Psychiatric DisorderNCT04927533
The Ronnie Gardiner Method Effectiveness Study
A study testing Ronnie Gardiner Method in people with Psychiatric Disorder, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Psychiatric Disorder
- What is being tested?
- Ronnie Gardiner Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Mar 2022to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Psychogeriatric inpatients aged 60+
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Alexianen Zorggroep Tienen
Tienen, Vlaams-Brabant, 3300
Eva Dierckx, Prof. Dr., +32496923613, eva.dierckx@azt.broedersvanliefde.be
About this study
Official title: Improving Cognitive and Emotional Processing in Older (Psychiatric) Patients: the Transdiagnostic Effectiveness of the Ronnie Gardiner Method (RGM).
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.
- Conditions
- Psychiatric Disorder
- Being tested
- Ronnie Gardiner Method
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ronnie Gardiner MethodOther
Also called RGM (abbreviation)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Ronnie Gardiner Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
The BIS/BAS scale is a Dutch personality questionnaire that assesses fear-related avoidance behavior (BIS scale) and reward-related approach behavior (BAS scale) (Gray, 1970). The 24 items can be subdivided into four scales, three of which are related to the BAS scale (i.e. fun seeking, drive en reward responsiveness) and lastly the BIS scale (Franken et al., 2005).
The BIS and BAS total scores will be used to determine membership to a particular personality type.
Measured: routinely administrated in the psychiatric clinic upon admission
Experiences with RGM-training
In order to investigate the contribution of positive experiences to the effectiveness of RGM, the research team has developed a short questionnaire. This questionnaire includes three questions that directly and indirectly question the experiences in RGM. The three questions are: "To what extent do you find the RGM training enjoyable?", "To what extent would you recommend the RGM training to your fellow patients?" and "To what extent would you participate in the RGM training again?". Participants should answer the questions on a ten-point scale ranging from "not at all" (1) to "very much" (10). The higher the total score (outcome measure), the higher the positive experience of the RGM training.
Measured: 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
The 19-item Effortful Control Scale (ECS; Evans \& Rothbart, 2007; Dutch version, Hartman \& Rothbart, 2001) is a scale of the Adult Temperament Questionnaire (ATQ) that questions the extent to which an individual can direct his or her attention (i.e. attention control), can activate a response (i.e. activation control) and the ability to inhibit inappropriate behavior (i.e. inhibitory control). The three subscales of the ECS reflect the aforementioned concepts.
The EC total score will be used to determine membership to a particular personality type.
Measured: routinely administrated in the psychiatric clinic upon admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start10 Mar 2022
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatric Clinic of Alexianen Zorggroep Tienen
- Responsible party
- Principal investigator, Xenia Brancart, Universitair Ziekenhuis Brussel
- Investigators
- Xenia Brancart, Principal investigator, Vrije Universiteit Brussel - Ghent UniversityGina Rossi, Prof. Dr., Principal investigator, Vrije Universiteit BrusselEva Dierckx, Prof. Dr., Principal investigator, Vrije Universiteit Brussel - Alexianen Zorggroep TienenRudi De Raedt, Prof. Dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927533
- Sponsor's protocol ID
- B.U.N. 1432021000379
- Status last verified
- May 2023
- First submitted
- 2 Jun 2021
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23480646Thornberg 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.
PubMed 24400709Bunketorp-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.
PubMed 28619985
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cognitive and Emotional Processing in Older (Psychiatric) Patients: the Transdiagnostic Effectiveness of the Ronnie Gardiner Method (RGM).
- ClinicalTrials.gov ID
- NCT04927533
- Acronym / sponsor ID
- B.U.N. 1432021000379
- Conditions
- Psychiatric Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Psychiatric Clinic of Alexianen Zorggroep Tienen
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Jun 2021 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults with psychiatric problems | Experimental | Other: Ronnie Gardiner MethodThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Psychogeriatric inpatients aged 60+
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Ronnie Gardiner MethodAlso: RGM (abbreviation)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. | Other | Older adults with psychiatric problems |
Primary outcome
Change in Emotion Regulation using the Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij & Spinhoven, 2002)
Time frame: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training
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.
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]).
Time frame: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training
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.
Change in Core EFs (i.e. cognitive inhibition) using the California Older Adult Stroop Test (COAST)
Time frame: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training
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.
Monitor mental well-being using the Dutch version of the 14-item Warwick-Edingburgh Mental Well-Being Scale (WEMWBS)
Time frame: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training
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).
3 secondary outcomes
Defining the temperament based personality type using the Behavioural Inhibition System (BIS)/Behavioural Activation System (BAS) scale
Time frame: routinely administrated in the psychiatric clinic upon admission
Experiences with RGM-training
Time frame: 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
Time frame: routinely administrated in the psychiatric clinic upon admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 23480646Pohl 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.
- Background: PubMed 24400709Thornberg 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.
- Background: PubMed 28619985Bunketorp-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.
- Individual participant dataSharing planned: No
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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.
Xenia Brancart principal investigator
Vrije Universiteit Brussel - Ghent University
Gina Rossi, Prof. Dr. principal investigator
Vrije Universiteit Brussel
Eva Dierckx, Prof. Dr. principal investigator
Vrije Universiteit Brussel - Alexianen Zorggroep Tienen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ronnie Gardiner Method in people with Psychiatric Disorder, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 May 2023. 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 Belgium. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xenia Brancart (+32475791763, xenia.christiane.brancart@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Emotion Regulation using the Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij & Spinhoven, 2002) (time frame: before the start of RGM-training, after 6 weeks of RGM-training and after 12 weeks of RGM-training). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04927533, which also lists 3 linked publications.
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 9 May 2023.