Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539780
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Imagery Rescripting as a Treatment for Early Psychosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Imagery Rescripting for Early Psychosis a Multiple-Baseline Single-Case Experimental Design
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this multiple baseline case series study is to test the effect of imagery rescripting ImRs in early psychosis
Primary objective The course of schema or core beliefs wellbeing and self-esteem in early psychosis
Secondary objective The change in psychotic and trauma symptoms full questionnaire core emotions strength of affect and obtrusiveness of image
Other objectives are research into the working mechanisms of imagery rescripting by collecting qualitative data from patients and their practitioner in a qualitative interview
For this study a multiple-baseline single-case experimental design SCED is used testing different outcome variables in 8 patients with early psychosis After a variable baseline period of 1-3 weeks participants will start twice weekly with imagery rescripting for 4-6 sessions followed by a 3 week follow up
Participants will rate schema- or core beliefs on a visual analogue scale Wellbeing and selfesteem will be measured 4 times with questionnaires In addition Secondary we will asses four times questionnaires about psychotic and trauma symptoms and daily measures of core emotions affect and obtrusiveness of the intrusion After treatment participants will be interviewed about their experiences
Primary objective The course of schema or core beliefs wellbeing and self-esteem in early psychosis
Secondary objective The change in psychotic and trauma symptoms full questionnaire core emotions strength of affect and obtrusiveness of image
Other objectives are research into the working mechanisms of imagery rescripting by collecting qualitative data from patients and their practitioner in a qualitative interview
For this study a multiple-baseline single-case experimental design SCED is used testing different outcome variables in 8 patients with early psychosis After a variable baseline period of 1-3 weeks participants will start twice weekly with imagery rescripting for 4-6 sessions followed by a 3 week follow up
Participants will rate schema- or core beliefs on a visual analogue scale Wellbeing and selfesteem will be measured 4 times with questionnaires In addition Secondary we will asses four times questionnaires about psychotic and trauma symptoms and daily measures of core emotions affect and obtrusiveness of the intrusion After treatment participants will be interviewed about their experiences
Detailed Description:
In a multiple baseline case series study the effectiveness of Imagery Rescripting ImRs as a treatment for Early Psychosis will be researched 5-10 participants with a diagnosis of psychosis will be randomized to a waiting list with variable length between 1-3 weeks After this participants will enter the ImRs approximately 4-6 sessions given twice-weekly Follow up assessment will take place 3 weeks after ending treatment Primary outcome is schema of core beliefs wellbeing and self esteem operationalized by daily measures with visual analogue scales and questionnaires 4 times like the MHQoL and the RSAS Secondary outcomes are psychotic symptoms PSYRATS and trauma symptoms PCL-5 measured 4 times strength of affect and obtrusiveness of image measured daily with VAS scales
The hypothesis is that the primary outcomes will reduce more during the intervention phase compared to the baseline phase and remain stable or even further improve in the follow-up phase For the secondary outcomes the investigator hypothesized a decrease in psychotic and trauma symptoms and less strength of affect and obtrusiveness of image
The largest effect is expected from pre- to post treatment with a relative stable little change during baseline and follow-up
Results will be analyzed using visual inspection repeated measures ANOVA and multilevel analysis pooling the effects of the individual cases Finally participants will be interviewed post treatment about their experiences during treatment
The hypothesis is that the primary outcomes will reduce more during the intervention phase compared to the baseline phase and remain stable or even further improve in the follow-up phase For the secondary outcomes the investigator hypothesized a decrease in psychotic and trauma symptoms and less strength of affect and obtrusiveness of image
The largest effect is expected from pre- to post treatment with a relative stable little change during baseline and follow-up
Results will be analyzed using visual inspection repeated measures ANOVA and multilevel analysis pooling the effects of the individual cases Finally participants will be interviewed post treatment about their experiences during treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None