Psychological DistressNCT04870385
An Islamic Psychospiritual-Acceptance and Commitment-based Prevention Program for At-risk Young Adults in the COVID-19 Pandemic
A study testing 5-week prevention program in people with Psychological Distress, run by International Islamic University Malaysia at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- What is being tested?
- 5-week prevention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteMalaysia
- Study dates
- 11 Apr 2021to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
International Islamic University Malaysia
Kuala Lumpur, Selangor, 53100
About this study
Official title: 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.
- Conditions
- Psychological Distress
- Being tested
- 5-week prevention program, Control
- Keywords
- Acceptance and Commitment Therapy (ACT), Islamic psychospiritual intervention, Online intervention, COVID-19, Prevention program
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-week prevention programBehavioural
Online modular psychological prevention program featuring integrated elements of Islamic spirituality and Acceptance and Commitment Therapy (ACT).
ControlBehavioural
Control group waitlisted to receive prevention program after completion of final data collection.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 5-week online prevention program Receives: Behavioral: 5-week prevention program |
| Control | Other | Waitlist control Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in psychological distress
Measured using the Depression, Anxiety, and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995).
Measured: 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 using the Acceptance and Action Questionnaire (AAQ-II; Bond et al., 2011; Hayes et al., 2004).
Measured: 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 through the Self-Compassion Scale (SCS; Neff 2003; Neff, 2015).
Measured: 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 by the Brief Resilience Scale (BRS; Smith et al., 2008).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start11 Apr 2021
- Primary completion25 Jun 2021
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Islamic University Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- International Institute of Islamic Thought
- Responsible party
- Principal investigator, Jamilah Hanum Abdul Khaiyom, PhD, International Islamic University Malaysia
- Investigators
- Jamilah Hanum Abdul Khaiyom, PhD, Principal investigator, International Islamic University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870385
- Sponsor's protocol ID
- SPI21-052-0052
- Status last verified
- Aug 2021
- First submitted
- 7 Apr 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Islamic Psychospiritual-Acceptance and Commitment-based Prevention Program for At-Risk Young Adults in the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04870385
- Acronym / sponsor ID
- SPI21-052-0052
- Conditions
- Psychological Distress
- Keywords
- Acceptance and Commitment Therapy (ACT), Islamic psychospiritual intervention, Online intervention, COVID-19, Prevention program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- International Islamic University MalaysiaUniversity, hospital or other
- Collaborators
- International Institute of Islamic Thought
- Study start
- 11 Apr 2021 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- Aug 2021 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomised parallel interventional study model in which there will be 2 groups, an intervention group and a waitlist control group.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: 5-week prevention program5-week online prevention program |
| Control | Other | Behavioral: ControlWaitlist control |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-week prevention programOnline modular psychological prevention program featuring integrated elements of Islamic spirituality and Acceptance and Commitment Therapy (ACT). | Behavioural | Treatment |
| ControlControl group waitlisted to receive prevention program after completion of final data collection. | Behavioural | Control |
Primary outcome
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).
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamilah Hanum Abdul Khaiyom, PhD principal investigator
International Islamic University Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-week prevention program in people with Psychological Distress, run by International Islamic University Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.