The Ronnie Gardiner Method Effectiveness Study
NCT04927533, Not applicable, Recruiting, Universitair Ziekenhuis Brussel
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Ronnie Gardiner Method Effectiveness Study | ClinicalTrials.gov |
| NCT number | NCT04927533 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Universitair Ziekenhuis Brussel | ClinicalTrials.gov |
| Conditions | Psychiatric Disorder | ClinicalTrials.gov |
| Interventions | Ronnie Gardiner Method | ClinicalTrials.gov |
| First posted | 2021-06-16 | ClinicalTrials.gov |
| Last updated | 2023-05-09 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Emotion Regulation using the Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski, Kraaij & Spinhoven, 2002) | 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. | ClinicalTrials.gov |
| Primary | 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]). | 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. | ClinicalTrials.gov |
| Primary | Change in Core EFs (i.e. cognitive inhibition) using the California Older Adult Stroop Test (COAST) | 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. | ClinicalTrials.gov |
| Primary | Monitor mental well-being using the Dutch version of the 14-item Warwick-Edingburgh Mental Well-Being Scale (WEMWBS) | 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). | ClinicalTrials.gov |
| Secondary | 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 | 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. | ClinicalTrials.gov |
| Secondary | Experiences with RGM-training | after 6 weeks of RGM-training and after 12 weeks of 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. | ClinicalTrials.gov |
| Secondary | Defining the temperament based personality type using the Effortful Control (EC) scale | routinely administrated in the psychiatric clinic upon admission | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 3
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Intra/Extra Dimensional Set Shift | Primary outcome | ConductCognition |
| Stop-Signal Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)