Clinical trial NCT05237336: Integrated Mindfulness-Based Cognitive Therapy for Singapore Malay Muslims
Official title: Integrating Psychology of the Soul With Mindfulness-Based Cognitive Therapy for Singapore's Malay Muslims With Psychological Distress: A Mixed-Method Study for Effectiveness and Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Keywords: MBCT
Culture
RCT
Islamic
Lead sponsor: International Islamic University Malaysia
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This three-group randomised controlled trial recruited 80 Malay Muslims with psychological distress. Participants will be randomly allocated to an MBCT-IPS experimental group, an MBCT group, or individual counselling-as-usual.
Primary purpose: TREATMENT

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.

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: Patients (whether inpatient or outpatient) or individuals who report having:

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.

Primary outcomes:
measure: Depression, Anxiety, Stress Score (DASS-21) at Week 0
timeFrame: Week 0
measure: Change from Baseline to Depression, Anxiety, Stress Score (DASS-21) at Week 4
timeFrame: Week 0 and Week 4
measure: Change from Week 4 in Depression, Anxiety, Stress Score (DASS-21) and Week 8
timeFrame: Week 4 and Week 8
measure: Change from Week 4 in Depression, Anxiety, Stress Score (DASS-21) and Week 10
timeFrame: Week 4 and Week 10
measure: Change from Week 10 in Depression, Anxiety, Stress Score (DASS-21) at 1-month follow-up
timeFrame: Week 10 and 1-month follow-up
measure: Change from 1-month follow-up in Depression, Anxiety, Stress Score (DASS-21) at 3-month follow-up
timeFrame: 1-month follow-up and 3-month follow-up
Secondary outcomes:
measure: Positive Mental Health (PMH-19) to Week 0
timeFrame: Week 0
measure: Change from Baseline in Positive Mental Health (PMH-19) to Week 4
timeFrame: Week 0 and Week 4
measure: Change from Week 4 in Positive Mental Health (PMH-19) up to Week 8
timeFrame: Week 4 up to Week 8
measure: Change from Week 4 in Positive Mental Health (PMH-19) up to Week 10
timeFrame: Week 4 up to Week 10
measure: Change from Week 10 in Positive Mental Health (PMH-19) at 1-month follow-up
timeFrame: Week 10 and 1-month follow-up
measure: Change from 1-month follow-up in Positive Mental Health (PMH-19) at 3-month follow-up
timeFrame: 1-month follow-up and 3-month follow-up
measure: Self-Compassion Scale-Short Form (SCS-SF12) to Week 0
timeFrame: Week 0
measure: Change from Baseline in Self-Compassion Scale-Short Form (SCS-SF12) to Week 4
timeFrame: Week 0 and Week 4
measure: Change from Week 4 in Self-Compassion Scale-Short Form (SCS-SF12) at Week 10
timeFrame: Week 4 and Week 10
measure: Change from Week 10 in Self-Compassion Scale-Short Form (SCS-SF12) at 1-month follow-up
timeFrame: Week 10 and 1-month follow-up
measure: Change from 1-month follow-up in Self-Compassion Scale-Short Form (SCS-SF12) at 3-month follow-up
timeFrame: 1-month follow-up and 3-month follow-up
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Week 4
measure: Change from Week 4 in Acceptability of Intervention Measure (AIM) Week 10
timeFrame: Week 4 and Week 10
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Week 4
measure: Change from Week 4 in Intervention Appropriateness Measure (IAM) Week 10
timeFrame: Week 4 and Week 10
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Week 4
measure: Change from Week 4 in Feasibility of Intervention Measure (FIM) and Week 10
timeFrame: Week 4 and Week 10
Other outcomes:
measure: Focus Group Discussions (FGD)
timeFrame: 3-month post-intervention
Locations:
city: Singapore
country: Singapore
facility: PERGAS
city: Singapore
country: Singapore
facility: Club HEAL
Study officials:
affiliation: International Islamic University Malaysia
name: Jamilah H Abdul Khaiyom, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.