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An Islamic Psychospiritual-Acceptance and Commitment-based Prevention Program for At-risk Young Adults in the COVID-19 Pandemic

Primary Purpose

Psychological Distress

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
5-week prevention program
Control
Sponsored by
International Islamic University Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychological Distress focused on measuring Acceptance and Commitment Therapy (ACT), Islamic psychospiritual intervention, Online intervention, COVID-19, Prevention program

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • International Islamic University Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment

Control

Arm Description

5-week online prevention program

Waitlist control

Outcomes

Primary Outcome Measures

Changes in psychological distress
Measured using the Depression, Anxiety, and Stress Scale (DASS-21; Lovibond & Lovibond, 1995).

Secondary Outcome Measures

Changes in psychological flexibility
Measured using the Acceptance and Action Questionnaire (AAQ-II; Bond et al., 2011; Hayes et al., 2004).
Changes in self-compassion.
Measured through the Self-Compassion Scale (SCS; Neff 2003; Neff, 2015).
Changes in resilience
Measured by the Brief Resilience Scale (BRS; Smith et al., 2008).

Full Information

First Posted
April 7, 2021
Last Updated
August 30, 2021
Sponsor
International Islamic University Malaysia
Collaborators
International Institute of Islamic Thought
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1. Study Identification

Unique Protocol Identification Number
NCT04870385
Brief Title
An Islamic Psychospiritual-Acceptance and Commitment-based Prevention Program for At-risk Young Adults in the COVID-19 Pandemic
Official Title
An Islamic Psychospiritual-Acceptance and Commitment-based Prevention Program for At-Risk Young Adults in the COVID-19 Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 11, 2021 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Islamic University Malaysia
Collaborators
International Institute of Islamic Thought

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Distress
Keywords
Acceptance and Commitment Therapy (ACT), Islamic psychospiritual intervention, Online intervention, COVID-19, Prevention program

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomised parallel interventional study model in which there will be 2 groups, an intervention group and a waitlist control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
5-week online prevention program
Arm Title
Control
Arm Type
Other
Arm Description
Waitlist control
Intervention Type
Behavioral
Intervention Name(s)
5-week prevention program
Intervention Description
Online modular psychological prevention program featuring integrated elements of Islamic spirituality and Acceptance and Commitment Therapy (ACT).
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Control group waitlisted to receive prevention program after completion of final data collection.
Primary Outcome Measure Information:
Title
Changes in psychological distress
Description
Measured using the Depression, Anxiety, and Stress Scale (DASS-21; Lovibond & Lovibond, 1995).
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
Secondary Outcome Measure Information:
Title
Changes in psychological flexibility
Description
Measured using the Acceptance and Action Questionnaire (AAQ-II; Bond et al., 2011; Hayes et al., 2004).
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
Title
Changes in self-compassion.
Description
Measured through the Self-Compassion Scale (SCS; Neff 2003; Neff, 2015).
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
Title
Changes in resilience
Description
Measured by the Brief Resilience Scale (BRS; Smith et al., 2008).
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamilah Hanum Abdul Khaiyom, PhD
Organizational Affiliation
International Islamic University Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Islamic University Malaysia
City
Kuala Lumpur
State/Province
Selangor
ZIP/Postal Code
53100
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

An Islamic Psychospiritual-Acceptance and Commitment-based Prevention Program for At-risk Young Adults in the COVID-19 Pandemic

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