PsychosisPhase 1/2NCT03607630
Can Imagination Change Upsetting Memories of Trauma?
A Phase 1/2 study testing Imagery Rescripting in people with Psychosis, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis
- What is being tested?
- Imagery Rescripting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Aug 2018to 1 Jun 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
South London and the Maudsley NHS Foundation Trust
London
Jennifer Liebscher, 02078480251, jennifer.liebscher@kcl.ac.uk
About this study
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.
Read more
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
- Conditions
- Psychosis
- Being tested
- Imagery Rescripting
- Keywords
- Imagery rescripting, case series, ImRs, Psychosis
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagery RescriptingOther
psychological therapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Imagery Rescripting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Daily throughout the project, up to 8 weeks
Secondary outcomes (7)
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.
Measured: First week at the initial assessment
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).
Measured: 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)
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.
Measured: First week at Initial assessment and 1 week post therapy
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.
Measured: First week at Initial Assessment
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.
Measured: First Week at Initial Assessment
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.
Measured: First session of therapy, this may be at week 2, 3 or 4, depending upon baseline waitlist time
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).
Measured: One week Post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start3 Aug 2018 (estimated)
- Primary completion28 Feb 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multiple Baseline Case Series - randomization for how long participants wait pre-intervention
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607630
- Sponsor's protocol ID
- 18/LO/0684
- Status last verified
- Jun 2018
- First submitted
- 11 Jul 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Imagination Change Upsetting Memories of Trauma?
- ClinicalTrials.gov ID
- NCT03607630
- Acronym / sponsor ID
- 18/LO/0684
- Conditions
- Psychosis
- Keywords
- Imagery rescripting, case series, ImRs, Psychosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 3 Aug 2018 (estimated)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multiple Baseline Case Series - randomization for how long participants wait pre-intervention
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Imagery Rescripting3 Sessions of Imagery Rescripting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imagery Rescriptingpsychological therapy | Other | Imagery Rescripting |
Primary outcome
Daily Ratings measuring change in Index Memory throughout the project
Time frame: Daily throughout the project, up to 8 weeks
Change in participant's conviction in the distressing appraisal, frequency, distress, and sense of control associated with the memory
7 secondary outcomes
Psychotic Symptom Rating Scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher, 1999)
Time frame: First week at the initial assessment
Change in Wellbeing through 'The Warwick-Edinburgh Mental Well-being Scale' (WEMWBS; Tennant et al, 2007)
Time frame: 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)
Time frame: First week at Initial assessment and 1 week post therapy
Mini-Trauma and Life Events Checklist (mini-TALE; Hardy et al, in prep)
Time frame: First week at Initial Assessment
Semi-Structured interview (adapted from Hackmann, Clark ,& McManus's (2000) work on social phobia)
Time frame: First Week at Initial Assessment
Credibility and Expectancy Questionnaire (CEQ; Borkovec & Nau, 1972)
Time frame: First session of therapy, this may be at week 2, 3 or 4, depending upon baseline waitlist time
Client Satisfaction Questionnaire (CSQ-8; Larsen et al, 1979)
Time frame: One week Post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Imagery Rescripting in people with Psychosis, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel J Clarke (07486854611, rachel.clarke@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Ratings measuring change in Index Memory throughout the project (time frame: Daily throughout the project, up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.