Prepare the Mind: Can Coaching in Goal-directed Behaviour Increase the Success of Cognitive Rehabilitation in People With MS?
NCT07225868, Not applicable, Recruiting, Universiteit Leiden
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Prepare the Mind: Can Coaching in Goal-directed Behaviour Increase the Success of Cognitive Rehabilitation in People With MS? | ClinicalTrials.gov |
| NCT number | NCT07225868 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 126 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Universiteit Leiden | ClinicalTrials.gov |
| Conditions | Multiple Sclerosis | ClinicalTrials.gov |
| Interventions | Conscientiousness Coaching Before Cognitive Rehabilitation, Sham Intervention Before Cognitive Rehabilitation | ClinicalTrials.gov |
| First posted | 2025-11-10 | ClinicalTrials.gov |
| Last updated | 2025-11-10 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Objective cognitive changes between baseline and post-intervention | Between baseline and week 18. | Objective cognitive changes between baseline and post intervention will be assessed using the Symbol Digit Modalities Test assessing information processing speed. | ClinicalTrials.gov |
| Primary | Subjective cognitive changes between baseline and post-intervention | Between baseline and week 18. | Subjective cognitive changes between baseline and post intervention will be assessed using the Multiple Sclerosis Instrumental Activities of Daily Living Questionnaire. | ClinicalTrials.gov |
| Secondary | Changes between baseline and week 18 on meaning of life in the intervention compared to the sham intervention group. | Between baseline and week 18. | Changes on the Meaning of Life Questionnaire comparing the intervention (C-Coach prior to CR) group with the sham intervention group. | ClinicalTrials.gov |
| Secondary | Changes between baseline and week 18 on fatigue in the intervention compared to the sham intervention group. | Between baseline and week 18. | Changes on the Checklist of Individual Strength comparing the intervention (C-Coach prior to CR) group with the sham intervention group. | ClinicalTrials.gov |
| Secondary | Changes between baseline and week 18 on quality of life in the intervention compared to the sham intervention group. | Between baseline and week 18. | Changes on the 36-Item Short Form Survey comparing the intervention (C-Coach prior to CR) group with the sham intervention group. | ClinicalTrials.gov |
| Secondary | Changes between baseline and week 18 on psychological outcomes in the intervention compared to the sham intervention group. | Between baseline and week 18. | Changes on the Hospital Anxiety and Depression Scale comparing the intervention (C-Coach prior to CR) group with the sham intervention group. | ClinicalTrials.gov |
| Secondary | Changes between week 12 and week 18 on goal attainment in the intervention compared to the sham intervention group. | Between week 12 and week 18. | Changes on the Goal Attainment Scale comparing the intervention (C-Coach prior to CR) group with the sham intervention group. | ClinicalTrials.gov |
| Secondary | Changes between baseline and week 18 on multiple sclerosis specific cognitive functioning in the intervention compared to the sham intervention group. | Between baseline and week 18. | Changes on the Brief International Cognitive Assessment for Multiple Sclerosis comparing the intervention (C-Coach prior to CR) group with the sham intervention group. | ClinicalTrials.gov |
| Secondary | Changes between baseline and week 18 on cognitive flexibility in the intervention compared to the sham intervention group. | Between baseline and week 18. | Changes on the Trail Making Test A and B comparing the intervention (C-Coach prior to CR) group with the sham intervention group. | ClinicalTrials.gov |
| Secondary | Changes between baseline and week 18 on verbal fluency in the intervention compared to the sham intervention group. | Between baseline and week 18. | Changes on the Controlled Oral Word Association Test comparing the intervention (C-Coach prior to CR) group with the sham intervention group. | ClinicalTrials.gov |
| Secondary | Changes between baseline and week 18 executive functions in the intervention compared to the sham intervention group. | Between baseline and week 18. | Changes on the Stroop Test comparing the intervention (C-Coach prior to CR) group with the sham intervention group. | ClinicalTrials.gov |
| Secondary | Changes between baseline and week 18 on functional networks in the intervention compared to the sham intervention group. | Between baseline and week 18. | Changes on functional networks measured with resting state functional magnetic resonance imaging comparing the intervention (C-Coach prior to CR) group with the sham intervention group. | ClinicalTrials.gov |
| Secondary | Changes between baseline and week 18 on structural networks in the intervention compared to the sham intervention group. | Between baseline and week 18. | Changes on Structural networks measured with Diffusion Tensor Imaging comparing the intervention (C-Coach prior to CR) group with the sham intervention group. | ClinicalTrials.gov |
| Secondary | Changes between baseline and week 18 on social outcomes in the intervention compared to the sham intervention group. | Between baseline and week 18. | Changes on the Medical Outcomes Study Social Support Survey comparing the intervention (C-Coach prior to CR) group with the sham intervention group. | ClinicalTrials.gov |
| Other | Effect of personality | Between baseline and week 18. | The effect of baseline trait conscientiousness, neuroticism and personality measured with the Big Five Inventory 2 on all outcomes. | ClinicalTrials.gov |
| Other | Effect of demographics | Between baseline and week 18. | The effect of baseline demographic variables, namely age, sex, nationality, and education will be studied on the described outcomes. | ClinicalTrials.gov |
| Other | Effect of C-Coach | Between baseline and week 12. | The main and secondary outcomes will be measured at week 12 after C-Coach or sham intervention and before the start of CR in order to replicate previous preliminary findings. | ClinicalTrials.gov |
| Other | Feedback on C-Coach or sham intervention | At week 18. | Participants' responses to a Feedback Questionnaire will be examined at week 18, which includes specific questions about the effectiveness and the experience of the intervention. | 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 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
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 5
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 |
|---|---|---|
| Symbol Coding | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary 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)