Integrated Mindfulness-Based Cognitive Therapy for Singapore Malay Muslims

NCT ID: NCT05237336

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-21
• Study Completion Date: 2023-12-30

Brief Summary

Singapore's Institute of Mental Health (IMH) identified the need for culture-based research and clinical intervention catering to the minority populations in Singapore to foster treatment sustainability and recovery. Singapore's Malay population, account for 13.5% of the population. Malays tend to delay or drop-out of psychological treatments that do not address the cultural concerns which they associate to mental illness, i.e., a spiritual disorder caused by character flaws, evil spirits, or religious negligence.

The study examines the effectiveness of Mindfulness-Based Cognitive Therapy - Integrated with Psychology of Soul (MBCT-IPS) with Singaporean Malay Muslims with psychological distress. The secondary aims are to explore their experiences and perceptions on the intervention acceptability, appropriateness, and feasibility. It may provide mental health practitioners with a treatment option that may be integrated with standard therapies.

Methods: This mixed-method, three-group randomised controlled trial recruited 80Malay Muslims with psychological distress at a psychiatric rehabilitation organisation. Participants will be randomly allocated to an MBCT-IPS experimental group, an MBCT group, or individual counselling-as-usual. MBCT-IPS is a 2+8-week group intervention that integrates the Psychology of Soul (IPS) with the standard Mindfulness-Based Cognitive Therapy (MBCT).

General Linear Model (GLM) with an intention-to-treat analysis and per-protocol approach will analyse the study. Participants' and treatment providers' qualitative experiences will be thematically analysed for the acceptability of treatment after the study.

Expected results: Overall improvements in outcome measures are expected with significant differences between groups. Qualitative experiences are hoped to be enriching and therapeutic for both participants and treatment providers, with treatment being appropriate, acceptable, and feasible.

Detailed Description

This study examines the effects of MBCT-Integrated with Psychology of Self (IPS), MBCT, and one-on-one counselling-as-usual to reduce symptoms of psychological distress, and increase positive mental health and self-compassion. The IPS combines two modules from the Islamic Religious Council of Singapore (MUIS)'s Adult Islamic Learning (ADIL) programs, the 'An Introduction to Maqasid Syariah' and 'Grief and Suffering', with Dr Abdallah Rothman's grounded theory in Islamic Psychology. The IPS sessions will include Islamic psychoeducation and exercises on purpose, acceptance, letting go, and Islamic concepts on biopsychosocial-spiritual care.

The study also examines whether the participants would consider the intervention appropriate, acceptable, and feasible. We are also interested in exploring participants' understanding and meaning of the intervention and factors contributing to intervention compliance.

Procedure:

Researchers will invite Malay Muslim adults working in the private community, social service organisations, mosques, societies, support groups or studying in higher institutions of learning/universities to participate in the study. They may also invite family and friends to take part in the research. However, participants will not be informed of the various therapies provided or whether their allocation is to the experimental or control groups.

Individuals interested in participating in this study will submit a request online on Qualtrics for researchers to contact them. The Qualtrics form will include the pre-assessment measure Depression, Anxiety, and Stress Scale (DASS-21).

To screen the participants, the researchers will interview potential participants individually online. The interview will (a) assess the participants' suitability utilising the screening questionnaire that includes items for exclusion criteria, (b) readiness for intervention, (c) and informs participants about the process and demands of the study. Informed consent approved by the Agency for Integrated Care (AIC) Institutional Review Board (IRB) will be verbally obtained during the interview. Participants who agree to commit to all the assessment sessions and consent to sessions be recorded will receive the registration link. The online registration form includes a consent form, the participant's demographic information, the 19-item Positive Mental Health (PMH-19), and 12-item Self-Compassion Scale-Short Form (SCS-SF).

Assessments will be conducted on Qualtrics at five points: pre-intervention, fourth week, last session, and follow-up at 1-month & 3-months.

Those who meet the exclusion criteria and are unsuitable for MBCT will be referred to other programs at Club HEAL. Participants may withdraw from intervention at any point before or during intervention and will be contacted for their feedback. Participants who complete the assessments receive honorariums. All participants will be offered the most effective intervention at the end of the study.

Randomisation:

When participants submit their online registration, they will be randomly assigned to an intervention arm. Participants will receive their assignment and schedule via the Qualtrics email distribution.

Conditions

Psychological Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MBCT-IPS

Mindfulness-based Cognitive Therapy (MBCT) integrated with cultural Psychology of Soul (IPS) 2-session (IPS) + standard 8-session (MBCT)

Group Type: EXPERIMENTAL

Mindfulness-based Cognitive Therapy

Intervention Type: BEHAVIORAL

MBCT is a relapse prevention program that is used to teach participants with chronic physical/mental ailment (used to their conditions):

• to manage early signs of distresses with compassionate awareness, and respond more effectively to mood and cognitive changes.
• To become aware of bodily sensations, feelings, and thoughts, from moment to moment.
• To help participants learn different ways of relating to sensations, thoughts and feelings- through mindful acceptance and acknowledgement of unwanted feelings and thoughts, rather than habitual, automatic, preprogrammed routines that tend to perpetuate difficulties.
• To help participants to be able to choose the most skilful response to any unpleasant thoughts, feelings or situations that they meet.

UK's NICE recommends MBCT for persons who are well and have had 3 or more episodes of depression. MBCT benefits persons whose distress is triggered by the way they process experiences.

Mindfulness-based Cognitive Therapy

Standard 8-session Mindfulness-based Cognitive Therapy (MBCT)

Group Type: ACTIVE_COMPARATOR

Mindfulness-based Cognitive Therapy

Intervention Type: BEHAVIORAL

MBCT is a relapse prevention program that is used to teach participants with chronic physical/mental ailment (used to their conditions):

• to manage early signs of distresses with compassionate awareness, and respond more effectively to mood and cognitive changes.
• To become aware of bodily sensations, feelings, and thoughts, from moment to moment.
• To help participants learn different ways of relating to sensations, thoughts and feelings- through mindful acceptance and acknowledgement of unwanted feelings and thoughts, rather than habitual, automatic, preprogrammed routines that tend to perpetuate difficulties.
• To help participants to be able to choose the most skilful response to any unpleasant thoughts, feelings or situations that they meet.

UK's NICE recommends MBCT for persons who are well and have had 3 or more episodes of depression. MBCT benefits persons whose distress is triggered by the way they process experiences.

Counselling as usual

8-session Control group

Group Type: OTHER

Counselling as usual

Intervention Type: BEHAVIORAL

Control group, Counselling as usual

Interventions

Mindfulness-based Cognitive Therapy

MBCT is a relapse prevention program that is used to teach participants with chronic physical/mental ailment (used to their conditions):

• to manage early signs of distresses with compassionate awareness, and respond more effectively to mood and cognitive changes.
• To become aware of bodily sensations, feelings, and thoughts, from moment to moment.
• To help participants learn different ways of relating to sensations, thoughts and feelings- through mindful acceptance and acknowledgement of unwanted feelings and thoughts, rather than habitual, automatic, preprogrammed routines that tend to perpetuate difficulties.
• To help participants to be able to choose the most skilful response to any unpleasant thoughts, feelings or situations that they meet.

UK's NICE recommends MBCT for persons who are well and have had 3 or more episodes of depression. MBCT benefits persons whose distress is triggered by the way they process experiences.

Intervention Type: BEHAVIORAL

Counselling as usual

Control group, Counselling as usual

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Must be Malay Muslim, identifying with the Malay race,

2. can speak and understand English,

3. scoring Global Assessment of Functioning (GAF > 61)

4. scoring Mild to Extremely Severe in DASS-21, for at least one subscale of Depression: 5-21; Anxiety: 4-21; Or Stress: 8-21

Exclusion Criteria

1. a diagnosed mental disorder (schizophrenia, bipolar disorder, & post-traumatic stress disorder or any other mental disorders )

2. psychotic symptoms

3. actively suicidal.

4. personality disorder, including substance use and addiction.

5. neurocognitive disorders or cognitive impairment.

6. persons who have previously undergone structured MBCT treatment or concurrently receiving psychological treatment elsewhere.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Islamic University Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Jamilah Hanum Abdul Khaiyom, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jamilah H Abdul Khaiyom, PhD

Role: PRINCIPAL_INVESTIGATOR

International Islamic University Malaysia

Locations

PERGAS

Singapore, , Singapore

Club HEAL

Singapore, , Singapore

Countries

Singapore

References

Grensman A, Acharya BD, Wandell P, Nilsson GH, Falkenberg T, Sundin O, Werner S. Effect of traditional yoga, mindfulness-based cognitive therapy, and cognitive behavioral therapy, on health related quality of life: a randomized controlled trial on patients on sick leave because of burnout. BMC Complement Altern Med. 2018 Mar 6;18(1):80. doi: 10.1186/s12906-018-2141-9.

Reference Type: RESULT

PMID: 29510704 (View on PubMed)

Zemestani M, Fazeli Nikoo Z. Effectiveness of mindfulness-based cognitive therapy for comorbid depression and anxiety in pregnancy: a randomized controlled trial. Arch Womens Ment Health. 2020 Apr;23(2):207-214. doi: 10.1007/s00737-019-00962-8. Epub 2019 Apr 13.

Reference Type: RESULT

PMID: 30982086 (View on PubMed)

Chan SHW, Chan WWK, Chao JYW, Chan PKL. A randomized controlled trial on the comparative effectiveness of mindfulness-based cognitive therapy and health qigong-based cognitive therapy among Chinese people with depression and anxiety disorders. BMC Psychiatry. 2020 Dec 14;20(1):590. doi: 10.1186/s12888-020-02994-2.

Reference Type: RESULT

PMID: 33317481 (View on PubMed)

Other Identifiers

IREC 2021-279

Identifier Type: -

Identifier Source: org_study_id