Imagery based emotion regulation for bipolar disorder
| ISRCTN | ISRCTN16321795 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16321795 |
| Secondary identifying numbers | 37141; PB-PG-1216-20009 |
- Submission date
- 08/10/2018
- Registration date
- 16/10/2018
- Last edited
- 19/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Scientific
School of Psychology and Clinical Language Sciences
University of Reading
Reading
RG6 6AL
United Kingdom
 ORCID ID |
0000-0002-1643-516X |
|---|---|
| Phone | +44 (0)118 378 7550 |
| craig.steel@hmc.ox.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Psychological & Behavioural |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Imagery Based Emotion Regulation (IBER) for bipolar disorder: a feasibility study |
| 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(s) | Berkshire B REC, 02/05/2018, ref: 18/SC/0164 |
| 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 |
| 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 study start date | 10/09/2018 |
| Overall study end date | 10/11/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| 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 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
- England
- United Kingdom
Study participating centres
Skimped Hill Lane
Bracknell
RG12 1BQ
United Kingdom
Dryden Rd
Exeter
EX2 5AF
United Kingdom
Sponsor information
Hospital/treatment centre
Skimped Hill Lane
Bracknell
RG12 1BQ
England
United Kingdom
"ROR" |
https://ror.org/03t542436 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of the study results in a peer reviewed journal at approximately end of 2020. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/06/2020 | 19/06/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
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.
