NCT05415280

Brief Summary

The interventional study would be conducted to investigate the efficacy of mindfulness based intervention in order to treat psychological stress(anxiety, depression, and stress related COVID-19), and mobile phone addiction during COVID-19 pandemic.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

February 24, 2022

Last Update Submit

June 10, 2022

Conditions

Keywords

psychological stress mobile phone addiction

Outcome Measures

Primary Outcomes (2)

  • COVID-19 related Stress

    COVID-19 related stress scale(\<5 minimum, \>72 Maximum)

    35 minutes

  • anxiety and depression

    hospitalized anxiety and depression scale (\<7 minimum, \>21 Maximum)

    15 minutes

Secondary Outcomes (1)

  • mobile phone addiction

    35 minutes

Study Arms (2)

Mindfulness based stress reduction

EXPERIMENTAL

mindfulness based stress reduction intervention was used to treat psychological and addiction problems of the individuals

Behavioral: Mindfulness Based stress reduction

Relaxation Exercise

OTHER

the control group was provided with the relaxation technique.

Behavioral: Mindfulness Based stress reduction

Interventions

The aim of the psychological intervention to reduce the mental health problems of the participants.

Mindfulness based stress reductionRelaxation Exercise

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The participants fulfil the age criteria, students from public and private universities, and provided signed informed consent.

You may not qualify if:

  • Participant suffering from chronic physical or psychological disorder. In addition participant who experience death of loved ones during COVID-19 pandemic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zia-Un Nisa

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • zia-un Nisa

    assisstant professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2022

First Posted

June 13, 2022

Study Start

August 1, 2022

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

June 14, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

The investigator has not plan to share data without taking permission from the study participants.

Locations