NCT06401252

Brief Summary

Background: Nurses who worked with patients with COVID-19 in hospitals have experienced several threatening and challenging situations, negatively affecting psychological health. M-health-based mindfulness-based interventions were found to improve psychological health in various populations. Aim: The purpose of this study is to assess the effectiveness of a m-Health-based mindfulness-based intervention on anxiety, depression, stress among Jordanian registered nurses taking care of COVID-19 patients. Methodology: The study was conducted using a pretest post-test randomized controlled design. One hundred and two nurses were recruited from a Jordanian Hospital and randomly distributed into experimental group (n=51) and control group (n= 51). The study data were collected using a self-report questionnaire working in the King Abdullah University hospital at baseline and at the end of intervention. For five weeks, the experimental group had five individual 30-minute MBI sessions. An audio-based MBI that was given to them via the WhatsApp served as the research intervention. A self-report questionnaire was used to collect the study data as follows: 1) demographic characteristics and 2) Mindful Attention Awareness, and 3) Scale the Depression, Anxiety, and Stress Scale (DASS-21). The study outcomes were measured at baseline and at the end of the intervention. Data were analyzed using the Statistical Package for Social Science (SPSS), Version 26.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2024

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

May 2, 2024

Last Update Submit

May 2, 2024

Conditions

Keywords

Mindfulness-based intervention, Stress, Depression, Anxiety, Nurses, COVID-19.

Outcome Measures

Primary Outcomes (2)

  • Depression, anxiety, and Stress Scale (DASS-21)

    The Arabic DASS was used to measure depression, anxiety and stress in the current study (Lovibond \& Lovibond, 1995). The DASS-21 is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Each of the three DASS subscales contains 7 items. Subjects were asked to use 4-point severity/frequency scales to rate the extent to which they had experienced each state. The score range of each subscale is between 0.0 to 42. Higher scores of the three subscales indicate higher levels of those emotional states. The DASS has shown acceptable levels of validity and reliability in clinical and healthy populations (Lovibond \& Lovibond, 1995).

    6 weeks

  • Mindful Attention awareness Scale

    Mindful Attention Awareness Scale (MAAS-15) was used to assess dispositional mindfulness (Brown \& Ryan, 2003). The Arabic version of MASS-15 is a valid and reliable scale (Rayan \& Ahmad, 2018). It is one-dimensional scale including 15 items measured on a six-point likert type scale, ranging from 1 (almost always) to 6 (almost never). The score range is between 15 and 90, with higher score indicting higher levels of mindfulness. The scale has shown strong psychometric properties when validated in college students. It showed single-factor construct in MAAS structure and a Chronbach's alpha of 0.82 in university sample (Brown \& Ryan, 2003).

    6 weeks

Study Arms (2)

Nurses receiving Mhealth-based mindfulness-based intervention

EXPERIMENTAL

The experimental group received five individuals 30-minute sessions of MBI for five weeks in a private and quiet room at the hospital, according to Smith's (2005) recommendation. The study intervention was an audio based MBI sent to them by the WhatsApp application. It is a free, self-paced program developed by an experienced, certified mindfulness practitioner based on the Smith's (2005) protocol to guarantee greater adherence and consistent delivery of MBI. The audio recording of the MBI was evaluated and validated for the clarity of voice and the MBI content by two psychologists who are experts in MBI.

Behavioral: Mindfulness-based intervention

Control group receiving traditional care

NO INTERVENTION

Participants in the control group were not asked to do anything during the study, except their traditional practices. However, the MBI was provided to them after the study.

Interventions

• The mindful mediators are asked to act as neutral observers who view the world as it is, without reactions, judgments, and evaluations. They quietly attend to, note, and let go of every internal external stimulus such as thought, feeing, sensation, sound, idea that enters awareness. They do not try to think about, push away, and do anything with these stimuli experienced and do not have to figure out the connections between each 19 stimuli. They simply let each stimulus come and go and wait for the next stimulus. They do not have to be concerned about distractions. Each time they are distracted, they note it as yet another passing stimulus (Ah, a distraction… how interesting")

Nurses receiving Mhealth-based mindfulness-based intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nurses taking care patients with COVID-19 in the King Abdullah University hospital (KAUH) who were aged at least 21 years old
  • had smart phones

You may not qualify if:

  • Participants who had psychological therapies or medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of Science and Technology

Irbid, None Selected, 22110, Jordan

Location

Related Publications (33)

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MeSH Terms

Conditions

Psychological Well-BeingDepressionAnxiety DisordersCOVID-19

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorBehavioral SymptomsMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single (Outcomes Assessor) The data were collected by a research assistant with good nursing experiences who were not involved in any other parts of the study. Also, the participants were randomly assigned equally to the study groups using a computerized random numbers procedure carried out by a research assistant who was not involved in any other parts of the study
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: two-group, randomized controlled design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 2, 2024

First Posted

May 6, 2024

Study Start

January 30, 2022

Primary Completion

February 1, 2024

Study Completion

April 1, 2024

Last Updated

May 6, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations