

Plain English Summary

Background and study aims
Bipolar disorder (BD), formerly known as manic depression, is associated with episodes of extreme high and low mood. Relapse rates are high and there is considerable room for improvement in the treatment of BD. People diagnosed with BD tend to suffer from anxiety. Being anxious is linked to people being more likely to have extreme mood swings and to attempt suicide. However, there are no treatments for anxiety for people in this group. Researchers have been working on developing a new treatment for people diagnosed with BD and have discovered that the anxiety they experience is driven by having lots of emotional mental images that keep popping into their minds. On the back of this work, and together with service users diagnosed with BD, a new intervention has been developed called Imagery Based Emotion Regulation. It involves training people in skills to better manage their distressing mental images. An early version of this intervention was adapted based on feedback from those who received it and input from service-user focus groups. Imagery Based Emotion Regulation (IBER) involves up to 12 sessions within 4 months. It has been tested with 14 patients diagnosed with BD and has been found to reduce anxiety and improve mood stability. Patients reported that they found the skills easy to use. A full trial is planned to see whether IBER really works and is value for money. First, a smaller study needs to be conducted to check that a big study would be acceptable to patients and achievable within the planned time limits.

Who can participate?
People aged 18 or over with BD

What does the study involve?
Participants are randomly allocated to be offered IBER or to receive routine NHS care. IBER is delivered over 12 one-hour individual sessions to be completed within 4 months. Sessions are normally weekly, moving to fortnightly at session 8 (allowing flexibility for therapist and patient illness or annual leave). IBER involves training individuals to be able to modify and regulate their emotional reactions to intrusive mental images. Assessments are carried out over 8 months to help to decide if a big trial should be done.

What are the possible benefits and risks of participating?
Many patients have a positive experience of the research assessments conducted within ‘treatment as usual’, and this can provide important information for the NHS clinical team (e.g. previously unnoticed levels of depression and anxiety). Those who are allocated to receive IBER may become anxious as to what is involved. This will be dealt with during the random allocation outcome meeting and the first session of treatment, led by experienced clinicians.

Where is the study run from?
1. Berkshire Healthcare NHS Foundation Trust (UK)
2. Devon Partnership NHS Trust (UK)

When is the study starting and how long is it expected to run for?
September 2018 to November 2020

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Prof. Craig Steel
craig.steel@hmc.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Craig Steel

ORCID ID

http://orcid.org/0000-0002-1643-516X

Contact details

School of Psychology and Clinical Language Sciences
University of Reading
Reading
RG6 6AL
United Kingdom
+44 (0)118 378 7550
craig.steel@hmc.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

37141; PB-PG-1216-20009

Study information

Scientific title

Imagery Based Emotion Regulation (IBER) for bipolar disorder: a feasibility study

Acronym

IBER

Study hypothesis

The feasibility study will inform the recruitment and timeline of a full trial by establishing the number of participants identified, approached, consented and randomised within a fixed period along with the participant retention rates for followup assessment and completion of intervention.

Ethics approval

Berkshire B REC, 02/05/2018, ref: 18/SC/0164

Study design

Randomised; Interventional; Design type: Treatment, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Bipolar disorder

Intervention

Participants are randomised 1:1 stratified by site to either:
1. Imagery Based Emotion Regulation (IBER)
2. Standard NHS treatment as control

IBER is a structured intervention delivered via 12 one hour individual sessions to be completed within 4 months. Sessions are normally weekly, moving to fortnightly at session 8 (allowing flexibility for therapist and patient illness or annual leave). IBER involves training individuals to be able to modify and regulate their emotional reactions to intrusive mental images, and is comprised of three stages:

Assessment: The assessment of current coping strategies and, where necessary, the development of a crises management plan. The therapist then assesses the occurrence of intrusive mental images, including how many different images occur, how often and with what emotional impact. A personalised treatment plan is then developed, in which the most significantly distressing images are identified for treatment.

Treatment: Four distinct theoretically informed modules have been developed as outlined below. Each distressing image is treated through training the patient in one or more of the following four techniques and strategies:
1. Imagery Rescripting (IR)
2. Visual Imagery Techniques (VIT)
3. Positive Imagery
4. Competing Tasks

Consolidation: A review of what has been achieved during the intervention, including the participant making a video blueprint for use in the future.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Recruitment measured by number of referrals and number consenting and randomised; Timepoint: Baseline
2. Retention measured by percentage follow-up and questionnaire response rates; Timepoint(s): 4 and 8 months assessment points

Progression to a full trial will be based on the following criteria:
1. No serious negative consequences are associated with trial participation (criterion 1)
2. Any concerns over the feasibility and acceptability of a full trial can be rectified (criterion 2)
3. Overall recruitment at 80% or above within the 12-month recruitment period (criterion 3)
4. 8-month follow up data is obtained from at least 80% of participants (criterion 4)
5. At least 80% of participants allocated to the intervention group do not drop out (i.e. attend at least 50% of the possible sessions) (criterion 5)

Secondary outcome measures

1. Attendance at intervention sessions; Timepoint: 4 months
2. Qualitative interview exploring the personal experiences of involvement in the trial (including both arms); Timepoint: 4 months

Overall trial start date

10/09/2018

Overall trial end date

10/11/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. DSM-V diagnosis of bipolar disorder (I, II or other specified) assessed using the Structured Clinical Interview for DSM-V (SCID)
2. Aged 16 or above; Updated 31/01/2019: Aged 18 or above
3. Score 5 or above on the Generalised Anxiety Disorder Assessment (GAD7)
4. Sufficient understanding of English in order to be able to engage in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

1. Currently within an episode of depression or mania
2. Unable to provide informed consent
3. Acute suicide risk
4. DSM-V diagnosis of substance use disorder, moderate or severe assessed using SCID
5. A change in medication within 3 months prior to randomisation
6. Currently engaged in a psychological intervention

Recruitment start date

15/09/2018

Recruitment end date

31/01/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Berkshire Healthcare NHS Foundation Trust
Fitzwilliam House Skimped Hill Lane
Bracknell
RG12 1BQ
United Kingdom

Trial participating centre

Devon Partnership NHS Trust
Wonford House Dryden Rd
Exeter
EX2 5AF
United Kingdom

Sponsor information

Organisation

Berkshire Healthcare NHS Foundation Trust

Sponsor details

Skimped Hill Lane
Bracknell
RG12 1BQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: PB-PG-1216-20009

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of the study results in a peer reviewed journal at approximately end of 2020.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Craig Steel (craig.steel@hmc.ox.ac.uk). The data will be mood and health economics questionnaires, and will be available for 5 years from late 2020 onwards. The data will be anonymised and consent will be taken.

Intention to publish date

01/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

2020 protocol in https://pubmed.ncbi.nlm.nih.gov/32549994/ (added 19/06/2020)

Publication citations

Additional files

Editorial Notes

19/06/2020: Publication reference added. 28/11/2019: The recruitment end date was changed from 15/10/2019 to 31/01/2020, contact details updated. 25/03/2019: The condition has been changed from "Specialty: Mental Health, Primary sub-specialty: Bipolar Disorder; Health Category: Mental health; Disease/Condition: Mood [affective] disorders" to "Bipolar disorder" following a request from the NIHR. 20/02/2019: Contact details updated. 31/01/2019: The inclusion criteria were updated.