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Can Imagination Change Upsetting Memories of Trauma?

Primary Purpose

Psychosis

Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Imagery Rescripting
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring Imagery rescripting, case series, ImRs, Psychosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • South London and the Maudsley NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Waiting Pre-Intervention Control

Imagery Rescripting

Arm Description

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

3 Sessions of Imagery Rescripting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Psychotic Symptom Rating Scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher, 1999)
The PSYRATS was developed to measure dimensions of delusional beliefs (6 item Delusions Scale) and auditory hallucinations (11 item Auditory Hallucination Scale). The six items on the auditory hallucination sub-scale consists of items such as negative content, frequency, loudness, intensity and amount of distress and degree of disruption and control. The six-item delusion subscale consists of items such as duration and amount of pre-occupation, intensity and amount of distress and disruption, and degree of conviction. All items are rated on a five-point scale of increasing severity (0= No problem to 4 = Maximum severity). The PSYRATS has been shown to have good validity and reliability, with sensitivity to change (Haddock et al., 1999). This study will use the PSYRATS to describe the study sample.
Change in Wellbeing through 'The Warwick-Edinburgh Mental Well-being Scale' (WEMWBS; Tennant et al, 2007)
The WEMWBS assessed wellbeing on 14 items rated on a 5-point Likert scale, ranging from "none of the time" to "all of the time". A total score ranging from 14-70 is calculated. Higher scores indicate higher levels of mental wellbeing. WEWBS shows high reliability, low social desirability, and confirmatory factor analysis supported the single-factor hypothesis (Tennant et al., 2007). It also shows high correlations with other well-being scales and low to moderate positive correlation with overall health (Tennant et al., 2007).
Change in PTSD symptoms through 'The Posttraumatic Diagnostic Scale for DSM-5' (PDS-5; Foa et al., 2016)
a 49-item self-report measure including all DSM-IV symptom criteria. 20 of these items asks participants to rate symptoms, and two questions relate to distress and interference. It has high face validity, internal consistency and reliability (Foa et al., 2016). This study will use the symptom section assessed over the past week, in order to measure change over time.
Mini-Trauma and Life Events Checklist (mini-TALE; Hardy et al, in prep)
a brief measure of trauma history, focusing on victimisation events with a general probe for other significant events experienced. It includes 5 items, each rated for occurrence, frequency, and age of occurrence.
Semi-Structured interview (adapted from Hackmann, Clark ,& McManus's (2000) work on social phobia)
adapted from Hackmann, Clark, & McManus's (2000) work on social phobia, also used in Ison et al. (2014). This consists of a series of standardised questions asking clients to identify an index intrusive traumatic memory. The dimensions of this index memory will be assessed during the interview, including; the associated negative appraisal, intrusion frequency, associated distress and control over the memory. A visual analogue scale ranging from 0 to 10 will be used.
Credibility and Expectancy Questionnaire (CEQ; Borkovec & Nau, 1972)
item self-report instrument that measures treatment credibility, and client expectancy for improvement. The CEQ has high internal consistency (a = 0.79-0.90). Retest reliability is r = 0.82 for the expectancy factor and r = 0.75 for the credibility factor (Devilly & Borkovec, 2000). The first four items are rated based on cognitive appraisal of the treatment (e.g. At this point, how successfully do you think this treatment will be in reducing your symptoms?), whereas the last two items are rated based on feelings about the treatment. To reduce demand characteristics, client forms will be sealed in an envelope upon completion, and clients will be told that the therapist will only see the forms after they have finished participation.
Client Satisfaction Questionnaire (CSQ-8; Larsen et al, 1979)
an eight-item version, to evaluate patient satisfaction. The sum of the responses to the CSQ-8 ranges from 8 to 32, with higher scores indicating greater satisfaction. The CSQ-8 has demonstrated high internal consistency across a large number of studies (Attkisson & Greenfield, 1999).

Full Information

First Posted
July 11, 2018
Last Updated
July 23, 2018
Sponsor
King's College London
Collaborators
South London and the Maudsley NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03607630
Brief Title
Can Imagination Change Upsetting Memories of Trauma?
Official Title
Can Imagination Change Upsetting Memories of Trauma?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 3, 2018 (Anticipated)
Primary Completion Date
February 28, 2019 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
South London and the Maudsley NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
Imagery rescripting, case series, ImRs, Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Multiple Baseline Case Series - randomization for how long participants wait pre-intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Waiting Pre-Intervention Control
Arm Type
No Intervention
Arm Description
Participant completes measures for 1-3 weeks (randomly chosen) before they complete the intervention. Participants act as their own controls
Arm Title
Imagery Rescripting
Arm Type
Experimental
Arm Description
3 Sessions of Imagery Rescripting
Intervention Type
Other
Intervention Name(s)
Imagery Rescripting
Intervention Description
psychological therapy
Primary Outcome Measure Information:
Title
Daily Ratings measuring change in Index Memory throughout the project
Description
Change in participant's conviction in the distressing appraisal, frequency, distress, and sense of control associated with the memory
Time Frame
Daily throughout the project, up to 8 weeks
Secondary Outcome Measure Information:
Title
Psychotic Symptom Rating Scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher, 1999)
Description
The PSYRATS was developed to measure dimensions of delusional beliefs (6 item Delusions Scale) and auditory hallucinations (11 item Auditory Hallucination Scale). The six items on the auditory hallucination sub-scale consists of items such as negative content, frequency, loudness, intensity and amount of distress and degree of disruption and control. The six-item delusion subscale consists of items such as duration and amount of pre-occupation, intensity and amount of distress and disruption, and degree of conviction. All items are rated on a five-point scale of increasing severity (0= No problem to 4 = Maximum severity). The PSYRATS has been shown to have good validity and reliability, with sensitivity to change (Haddock et al., 1999). This study will use the PSYRATS to describe the study sample.
Time Frame
First week at the initial assessment
Title
Change in Wellbeing through 'The Warwick-Edinburgh Mental Well-being Scale' (WEMWBS; Tennant et al, 2007)
Description
The WEMWBS assessed wellbeing on 14 items rated on a 5-point Likert scale, ranging from "none of the time" to "all of the time". A total score ranging from 14-70 is calculated. Higher scores indicate higher levels of mental wellbeing. WEWBS shows high reliability, low social desirability, and confirmatory factor analysis supported the single-factor hypothesis (Tennant et al., 2007). It also shows high correlations with other well-being scales and low to moderate positive correlation with overall health (Tennant et al., 2007).
Time Frame
First week at Initial assessment and 1 week post therapy
Title
Change in PTSD symptoms through 'The Posttraumatic Diagnostic Scale for DSM-5' (PDS-5; Foa et al., 2016)
Description
a 49-item self-report measure including all DSM-IV symptom criteria. 20 of these items asks participants to rate symptoms, and two questions relate to distress and interference. It has high face validity, internal consistency and reliability (Foa et al., 2016). This study will use the symptom section assessed over the past week, in order to measure change over time.
Time Frame
First week at Initial assessment and 1 week post therapy
Title
Mini-Trauma and Life Events Checklist (mini-TALE; Hardy et al, in prep)
Description
a brief measure of trauma history, focusing on victimisation events with a general probe for other significant events experienced. It includes 5 items, each rated for occurrence, frequency, and age of occurrence.
Time Frame
First week at Initial Assessment
Title
Semi-Structured interview (adapted from Hackmann, Clark ,& McManus's (2000) work on social phobia)
Description
adapted from Hackmann, Clark, & McManus's (2000) work on social phobia, also used in Ison et al. (2014). This consists of a series of standardised questions asking clients to identify an index intrusive traumatic memory. The dimensions of this index memory will be assessed during the interview, including; the associated negative appraisal, intrusion frequency, associated distress and control over the memory. A visual analogue scale ranging from 0 to 10 will be used.
Time Frame
First Week at Initial Assessment
Title
Credibility and Expectancy Questionnaire (CEQ; Borkovec & Nau, 1972)
Description
item self-report instrument that measures treatment credibility, and client expectancy for improvement. The CEQ has high internal consistency (a = 0.79-0.90). Retest reliability is r = 0.82 for the expectancy factor and r = 0.75 for the credibility factor (Devilly & Borkovec, 2000). The first four items are rated based on cognitive appraisal of the treatment (e.g. At this point, how successfully do you think this treatment will be in reducing your symptoms?), whereas the last two items are rated based on feelings about the treatment. To reduce demand characteristics, client forms will be sealed in an envelope upon completion, and clients will be told that the therapist will only see the forms after they have finished participation.
Time Frame
First session of therapy, this may be at week 2, 3 or 4, depending upon baseline waitlist time
Title
Client Satisfaction Questionnaire (CSQ-8; Larsen et al, 1979)
Description
an eight-item version, to evaluate patient satisfaction. The sum of the responses to the CSQ-8 ranges from 8 to 32, with higher scores indicating greater satisfaction. The CSQ-8 has demonstrated high internal consistency across a large number of studies (Attkisson & Greenfield, 1999).
Time Frame
One week Post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel J Clarke
Phone
07486854611
Email
rachel.clarke@kcl.ac.uk
Facility Information:
Facility Name
South London and the Maudsley NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Liebscher
Phone
02078480251
Email
jennifer.liebscher@kcl.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

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Can Imagination Change Upsetting Memories of Trauma?

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