NCT04966650

Brief Summary

  1. 1.Project title Effectiveness of a Brief Nursing Advice in Promoting the Psychological Well-Being for University Students with Mild to Moderate Depressive Symptoms: A Randomized Controlled Trial
  2. 2.Investigators Principal Investigator Ms. Tiffany PY CHAN, Doctor of Nursing (Year 3 candidate), School of Nursing, The University of Hong Kong (HKU) Nursing Officer, University Health Service, The Chinese University of Hong Kong (CUHK)
  3. 3.Study site Recruitment of participants will be conducted on campus in CUHK
  4. 4.Aims of the project This study aims to assess the effectiveness of a brief nursing advice in reducing depressive symptoms among university students who presented mild to moderate depressive symptoms at the University Health Service.
  5. 5.Outcomes The primary outcome of this study is the university students' decreasing level of depressive symptoms.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

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

July 8, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

9 months

First QC Date

July 8, 2021

Last Update Submit

July 18, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • depression symptoms

    Change of the level of depression symptoms

    o month, 2nd month, 6 month

Study Arms (2)

Intervention group

EXPERIMENTAL

For the intervention group, participants will receive a 5-mins brief nursing advice incorporating with Social Cognitive Theory (SCT). The protocol is about the relationship between exercise and mental health, the advantages of increase physical activity and regular exercise, and highlight the consequence if not deal with the depressive symptoms. At the 2nd month, participants will be assessed their depression symptoms via questionnaire, followed up their progress of physical activity changes and given a booster intervention. At 6th months, subjects will be assessed their depression symptoms and the level of physical activity changes via questionnaire.

Behavioral: 5-mins brief nursing advice incorporating with Social Cognitive Theory (SCT)

Control Group

NO INTERVENTION

A wellbeing leaflet from CHP will be provided to each participant. At the 2nd month, subjects will be assessed their depression symptoms via questionnaire, followed up their progress of physical activity changes and given another wellbeing leaflets. At 6th months, subjects will be assessed their depression symptoms the level of physical activity changes via questionnaire.

Interventions

The protocol is about the relationship between exercise and mental health, the advantages of increase physical activity and regular exercise, and highlight the consequence if not deal with the depressive symptoms.

Intervention group

Eligibility Criteria

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

You may not qualify if:

  • We will exclude those with actively suicidal, PHQ score \>15-19 moderately severe, 20-27 severe depressive symptoms, or those who are receiving antidepressant medication or mental health service such as counselling or psychiatric consultation, or Athletes/ \>150 minutes of moderate-intensity aerobic physical activity throughout the week, or at least 75 minutes of vigorous-intensity physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ibrahim AK, Kelly SJ, Adams CE, Glazebrook C. A systematic review of studies of depression prevalence in university students. J Psychiatr Res. 2013 Mar;47(3):391-400. doi: 10.1016/j.jpsychires.2012.11.015. Epub 2012 Dec 20.

    PMID: 23260171BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Ho Cheung Li

    The University of Hong Kong

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The data collector is blinded. Those who analyses the data, using the electronic form, do not know the group belongs to.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 19, 2021

Study Start

August 1, 2021

Primary Completion

April 30, 2022

Study Completion

June 30, 2022

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share