NCT04927533

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Mar 2022Jun 2027

First Submitted

Initial submission to the registry

June 2, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

5.2 years

First QC Date

June 2, 2021

Last Update Submit

May 8, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in Emotion Regulation using the Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij & Spinhoven, 2002)

    The CERQ was originally developed in Dutch. This self-report questionnaire has 36 items that evaluate the frequency of the use of emotion regulation strategies. The items are divided proportionally among nine emotion regulation strategies based on theory and empirical research: blaming yourself, blaming others, accepting, rumination, relating, catastrophising, focusing on other positive things, focusing on planning and positively reinterpreting. The items are answered on a Likert five-point scale ranging from almost never (1) to almost always (5) (Kraaij \& Garnefski, 2006; Garnefski \& Kraaij, 2006; Garnefski \& Kraaij, 2007; Nowlan et al., 2015). Variations in the total scores of the nine subscales of the CERQ will be examined.

    before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training

  • 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]).

    The four subtests are: (1)Intra-Extra Dimensional Set Shift (Cognitive Flexibility), (2) Spatial Span, (3) Spatial Working Memory and (4) Stop-Signal Task (Inhibition). For the subtest Intra-Extra Dimensional Set Shift (IED), total latency (which is the sum of the response times over all trials) and in addition the total number of errors adjusted (which is the number of incorrect stimulus choices) will be analyzed. Next outcome measure is the Spatial Span Forward Span Length (SSPFSL), which is the longest sequence that the participant can reproduce forward. The Spatial Working Memory Total Errors (SWMTE) is another outcome measure to analyze recall problems. This is a measure of the total number of selections from a box that certainly cannot contain a token. The final outcome measure of the CANTAB is the Stop Signal Task Stop Signal Reaction Time (SSTSSRT), which is the estimated time in which a participant can successfully inhibit their responses 50% of the time.

    before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training

  • Change in Core EFs (i.e. cognitive inhibition) using the California Older Adult Stroop Test (COAST)

    The COAST is a modified Stroop Color-Word Test (SCWT) that was developed specifically for older adults by Pachana and colleagues (2004). In the COAST, only three, more easily distinguishable colours (red, yellow and green) and a larger font are used to minimise the risk of errors due to colour confusion or reduced visual acuity. In addition, the number of items in the COAST was reduced (to 50 items) to minimise fatigue. For this study, we are mainly interested in the last subtest. In this subtest, colour words are presented in a different ink colour (e.g. the word GREEN with a red ink colour) and the aim is for the participants to name the ink colour and inhibit the reading automaticity. The interference score, total completion time and total error score on the interference task of the COAST will be analyzed in this study. Thus, both response/motor inhibition (using the CANTAB Stop-Signal Task) and cognitive inhibition (using the COAST) are studied.

    before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training

  • Monitor mental well-being using the Dutch version of the 14-item Warwick-Edingburgh Mental Well-Being Scale (WEMWBS)

    This questionnaire includes 14 (positively worded) items that question mental well-being (Taggart \& Stewart-Brown, 2015; Tennant et al., 2007). The questionnaire is suitable for individuals as young as 13 years old (Taggart \& Stewart-Brown, 2015). Participants are required to answer the items on a five-point scale, ranging from never (1) to always (5), according to their psychological functioning over the past two weeks. The sensitivity to change of the WEMWBS has been well validated (Taggart \& Stewart-Brown, 2015). This is important in intervention studies where pre- and post-scores are compared, which is also the aim in the current study. The research duo Taggart and Stewart-Brown (2015) compared different instruments of mental well-being and concluded that the WEMWBS is preferred (over the WHO-5) in intervention studies. The total score will be analyzed for this study. The higher the total score, the higher the level of mental well-being (Tennant et al., 2007).

    before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training

Secondary Outcomes (3)

  • Defining the temperament based personality type using the Behavioural Inhibition System (BIS)/Behavioural Activation System (BAS) scale

    routinely administrated in the psychiatric clinic upon admission

  • Experiences with RGM-training

    after 6 weeks of RGM-training and after 12 weeks of RGM-training

  • Defining the temperament based personality type using the Effortful Control (EC) scale

    routinely administrated in the psychiatric clinic upon admission

Study Arms (1)

Older adults with psychiatric problems

EXPERIMENTAL

The target group is a group of older adults with psychiatric problems (≥60 years old) admitted to a residential psychogeriatric department of the Psychiatric Clinic of the Alexians Care Group Tienen. The following exclusion criteria apply: a score of less than 21 on the MMSE (excluding dementia or other moderate to severe cognitive disorders), a mother tongue other than Dutch and having undergone surgery and/or chemotherapy in the last 3 months.

Other: Ronnie Gardiner Method

Interventions

The Ronnie Gardiner Method (RGM), developed in 1993 by Swedish jazz drummer Ronnie Gardiner, is a promising multimodal, music-based intervention with potential to stimulate and improve several cognitive functions, motor skills, reading and speech skills and social interaction. RGM participants are required to follow (what is known as) "choreoscores". This is a visual representation of the sequence of movements using four unique symbols. Each symbol represents a body half via color (red = left side, blue = right side) and the use of a body part via shape (the symbols resemble hands or feet). In addition, each movement has a specific name, based on drum sounds, which must be pronounced simultaneously. The exercises are guided by trained 'RGM-practitioners'. The course and difficulty of the session can be adapted in different ways by the RGM Practitioner, according to the capabilities of the participants.

Also known as: RGM (abbreviation)
Older adults with psychiatric problems

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Psychogeriatric inpatients aged 60+

You may not qualify if:

  • Not fluent in Dutch
  • Having undergone surgery and/or chemotherapy in the last three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexianen Zorggroep Tienen

Tienen, Vlaams-Brabant, 3300, Belgium

RECRUITING

Related Publications (3)

  • Pohl P, Dizdar N, Hallert E. The Ronnie Gardiner Rhythm and Music Method - a feasibility study in Parkinson's disease. Disabil Rehabil. 2013;35(26):2197-204. doi: 10.3109/09638288.2013.774060. Epub 2013 Mar 12.

    PMID: 23480646BACKGROUND
  • 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.

    PMID: 24400709BACKGROUND
  • 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.

    PMID: 28619985BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Xenia Brancart

    Vrije Universiteit Brussel - Ghent University

    PRINCIPAL INVESTIGATOR
  • Gina Rossi, Prof. Dr.

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR
  • Eva Dierckx, Prof. Dr.

    Vrije Universiteit Brussel - Alexianen Zorggroep Tienen

    PRINCIPAL INVESTIGATOR
  • Rudi De Raedt, Prof. Dr.

    University Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gina Rossi, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 16, 2021

Study Start

March 10, 2022

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations