A brief imagery intervention for future-oriented mental images
| ISRCTN | ISRCTN16326066 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16326066 |
| EudraCT/CTIS number | Nil Known |
| IRAS number | 306129 |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | IRAS 306129 |
- Submission date
- 27/04/2023
- Registration date
- 02/05/2023
- Last edited
- 31/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
It is common for people to feel anxious, suspicious, or threatened. These feelings are often experienced alongside threatening verbal thoughts and/or threatening mental images. Mental images often evoke greater emotional responses compared to verbal thoughts. Treatments targeting specific symptoms can be highly successful, for example, some studies have found that interventions using imagery-based strategies are effective when treating mental images. This study aims to plan to develop a brief imagery-based intervention targeting mental images, which are not related to past life events to reduce the distress that they cause. The study team aims to assess the acceptability of the intervention and to investigate whether it will lead to a reduction in feelings of anxiety, suspiciousness, and threat. Results from this study will determine whether or not this new treatment seems promising, and whether further studies are justified.
Who can participate?
Adults who have experienced distress through hearing voices and/or paranoia, and who also experience distressing mental images
What does the study involve?
Participation will involve completing an assessment interview either via Microsoft Teams or telephone. This session will involve discussing the aims of the intervention and completing baseline questionnaires. The questionnaires will ask you about your experiences of mood, general anxiety, thoughts of suspiciousness and threat, and mental images. The mental images will be briefly discussed and participants will be provided with an overview of the intervention.
Following this, participants will begin the brief imagery-based intervention, which will consist of four hourly sessions with the project lead, a trainee clinical psychologist who has received training in this approach. The first session will consist of providing participants with an understanding of what distressing mental images are and why imagery-based techniques are helpful when working with distressing mental images. Then an image to work on will be identified and a brief questionnaire will be completed.
In the second session, the details of your chosen mental image will be mapped out to better understand what has maintained it. You will again be asked to complete a brief questionnaire.
In the third session, the participant will start practising various techniques to increase the control of their mental images and complete a brief questionnaire.
In the fourth session, the learning will be summarised and there will be time to think about how the techniques can be applied to other distressing mental images that you may have, as well as complete a brief questionnaire. The participant will be invited back a week later to complete a follow-up interview where they will be asked to share feedback on their experience of completing the intervention. They will also be asked to repeat the baseline questionnaires which were completed at the initial assessment session. It is a good clinical practice to record sessions, which the trainee clinical psychologist will be able to share and discuss in supervision. Supervision will take place on a weekly basis and all recordings will be permanently deleted once they have been discussed. Recordings will not be transcribed. It can be specified on the consent form, whether participants consent to this or not. The trainee clinical psychologist will take notes throughout their participation.
What are the possible benefits and risks of participating?
It is hoped that participation will help reduce the experience of distressing mental images. It is also hoped that the findings will inform a larger-scale study that will eventually contribute to NHS services using the intervention in treating distressing mental images. Some of the questionnaire measures and content of the sessions may evoke difficult emotions. Participants will be provided with contact details of services and third-party organisations that will be able to offer support and guidance if they experience further distress. They can withdraw from the study at any point. If the capacity to consent is lost during the study, identifiable data will be retained.
Where is the study run from?
This study is being conducted as part of the project lead, Nithura Sivarajah’s, PhD thesis, University of Oxford (UK)
When is the study starting and how long is it expected to run from?
February 2021 to March 2023
Who is funding the study?
The University of Oxford Clinical Psychology Doctorate Programme (UK)
Who is the main contact?
Nithura Sivarajah, nithura.sivarajah@oxfordhealth.nhs.uk (UK)
Contact information
Scientific
Oxford Institute of Clinical Psychology Training and Research Isis Education Centre
Warneford Hospital
Headington
Oxford
OX3 7JX
United Kingdom
 ORCID ID |
0000-0002-6824-1551 |
|---|---|
| Phone | None available |
| nithura.sivarajah@hmc.ox.ac.uk |
Public
Oxford Institute of Clinical Psychology Training and Research Isis Education Centre
Warneford Hospital
Headington
Oxford
OX3 7JX
United Kingdom
| Phone | None available |
|---|---|
| nithura.sivarajah@hmc.ox.ac.uk |
Principal Investigator
Oxford Institute of Clinical Psychology Training and Research Isis Education Centre
Warneford Hospital
Headington
Oxford
OX3 7JX
United Kingdom
| Phone | None available |
|---|---|
| Craig.Steel@hmc.ox.ac.uk |
Study information
| Study design | Mixed methods fixed-baseline case-series design non-controlled non-randomized single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Brief imagery-based metacognitive intervention for flashforwards in psychosis: a fixed baseline case series |
| Study acronym | IBMI FOR FLASHFORWARDS |
| Study hypothesis | The intervention would: 1. Be acceptable and feasible to deliver 2. Lead to improvements in measures of mental imagery characteristics (vividness, conviction, control, distress, and frequency), anxiety, depression, persecutory delusions, and schema beliefs 3. Change will be maintained at a one-week follow-up |
| Ethics approval(s) | Approved 08/12/2022, North of Scotland Research Ethics Service (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK; +44 (0)1224558458; gram.nosres@nhs.scot), ref: 22/NS/0084 |
| Condition | Persecutory delusions in psychosis |
| Intervention | A novel four-session imagery-based metacognitive intervention was developed as part of the study. All participants received the intervention. All sessions will be delivered online via Microsoft Teams and all questionnaires and forms will be completed using Microsoft Forms. Supervision sessions were also delivered via Microsoft Teams. All recruitment and research sessions took place via Microsoft Teams. An overview of the metacognitive intervention: Session 1: Psychoeducation and Identifying Target Flashforward delivered by final year trainee clinical psychologist (also qualified High-Intensity CBT therapist), Nithura Sivarajah and supervised by Craig Steel 1. Discuss verbal thoughts versus mental imagery in relation to emotions. 2. Discuss brain activity and findings from neuroimaging studies. 3. The brain cannot tell the difference between imagined events and real events – which explains the strong emotional reactions. 4. Use examples to explain the difficulties and power of mental images versus real situations. This could include participants hearing real music versus imagining hearing music, participants seeing specific facial expressions such as an angry face versus imagining seeing an angry face and imagining taking a penalty versus taking a penalty. 5. Explain that control over images can impact distress caused by the images. 6. Using positive images to evoke happy and safe feelings. 7. You can learn to change images, and the brain will react as if it is happening, even if it’s not real, and the mood can change. 8. Identify target flashforward 9. Complete the Mental Imagery in Psychosis Questionnaire (MIPQ) Session 2: Microformulation delivered by Nithura Sivarajah and supervised by Craig Steel 1. Discuss the central role of control. 2. Complete microformulation 3. Complete MIPQ Session 3: Metacognitive Techniques delivered by Nithura Sivarajah and supervised by Craig Steel 1. Examples of attention techniques Attention training Switching techniques 2. Examples of imagery manipulation techniques Imagining popping the image like a balloon Imagining smashing the image like glass Imagining shrinking the image or blowing it up Imagining the image on a TV and switching channels Imagining the image being on the radio and turning down the volume/switching it off Imagining changing the colour of the image Imagining the image looking funny Imagining putting the image in a bottle and throwing it into the sea Session 4: Ending delivered by Nithura Sivarajah and supervised by Craig Steel 1. Recall/summarise and reflect on the learning. 2. Plan how to continue to implement the techniques in the future and explore how to widen their application (e.g., how to use them for other mental images). Follow Up: Delivered by Nithura Sivarajah and supervised by Craig Steel 1. Complete the qualitative feedback survey 2. Repeat baseline questionnaires 3. Complete MIPQ |
| Intervention type | Behavioural |
| Primary outcome measure | Acceptability and feasibility measured by attendance rates of the sessions in the case series. A Microsoft Teams grid was created to note down attendance after each session, and safety in relation to experiences of adverse events. A record was kept on any reported experiences of any risk to self, to or from others, e.g., episodes of deliberate self-harm, hospitalizations, losses, relapses or any other traumatic experiences, measured through verbal feedback and qualitative feedback measured at the final session, the follow-up session, using a bespoke qualitative measure. |
| Secondary outcome measures | 1. Reliable change index and clinical statistical change measured using scoring from the following scales at assessment (baseline) and follow-up: 1.1. Generalised Anxiety Disorder Assessment (GAD-7) 1.2. Patient Health Questionnaire-9 (PHQ-9) 1.3. The Persecutory and Deservedness Scale (PaDS) 1.4. Brief Core Schema Scale (BCSS) 2. Imagery characteristics measured using an adapted Mental Imagery in Psychosis Questionnaire (MIPQ), participants rated MIPQ scores at every session. These were evaluated using visual analysis and Tau-U calculator. |
| Overall study start date | 25/02/2021 |
| Overall study end date | 31/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 8-9 |
| Total final enrolment | 8 |
| Participant inclusion criteria | 1. Aged 18-65 years old 2. Primary reported experiences of psychosis supplemented by diagnostic criteria for schizophrenia and schizoaffective disorder from the ICD-11 3. Identifys a distressing flashforward image related to a persecutory delusion 4. Has sufficient understanding of the English language 5. Has the capacity to give consent |
| Participant exclusion criteria | 1. Signs and diagnosis of learning disabilities 2. Endorsement of suicidal intent 3. Current alcohol or substance dependence 4. Documented or suspected neurological or general medical condition that might be responsible for the psychotic manifestation. |
| Recruitment start date | 15/12/2022 |
| Recruitment end date | 17/02/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Slade Site, Horspath Driftway
Headington
Oxford
OX3 7JH
United Kingdom
Honey End Lane
Reading
RG30 4EJ
United Kingdom
Sponsor information
Hospital/treatment centre
Littlemore Mental Health Centre
Sandford Road
Littlemore
Oxford
OX4 4XN
England
United Kingdom
| Phone | +44 (0)1865 901 000 |
|---|---|
| Natalia.Jastrzebska@oxfordhealth.nhs.uk | |
| Website | http://www.oxfordhealth.nhs.uk/ |
"ROR" |
https://ror.org/04c8bjx39 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 30/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Published as a supplement to the results publication |
| Publication and dissemination plan | The study will be submitted as a partial fulfilment of Nithura Sivarajah's thesis for the Doctorate in Clinical Psychology Programme at the University of Oxford. It is also planned the study will be published in a peer-reviewed psychology journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. All information and data will be stored on a password-protected Oxford Health NHS Foundation Trust laptop. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 31/05/2023 | No | No | ||
| HRA research summary | 26/07/2023 | No | No |
Additional files
Editorial Notes
31/05/2023: The basic results have been uploaded to the study outputs table
26/05/2023: Internal review.
02/05/2023: Trial's existence confirmed by NHS Grampian (UK).
