Clinical trial NCT04927533: The Ronnie Gardiner Method Effectiveness Study
Official title: Improving Cognitive and Emotional Processing in Older (Psychiatric) Patients: the Transdiagnostic Effectiveness of the Ronnie Gardiner Method (RGM).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychiatric Disorder
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Psychiatric Clinic of Alexianen Zorggroep Tienen
First posted: 2021-06-16
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 (i.e. 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 (BIS)/Behavioural 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.


Eligibility criteria: Inclusion Criteria:

* Psychogeriatric inpatients aged 60+

Exclusion Criteria:

* Checking for moderate to severe cognitive impairments (exclusion criterion) using the Mini-Mental State Examination (MMSE; Folstein, Folstein, \& McHugh, 1975; Dutch version: Kok and Verhey, 2002), following exclusion criterion applies: a score of less than 21 on the MMSE (excluding dementia or other moderate to severe cognitive impairment)
* Not fluent in Dutch
* Having undergone surgery and/or chemotherapy in the last three months.

Primary outcomes:
measure: Change in Emotion Regulation using the Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij & Spinhoven, 2002)
timeFrame: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training
measure: Change in Core EFs (i.e. motor/response inhibition, cognitive flexibility and working memory) using four subtests of the Cambridge Neuropsychological Test Automated Battery (CANTAB® [Cognitive assessment software]).
timeFrame: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training
measure: Change in Core EFs (i.e. cognitive inhibition) using the California Older Adult Stroop Test (COAST)
timeFrame: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training
measure: Monitor mental well-being using the Dutch version of the 14-item Warwick-Edingburgh Mental Well-Being Scale (WEMWBS)
timeFrame: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training
Secondary outcomes:
measure: Defining the temperament based personality type using the Behavioural Inhibition System (BIS)/Behavioural Activation System (BAS) scale
timeFrame: routinely administrated in the psychiatric clinic upon admission
measure: Experiences with RGM-training
timeFrame: after 6 weeks of RGM-training and after 12 weeks of RGM-training
measure: Defining the temperament based personality type using the Effortful Control (EC) scale
timeFrame: routinely administrated in the psychiatric clinic upon admission
Other outcomes:
Locations:
city: Tienen
country: Belgium
facility: Alexianen Zorggroep Tienen
state: Vlaams-Brabant
Study officials:
affiliation: Vrije Universiteit Brussel - Ghent University
name: Xenia Brancart
role: PRINCIPAL_INVESTIGATOR
affiliation: Vrije Universiteit Brussel
name: Gina Rossi, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vrije Universiteit Brussel - Alexianen Zorggroep Tienen
name: Eva Dierckx, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Rudi De Raedt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Thornberg K, Josephsson S, Lindquist I. Experiences of participation in rhythm and movement therapy after stroke. Disabil Rehabil. 2014;36(22):1869-74. doi: 10.3109/09638288.2013.876107. Epub 2014 Jan 9.
citation: Bunketorp-Kall L, Lundgren-Nilsson A, Samuelsson H, Pekny T, Blomve K, Pekna M, Pekny M, Blomstrand C, Nilsson M. Long-Term Improvements After Multimodal Rehabilitation in Late Phase After Stroke: A Randomized Controlled Trial. Stroke. 2017 Jul;48(7):1916-1924. doi: 10.1161/STROKEAHA.116.016433. Epub 2017 Jun 15.