- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04870385
An Islamic Psychospiritual-Acceptance and Commitment-based Prevention Program for At-risk Young Adults in the COVID-19 Pandemic
August 30, 2021 updated by: Jamilah Hanum Abdul Khaiyom, PhD, International Islamic University Malaysia
An Islamic Psychospiritual-Acceptance and Commitment-based Prevention Program for At-Risk Young Adults in the COVID-19 Pandemic
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Selangor
-
Kuala Lumpur, Selangor, Malaysia, 53100
- International Islamic University Malaysia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 29 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
5-week online prevention program
|
Online modular psychological prevention program featuring integrated elements of Islamic spirituality and Acceptance and Commitment Therapy (ACT).
|
Other: Control
Waitlist control
|
Control group waitlisted to receive prevention program after completion of final data collection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in psychological distress
Time Frame: 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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in psychological flexibility
Time Frame: 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
|
Measured using the Acceptance and Action Questionnaire (AAQ-II; Bond et al., 2011; Hayes et al., 2004).
|
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.
Time Frame: 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
|
Measured through the Self-Compassion Scale (SCS; Neff 2003; Neff, 2015).
|
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
Time Frame: 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
|
Measured by the Brief Resilience Scale (BRS; Smith et al., 2008).
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jamilah Hanum Abdul Khaiyom, PhD, International Islamic University Malaysia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2021
Primary Completion (Actual)
June 25, 2021
Study Completion (Anticipated)
August 1, 2021
Study Registration Dates
First Submitted
April 7, 2021
First Submitted That Met QC Criteria
April 28, 2021
First Posted (Actual)
May 3, 2021
Study Record Updates
Last Update Posted (Actual)
August 31, 2021
Last Update Submitted That Met QC Criteria
August 30, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPI21-052-0052
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psychological Distress
-
Utah State UniversityRecruitingPsychological Distress | Psychological Flexibility | Psychological Well-BeingUnited States
-
University of Campania "Luigi Vanvitelli"RecruitingPsychological Distress | Psychological Intervention | University StudentsItaly
-
Gunther MeinlschmidtRecruitingPsychological DistressGermany
-
Duke UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Recruiting
-
University of WaterlooActive, not recruitingPsychological DistressCanada
-
Dokuz Eylul UniversityActive, not recruitingPsychological DistressTurkey
-
VA Eastern Colorado Health Care SystemUniversity of Colorado, Denver; Military Suicide Research ConsortiumCompletedPsychological DistressUnited States
-
University of ZurichFreie Universität BerlinTerminatedPsychological DistressSwitzerland, Germany
-
Combat StressRoyal British LegionCompletedPsychological DistressUnited Kingdom
-
Norwegian Knowledge Centre for the Health ServicesUniversity of Oslo; University of Tromso; Norwegian Medical AssociationUnknown
Clinical Trials on 5-week prevention program
-
Basque Health ServicePreventive Services and Health Promotion Research Network; Castilla-León Health... and other collaboratorsCompletedCoronary Heart DiseaseSpain
-
University of ArizonaSuspendedPreDiabetes | Type 2 DiabetesUnited States
-
The Hong Kong Polytechnic UniversityCompletedTotal Knee ArthroplastyHong Kong
-
Beth Israel Deaconess Medical CenterNational Center for Complementary and Integrative Health (NCCIH)Completed
-
University Hospital, ToursNot yet recruiting
-
University of South FloridaCompletedBreast CancerUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); The Arthritis Society, Canada; Michael Smith Foundation for Health ResearchCompletedArthritis | Osteoarthritis | Osteo Arthritis Knee | Anterior Cruciate Ligament Tear | Knee Injuries | Meniscus Tear | Arthritis KneeCanada
-
Montana State UniversityCompletedDiabetes Mellitus, Type 2United States
-
Baylor Research InstituteUniversity of North Texas Health Science CenterCompletedObesity | Pre-diabetesUnited States
-
The University of Texas Medical Branch, GalvestonWithdrawnHypertension | Prediabetic State | Overweight or Obesity | Gestational Weight Gain