Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001480875
Ethics application status
Approved
Date submitted
17/03/2021
Date registered
29/10/2021
Date last updated
29/10/2021
Date data sharing statement initially provided
29/10/2021
Date results information initially provided
29/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A feasibility study of a remotely delivered brief psychological intervention targeted at well-being of international students
Scientific title
A feasibility study of a remotely delivered brief psychological intervention targeted at well-being of international students
Secondary ID [1] 303717 0
Nill known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wellbeing 321140 0
Depression 321141 0
Anxiety 321142 0
Condition category
Condition code
Mental Health 318943 318943 0 0
Depression
Mental Health 318944 318944 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of 3 weekly online group sessions, delivered via Zoom videoconferencing app, lasting about one hour each. Sessions will be delivered by psychology graduates trained and experienced in the intervention by Each group will consist of 6-8 participants/students. Intervention teaches 3 strategies; Stress management through relaxation, behavioral activation and strengthening and seeking social support. Session 1 provides information about common reactions to adversity, psychoeducation about common mental disorders (anxiety, depression and stress), and trains participants in a basic stress management strategy (slow breathing). Session 2 introduces behavioral activation during which participants are encouraged to re-engage gradually with pleasant activities to improve well-being. Sessions 3 support participants’ continued application of behavioral activation and stress management and introduce strategies to strengthen social support networks retaining intervention gains. Adherence to intervention is monitored through the practice of strategies given as home work (completed on worksheets) as well as session attendance from session records.
Intervention code [1] 320025 0
Behaviour
Intervention code [2] 320026 0
Prevention
Comparator / control treatment
nill
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326870 0
Feasibility and acceptability: The primary outcome will be feasibility and acceptability of intervention measured using a composite of the following indicators;
1. Delivery of intervention with at least 75% fidelity using a structured tool ENACT: Enhancing Competence in Common therapeutic factors adapted for current intervention.
2. Retention of at least 50% by the completion of 3 intervention sessions ( Data from attendance records of participants)
3. Retention rate of 60% at post-assessment
4. Mean score of 22 (70%) or above on Client Satisfaction Questionnaire
Timepoint [1] 326870 0
Baseline and one week post-intervention
Secondary outcome [1] 392923 0
Symptoms of depression as assessed by Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 392923 0
Baseline and one week post-intervention
Secondary outcome [2] 392935 0
Symptoms of Anxiety as measured by Generalized Anxiety Disorder Scale (GAD-7)
Timepoint [2] 392935 0
Baseline and One week Post intervention
Secondary outcome [3] 392936 0
Wellbeing/positive mental health as measured by WHO-5 Wellbeing index (WHO-5)
Timepoint [3] 392936 0
Baseline and One week Post intervention
Secondary outcome [4] 392937 0
Ways of Coping Checklist to assess coping strategies used by participants
Timepoint [4] 392937 0
Baseline and One week Post intervention

Eligibility
Key inclusion criteria
All the Pakistani international students, enrolled in any university in China in a degree program (undergraduate, masters or PhD), currently residing in Pakistan due to COVID-19 travel restrictions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be exclude if they are not familiar with Zoom videoconferencing app, do not have a stable internet connection and an electronic device to attend the group sessions.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/03/2021
Date of last participant enrolment
Anticipated
Actual
6/06/2021
Date of last data collection
Anticipated
Actual
6/07/2021
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 23540 0
Pakistan
State/province [1] 23540 0

Funding & Sponsors
Funding source category [1] 308017 0
University
Name [1] 308017 0
Xi'an Jiaotong University
Country [1] 308017 0
China
Primary sponsor type
University
Name
Xi'an Jiaotong University
Address
Xi'an Jiaotong university, 76 West Yanta District, Xi'an, 76 West Yanta District, Xi'an
Postcode 710061,
Country
China
Secondary sponsor category [1] 308887 0
None
Name [1] 308887 0
Address [1] 308887 0
Country [1] 308887 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308007 0
Xi'an Jiaotong biomedical ethics committee
Ethics committee address [1] 308007 0
Xi'an Jiaotong biomedical ethics committee,
Xi'an jioatong University, 76 West Yanta Road, Xi'an
Postcode 710061,
Ethics committee country [1] 308007 0
China
Date submitted for ethics approval [1] 308007 0
16/03/2021
Approval date [1] 308007 0
17/03/2021
Ethics approval number [1] 308007 0

Summary
Brief summary
Mental health of university students is a growing concern all over the globe, particularly in the context of Covid-19 pandemic. Problem management Plus (PM+) is a 5-session group intervention incorporating stress management, behavioral activation and social support strategies, delivered by non-specialist healthcare workers and has been found to be effective in reducing symptoms of psychological distress among different groups. The aim of the present study is to evaluate the feasibility and acceptability of a remotely delivered adapted PM+ intervention in improving psychological well-being amongst a group of Pakistani international students enrolled in Chinese universities, but who are unable to return to campuses due to COVID-19 travel restrictions.
A single arm pre-post study to evaluate the feasibility of the group intervention will be conducted. 30 participants will be recruited. Intervention will be delivered via Zoom videoconferencing app by trained non-specialists. Outcome assessments will be conducted immediately after the completion of the intervention. The primary outcome will be feasibility and acceptability of intervention (measured in terms of client satisfaction , intervention fidelity, recruitment and drop-out rates and no. of intervention sessions completed by participants). Secondary outcome is change in the scores of clinical outcomes measured by Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder scale (GAD-7), ways of coping checklist and WHO-5 well-being index) from baseline to post-intervention. Outcomes from this study will contribute to furnish evidence on acceptability, feasibility and of this approach for improving psychological well-being of international students.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109210 0
Miss Parveen Akhtar
Address 109210 0
School of public Health, Xi'an Jiaotong University,
76 West Yanta Road, Xian. P.R. China
Postcode 710061,
Country 109210 0
China
Phone 109210 0
+862982655450
Fax 109210 0
Email 109210 0
[email protected]
Contact person for public queries
Name 109211 0
Miss Parveen Akhtar
Address 109211 0
School of public Health, Xi'an Jiaotong University,
76 West Yanta Road, Xian. P.R. China
Postcode 710061,
Country 109211 0
China
Phone 109211 0
+862982655450
Fax 109211 0
Email 109211 0
[email protected]
Contact person for scientific queries
Name 109212 0
Miss Parveen Akhtar
Address 109212 0
School of public Health, Xi'an Jiaotong University,
76 West Yanta Road, Xian. P.R. China
Postcode 710061,
Country 109212 0
China
Phone 109212 0
+862982655450
Fax 109212 0
Email 109212 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.