Stress Clinical Trial - Examining the Feasibility of a Mindfulness Booster

Status Completed

Clinical Trial Summary

The goal of this clinical trial is to examine the feasibility and acceptability of a mindfulness booster course for UK healthcare staff who have previously participated in an eight-week mindfulness course. The measures of feasibility and acceptability that will be examined include: 1. the ease with which participants are recruited to the clinical trial; 2. the extent to which participants choose to remain in the mindfulness booster course; 3. the extent to which participants choose to remain in the clinical trial; 4. how acceptable the participants find the mindfulness booster course; 5. the level of outcome measure completion; 6. whether there is a preliminary indication that the course may reduce stress. Participants will be randomly allocated to either a mindfulness booster course or a control group, who will be encouraged to continue taking care of their wellbeing as they normally would. Participants will be asked to complete questionnaires at three time-points.

Clinical Trial Description

This pilot randomised controlled trial seeks to examine the feasibility and acceptability of a mindfulness booster course for UK National Health Service staff who have previously completed an 8-week mindfulness-based intervention. Participants will be randomised to either the 8-week mindfulness booster course or a control group, in which participants will be encouraged to continue taking care of their wellbeing as they normally would. A battery of self-report measures will be administered online at baseline (weeks 0-1), mid-intervention (week 7), and post-intervention (weeks 11-12). The indices of feasibility and acceptability that will be examined include: 1. ease of recruitment; 2. participant retention in the intervention; 3. participant retention in the study; 4. acceptability of the intervention; 5. outcome measure completion; 6. whether there is a preliminary signal of efficacy on the primary outcome measure (stress). These indices will be compared to progression criteria (which are detailed in the outcome measures section) to determine whether the intervention is sufficiently feasible and acceptable to progress to a full-scale RCT in future research. ;

Study Design

Related Conditions & MeSH terms

Stress

Clinical Trial Details

NCT number	NCT05721716
Study type	Interventional
Source	Canterbury Christ Church University
Contact
Status	Completed
Phase	N/A
Start date	March 20, 2023
Completion date	August 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05130944` - Feasibility of Community Psychosocial Intervention for Women	N/A
Recruiting	`NCT06079853` - Nurse Suicide: Physiologic Sleep Health Promotion Trial	N/A
Completed	`NCT05881681` - A Mindfulness Approach to UA for Afro-descendants	N/A
Recruiting	`NCT05449002` - Digital Single Session Intervention for Youth Mental Health	N/A
Recruiting	`NCT04038190` - A Behavioral Activation Intervention Administered in a College Freshman Orientation Course	Phase 2
Completed	`NCT03931772` - Online Automated Self-Hypnosis Program	N/A
Active, not recruiting	`NCT05998161` - Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout	N/A
Completed	`NCT03728062` - Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence	N/A
Terminated	`NCT04367636` - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19	N/A
Completed	`NCT06405789` - The Effect of Yoga on Mindfulness and Perceived Stress	N/A
Recruiting	`NCT06002074` - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases	N/A
Recruiting	`NCT05273996` - Predictors of Cognitive Outcomes in Geriatric Depression	Phase 4
Completed	`NCT05245409` - Stress, EEG, ECG, and Chiropractic	N/A
Completed	`NCT04722367` - Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection	N/A
Recruiting	`NCT06273228` - Parenting Young Children in Pediatrics	N/A
Completed	`NCT06057883` - Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females	Phase 2
Completed	`NCT05312749` - The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students	N/A
Completed	`NCT05063305` - Probiotics, Immunity, Stress, and QofL	N/A
Completed	`NCT05623826` - Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager	N/A
Completed	`NCT04013451` - The Kiss of Kindness Study II	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Examining the Feasibility of a Mindfulness Booster Course for Healthcare Staff Who Attended an 8-week Mindfulness Course

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms