NCT03607630

Brief Summary

Research suggests that imagination is a powerful tool to change images inside our heads (e.g. memories) and make them less upsetting. It is thought that this occurs through changing the meaning attached to the memory (e.g. I am weak), therefore making it less upsetting to remember. Research has also linked some people's experience of psychosis to distressing trauma memories. Despite this, little is known about whether using imagination to change memories is helpful for people with psychosis. This project will look at whether a talking therapy that uses imagination to change trauma memories helps people with psychosis. This project will specifically look at whether this therapy helps; change the meaning linked to memory, make the memory less upsetting and frequent, and increase sense of control over the memory. This project will recruit six to twelve people with psychosis. Participants will be recruited from services within South London and the Maudsley NHS Foundation Trust's Psychosis Clinical Academic Group. Participants will first be interviewed about their posttraumatic stress difficulties, experiences of psychosis, mental health, and wellbeing. In this appointment, participants will also identify a traumatic memory to focus on during the talking therapy. Four questions about the trauma memory will be asked every day for the remainder of the project. Participants will then wait between one to three weeks before they receive three therapy sessions. Comparing participants to themselves for different periods of time makes sure that their memories do not become less upsetting over time, without therapy. After therapy, participants will continue daily measures for two weeks, with an appointment in the middle (i.e. one week post therapy). This appointment will include questions about posttraumatic stress difficulties, wellbeing and satisfaction with therapy. Participation will last between 6-8 weeks. Participants will be reimbursed for their time

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

July 11, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

August 3, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

July 31, 2018

Status Verified

June 1, 2018

Enrollment Period

7 months

First QC Date

July 11, 2018

Last Update Submit

July 23, 2018

Conditions

Keywords

Imagery rescriptingcase seriesImRsPsychosis

Outcome Measures

Primary Outcomes (1)

  • Daily Ratings measuring change in Index Memory throughout the project

    Change in participant's conviction in the distressing appraisal, frequency, distress, and sense of control associated with the memory

    Daily throughout the project, up to 8 weeks

Secondary Outcomes (7)

  • Psychotic Symptom Rating Scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher, 1999)

    First week at the initial assessment

  • Change in Wellbeing through 'The Warwick-Edinburgh Mental Well-being Scale' (WEMWBS; Tennant et al, 2007)

    First week at Initial assessment and 1 week post therapy

  • Change in PTSD symptoms through 'The Posttraumatic Diagnostic Scale for DSM-5' (PDS-5; Foa et al., 2016)

    First week at Initial assessment and 1 week post therapy

  • Mini-Trauma and Life Events Checklist (mini-TALE; Hardy et al, in prep)

    First week at Initial Assessment

  • Semi-Structured interview (adapted from Hackmann, Clark ,& McManus's (2000) work on social phobia)

    First Week at Initial Assessment

  • +2 more secondary outcomes

Study Arms (2)

Waiting Pre-Intervention Control

NO INTERVENTION

Participant completes measures for 1-3 weeks (randomly chosen) before they complete the intervention. Participants act as their own controls

Imagery Rescripting

EXPERIMENTAL

3 Sessions of Imagery Rescripting

Other: Imagery Rescripting

Interventions

psychological therapy

Imagery Rescripting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of a Schizophrenia-spectrum disorder or mood disorder with psychotic features
  • Able to identify an intrusive traumatic memory occurring at least twice in the past week, as assessed by the Post Traumatic Stress Diagnostic Scale.
  • Sufficient English to participate in the project

You may not qualify if:

  • Concurrent trauma-focused psychological therapy
  • Primary diagnosis of learning disability, substance use or organic disorder
  • Acute suicide risk
  • Lack of capacity to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South London and the Maudsley NHS Foundation Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Multiple Baseline Case Series - randomization for how long participants wait pre-intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 31, 2018

Study Start

August 3, 2018

Primary Completion

February 28, 2019

Study Completion

June 1, 2020

Last Updated

July 31, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Participant data will be anonymised. Participant data will only be linked with their participating documents with the research participant. This data will not be shared.

Locations