NCT05042050

Brief Summary

The relationships we have in childhood affect how we relate to others across our life, including how safe or secure we feel. If our caregivers do not meet our needs well enough in childhood, this can lead to an 'insecure attachment style'. This means we may push others away or cling to them, but never feel fully safe or secure with them. This style is common in people who have mental health problems. This includes psychosis, when people have unusual experiences such as hearing voices others cannot hear. A lot of people with psychosis have difficult experiences with mental health services. This includes involuntary treatments, traumatic interactions and hospital stays, where they may think staff are trying to harm rather than help them. As a result they may not feel safe working with staff and they might re-experience the negative memories of these events. This is known as psychosis-related Post-Traumatic Stress Disorder (PR-PTSD) and can lead to ongoing problems. Imagery is often defined as mental pictures but it includes imagining our senses (smell, touch, taste) too. It can be a useful therapy tool to help people to work with difficult memories and can help them to feel more safe and secure. Research shows that this is helpful for people with psychosis and people who have been through trauma. Hence, it may be helpful for people with PR-PTSD. The study aims to see if it is viable to do a 6-session therapy using imagery to target PR-PTSD memories. The study will use a case series design where up to 12 people with psychosis will be able to try the therapy. They will be asked to complete questionnaires to understand any potential benefits of the therapy. The findings could inform the research and allow for further development of therapies in this area.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

April 27, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2022

Completed
Last Updated

November 28, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

August 31, 2021

Last Update Submit

November 24, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Number of participants approached and recruited to the intervention

    Throughout recruitment phase of the study, an average of 24 weeks

  • Number of sessions attended

    Calculated as a percentage

    Throughout the study, attendance recorded for each intervention session, an average of 1 year

  • Number of participants who drop out of the intervention

    Including the point at which they drop out

    For the duration of the study, an average of 1 year

  • Number of Adverse Events and Serious Adverts Events recorded during the study

    For the duration of the study, an average of 1 year

Secondary Outcomes (6)

  • The suitability of outcome measures used, determined by the number completed

    For the duration of the study, an average of 1 year

  • Change from baseline in PTSD score

    For duration of intervention, up to 12 weeks

  • Change from baseline in paranoia score

    For duration of intervention, up to 12 weeks

  • Change from baseline in core schemas

    For duration of intervention, up to 12 weeks

  • Change from baseline in attachment style

    For duration of intervention, up to 12 weeks

  • +1 more secondary outcomes

Study Arms (1)

A-iMAPS Intervention

EXPERIMENTAL

Participants will receive six sessions of Attachment-focused iMAgery therapy for PSychosis. They will be randomised to different baseline lengths (two to five assessment sessions)

Behavioral: A-iMAPS

Interventions

A-iMAPSBEHAVIORAL

Imagery therapy targeting Psychosis-Related PTSD

A-iMAPS Intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Is currently receiving care under an NHS Community Mental Health Team, and meets ICD-10 or ICD-11 criteria for a schizophrenia-spectrum diagnosis (schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder or psychotic disorder not otherwise specified) indicated by case notes, or under the care of an Early Intervention in Psychosis Service
  • Aged 16 or above
  • Medication stable for ≥ one month, as indicated by their Care Coordinator
  • Has capacity to give written, informed consent
  • Proficient in English to complete study questionnaires
  • A score of one or more on the four psychosis-related trauma items (items 15 to 18) on the Trauma and Life Events Checklist (Carr et al., 2018b)

You may not qualify if:

  • Has an acquired brain injury
  • Has a history of substance misuse that is judged to be the acute cause of the psychotic experiences
  • Currently experiencing an acute episode requiring inpatient care
  • Currently undertaking psychological therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennine Care NHS Foundation Trust

Manchester, United Kingdom

Location

Related Publications (9)

  • Mikulincer M, Shaver PR. An attachment perspective on psychopathology. World Psychiatry. 2012 Feb;11(1):11-5. doi: 10.1016/j.wpsyc.2012.01.003.

    PMID: 22294997BACKGROUND
  • Carr SC, Hardy A, Fornells-Ambrojo M. Relationship between attachment style and symptom severity across the psychosis spectrum: A meta-analysis. Clin Psychol Rev. 2018 Feb;59:145-158. doi: 10.1016/j.cpr.2017.12.001. Epub 2017 Dec 6.

    PMID: 29229220BACKGROUND
  • Lavin R, Bucci S, Varese F, Berry K. The relationship between insecure attachment and paranoia in psychosis: A systematic literature review. Br J Clin Psychol. 2020 Mar;59(1):39-65. doi: 10.1111/bjc.12231. Epub 2019 Aug 7.

    PMID: 31390076BACKGROUND
  • Bullock G, Newman-Taylor K, Stopa L. The role of mental imagery in non-clinical paranoia. J Behav Ther Exp Psychiatry. 2016 Mar;50:264-8. doi: 10.1016/j.jbtep.2015.10.002. Epub 2015 Oct 8.

    PMID: 26492591BACKGROUND
  • Pitfield C, Maguire T, Newman-Taylor K. Impact of attachment imagery on paranoia and mood: evidence from two single case studies. Behav Cogn Psychother. 2020 Sep;48(5):572-583. doi: 10.1017/S1352465820000351. Epub 2020 Jun 29.

    PMID: 32594948BACKGROUND
  • Morrison AP. The use of imagery in cognitive therapy for psychosis: a case example. Memory. 2004 Jul;12(4):517-24. doi: 10.1080/09658210444000142.

    PMID: 15487547BACKGROUND
  • Holmes EA, Mathews A, Dalgleish T, Mackintosh B. Positive interpretation training: effects of mental imagery versus verbal training on positive mood. Behav Ther. 2006 Sep;37(3):237-47. doi: 10.1016/j.beth.2006.02.002. Epub 2006 May 24.

    PMID: 16942975BACKGROUND
  • Taylor CDJ, Bee PE, Kelly J, Emsley R, Haddock G. iMAgery focused psychological therapy for persecutory delusions in PSychosis (iMAPS): a multiple baseline experimental case series. Behav Cogn Psychother. 2020 Sep;48(5):530-545. doi: 10.1017/S1352465820000168. Epub 2020 Apr 8.

    PMID: 32264985BACKGROUND
  • Buswell G, Haime Z, Lloyd-Evans B, Billings J. A systematic review of PTSD to the experience of psychosis: prevalence and associated factors. BMC Psychiatry. 2021 Jan 7;21(1):9. doi: 10.1186/s12888-020-02999-x.

    PMID: 33413179BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Katherine Berry, PhD

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Proof of Concept Case Series Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trainee Clinical Psychologist

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 13, 2021

Study Start

April 27, 2022

Primary Completion

November 16, 2022

Study Completion

November 23, 2022

Last Updated

November 28, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Aggregated anonymised participant data

Locations