Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT07155512
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2025-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of a Bespoke Mindfulness Intervention for Registered Dietitians on Resilience, Burnout and Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-26', 'size': 340482, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-08-09T09:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resilience', 'timeFrame': 'Baseline, immediately after intervention (at the end of the last session of the 4 week intervention), 3 months post intervention, 6 months post intervention', 'description': 'Measured using validated tool: Brief Resilience Scale. Scores range from 1-5. Higher scores = higher level of resilience. 1.00-2.99= Low resilience; 3.00-4.30 = Normal resilience; 4.31-5.00= High resilience.'}], 'secondaryOutcomes': [{'measure': 'Burnout', 'timeFrame': 'Baseline, immediately post (this survey is administered at the end of the 4th and final session of the intervention, which was week 4), 3 months post, 6 months post intervention', 'description': 'Measured using validated tool: Maslach Burnout Inventory, which has 3 domains which have the following scoring:\n\nEmotional Exhaustion (EE): \\</=17 low/more favourable; 18-29 moderate; \\>/= 30 high / least favourable Depersonalisation (DP): \\</=5 low/ more favourable; 6-11moderate; \\>/=12 high / least favourable Personal Accomplishment (PA): \\</=33 low / least favourable; 34-39moderate; \\</=40 high / most favourable'}, {'measure': 'Stress', 'timeFrame': 'Baseline, immediately post intervention (this survey was given at the end of the 4th and final session of the intervention), 3 months post intervention, 6 months post intervention', 'description': 'Measured using validated tool: Perceived Stress Scale - scores range from 0-40 with higher scores indicating higher levels of perceived stress.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Registered Dietitian', 'Mindfulness', 'Randomised control trial', 'Resilience', 'Burnout', 'Stress', 'Mindfulness based intervention', 'Health personnel', 'Continuing professional development', 'Occupational health'], 'conditions': ['Resilience, Psychological', 'Burnout, Professional', 'Stress, Psychological']}, 'descriptionModule': {'briefSummary': 'The goal of this randomised control trial is to find out whether a mindfulness based intervention can improve mental well-being for Registered Dietitians (RD) in the UK. The main question it aims to answer is:\n\nCan a mindfulness based intervention improve resilience amongst UK RDs?\n\nCan a mindfulness based intervention reduce stress and burnout amongst UK RDs?\n\nResearchers will compare participants who attend a structured mindfulness based intervention with a waitlist control group to see if there is a difference in outcome measures between the groups before the intervention, immediately after, 3 months after and 6 months after.\n\nParticipants in the intervention group will be invited to an online mindfulness course that was written especially for this study. Participants in both groups will be asked to complete surveys before the intervention, immediately after, 3 months after and 6 months after. Participants in the intervention group will also be invited to participate in a one to one interview to discuss their experiences, barriers and facilitators to mindfulness in dietetic practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A Registered Dietitian currently practicing in the UK\n* Willing and able to participate in 4 x 50 minute CPD sessions relating to mindfulness in dietetic practice (one session per week)\n* Willing and able to complete all of the surveys (pre-intervention, immediately post, 3 months post and 6 months post intervention)\n\nExclusion Criteria:\n\n* A diagnosis of a psychotic condition\n* A diagnosis of epilepsy or asthma that is not well controlled'}, 'identificationModule': {'nctId': 'NCT07155512', 'briefTitle': 'Impact of a Bespoke Mindfulness Intervention for Registered Dietitians on Resilience, Burnout and Stress', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'The Impact of a Bespoke Mindfulness Intervention for Registered Dietitians on Resilience, Burnout and Stress - A Cluster Randomised Control Trial', 'orgStudyIdInfo': {'id': 'FMHS 70-1123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness based intervention', 'description': 'Mindfulness based intervention (delivered synchronous online)', 'interventionNames': ['Behavioral: Mindfulness based intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control group', 'description': 'No intervention provided during the data collection period. Mindfulness based intervention delivered after data collection period.'}], 'interventions': [{'name': 'Mindfulness based intervention', 'type': 'BEHAVIORAL', 'description': 'A mindfulness intervention was designed especially for this study and delivered by a RD also qualified as a mindfulness teacher. The intervention was delivered synchronously online and consisted of 4 x 50 minute sessions delivered across 4 weeks.', 'armGroupLabels': ['Mindfulness based intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LE12 5RD', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'University of Nottingham', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data collected in respect of 3 outcomes measured (resilience, burnout and stress) can be shared if required.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}