Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04927533
Status:
RECRUITING
Last Update Posted:
2023-05-09
First Post:
2021-06-02
Brief Title:
The Ronnie Gardiner Method Effectiveness Study
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Universitair Ziekenhuis Brussel
Study Overview
Official Title:
Improving Cognitive and Emotional Processing in Older Psychiatric Patients the Transdiagnostic Effectiveness of the Ronnie Gardiner Method RGM
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators want to investigate the feasibility and transdiagnostic effectiveness of the Ronnie Gardiner Method RGM in a sample of Flemish psychogeriatric residential patients 60 years old admitted to the Psychiatric Clinic of Alexianen Zorggroep Tienen No control group will be used in this study as every patient in the clinic is entitled to receive treatment The investigators expect to observe significant improvements in the core executive functions core EFs by RGM participation The investigators expect that the more sessions participants follow the larger the effects will be Given the strong connection between executive functions and emotion regulation the investigators anticipate that strengthening the core EFs will in turn contribute to better emotion regulation More specifically the mediating role of core EFs in the relationship between the number of RGM sessions attended and improvement in emotion regulation is investigated Given RGMs previously reported effects on quality of life the investigators also expect to observe improved well-being Additionally the investigators want to examine to what extent positive experiences with RGM and temperament based personality types influence the effectiveness of the RGM training
The RGM training will be organised twice a week for a period of 12 weeks The training sessions will be provided by trained RGM-practitioners in the Psychiatric Clinic of the Alexianen Zorggroep Tienen Each session will last at least 45 minutes Core EFs emotion regulation and well-being are evaluated pre- mid- and post-RGM at 6-week intervals using a number of relevant instruments ie questionnaires and neuropsychological tests At baseline the information and consent forms will be delivered to the patient and exclusion criteria will be checked using the MMSE and the patient file Experiences with RGM training will be evaluated midway and post-intervention by means of a brief questionnaire developed by the research team Personality type questionnaires The Behavioural Inhibition System BISBehavioural Activation System BAS scales and the Effortful Control EC scale which allow us to study whether a particular temperament based personality type is predictive of RGMs success are routinely administered in the psychiatric clinic upon admission
The RGM training will be organised twice a week for a period of 12 weeks The training sessions will be provided by trained RGM-practitioners in the Psychiatric Clinic of the Alexianen Zorggroep Tienen Each session will last at least 45 minutes Core EFs emotion regulation and well-being are evaluated pre- mid- and post-RGM at 6-week intervals using a number of relevant instruments ie questionnaires and neuropsychological tests At baseline the information and consent forms will be delivered to the patient and exclusion criteria will be checked using the MMSE and the patient file Experiences with RGM training will be evaluated midway and post-intervention by means of a brief questionnaire developed by the research team Personality type questionnaires The Behavioural Inhibition System BISBehavioural Activation System BAS scales and the Effortful Control EC scale which allow us to study whether a particular temperament based personality type is predictive of RGMs success are routinely administered in the psychiatric clinic upon admission
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None