NCT04870385

Brief Summary

The COVID-19 pandemic has increased mental health concerns worldwide, and young adults are at higher risk of experiencing increased psychological distress due to the pandemic. University students face compounding stressors during the pandemic, such as online and remote learning, economic insecurity, and uncertain career prospects. This study aims to evaluate the effectiveness of an online modular prevention program featuring integrated elements of Acceptance and Commitment Therapy (ACT) and Islamic spirituality in reducing the psychological distress and increasing the psychological flexibility, self-compassion, and resilience of Muslim university students in Malaysia.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

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

April 7, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

April 11, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

April 7, 2021

Last Update Submit

August 30, 2021

Conditions

Psychological Distress

Keywords

Acceptance and Commitment Therapy (ACT)Islamic psychospiritual interventionOnline interventionCOVID-19Prevention program

Outcome Measures

Primary Outcomes (1)

  • Changes in psychological distress

    Measured using the Depression, Anxiety, and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995).

    Measured at pre-intervention, mid-intervention (third week of prevention program), post-intervention (up to 1-week after completion of program), and 1-month follow-up

Secondary Outcomes (3)

  • Changes in psychological flexibility

    Measured at pre-intervention, mid-intervention (third week of prevention program), post-intervention (up to 1-week after completion of program), and 1-month follow-up

  • Changes in self-compassion.

    Measured at pre-intervention, mid-intervention (third week of prevention program), post-intervention (up to 1-week after completion of program), and 1-month follow-up

  • Changes in resilience

    Measured at pre-intervention, mid-intervention (third week of prevention program), post-intervention (up to 1-week after completion of program), and 1-month follow-up

Study Arms (2)

Treatment

EXPERIMENTAL

5-week online prevention program

Behavioral: 5-week prevention program

Control

OTHER

Waitlist control

Behavioral: Control

Interventions

5-week prevention programBEHAVIORAL

Online modular psychological prevention program featuring integrated elements of Islamic spirituality and Acceptance and Commitment Therapy (ACT).

Treatment
ControlBEHAVIORAL

Control group waitlisted to receive prevention program after completion of final data collection.

Control

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Undergraduate or postgraduate student enrolled in a Malaysian university
  • aged 18-29 years old
  • Obtained moderate and above levels in either one of the stress, anxiety, and depression subscales of the DASS-21 pre-intervention assessment
  • Muslim
  • Owns a gadget with Internet access
  • Can read and understand English

You may not qualify if:

  • Those with previous experience with a modular ACT-based treatment with Islamic elements
  • Those with past or present diagnosis of mental/neurological disorder
  • Those reporting active suicidality
  • Those involved in any other form of psychological treatment (ie. psychotherapy, pharmacotherapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Islamic University Malaysia

Kuala Lumpur, Selangor, 53100, Malaysia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jamilah Hanum Abdul Khaiyom, PhD

    International Islamic University Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomised parallel interventional study model in which there will be 2 groups, an intervention group and a waitlist control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 7, 2021

First Posted

May 3, 2021

Study Start

April 11, 2021

Primary Completion

June 25, 2021

Study Completion

August 1, 2021

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)