Integrated Mindfulness-Based Cognitive Therapy for Singapore Malay Muslims

Not Applicable

Completed

• Conditions: Psychological Distress
• Interventions: Behavioral: Counselling as usual; Behavioral: Mindfulness-based Cognitive Therapy

• Registration Number: NCT05237336
• Lead Sponsor: International Islamic University Malaysia

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.

Study Timeline

• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-14
• Study Start: 2022-07-21
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Counselling as usual	Counselling as usual	8-session Control group
MBCT-IPS	Mindfulness-based Cognitive Therapy	Mindfulness-based Cognitive Therapy (MBCT) integrated with cultural Psychology of Soul (IPS) 2-session (IPS) + standard 8-session (MBCT)
Mindfulness-based Cognitive Therapy	Mindfulness-based Cognitive Therapy	Standard 8-session Mindfulness-based Cognitive Therapy (MBCT)

Primary Outcome Measures

Name	Time	Method
Change from Baseline to Depression, Anxiety, Stress Score (DASS-21) at Week 4	Week 0 and Week 4	DASS-21 has twenty-one questions, and is a self-administered survey, measuring core symptoms associated with depression, anxiety, and stress on a four-point Likert scale to indicate each symptom's frequency and intensity for the past week. Ratings begin at 0 as "Never" to 3 for "Almost Always". Depression is interpreted as "normal" when the score is between 0-4, mild at 5-6, moderate at 7-10, severe at 11-13 and extremely severe at 14+. Anxiety is categorised as normal between 0-3, mild at 4-5, moderate at 6-7, severe at 8-9 and extremely severe at 10 or more. Stress is indicated as "normal" between 0-7, "mild" at 8-9, "moderate" at 10-12, severe at 13-16 and extremely severe at 17 or more
Change from 1-month follow-up in Depression, Anxiety, Stress Score (DASS-21) at 3-month follow-up	1-month follow-up and 3-month follow-up	DASS-21 has twenty-one questions, and is a self-administered survey, measuring core symptoms associated with depression, anxiety, and stress on a four-point Likert scale to indicate each symptom's frequency and intensity for the past week. Ratings begin at 0 as "Never" to 3 for "Almost Always". Depression is interpreted as "normal" when the score is between 0-4, mild at 5-6, moderate at 7-10, severe at 11-13 and extremely severe at 14+. Anxiety is categorised as normal between 0-3, mild at 4-5, moderate at 6-7, severe at 8-9 and extremely severe at 10 or more. Stress is indicated as "normal" between 0-7, "mild" at 8-9, "moderate" at 10-12, severe at 13-16 and extremely severe at 17 or more
Depression, Anxiety, Stress Score (DASS-21) at Week 0	Week 0	DASS-21 has twenty-one questions, and is a self-administered survey, measuring core symptoms associated with depression, anxiety, and stress on a four-point Likert scale to indicate each symptom's frequency and intensity for the past week. Ratings begin at 0 as "Never" to 3 for "Almost Always". Depression is interpreted as "normal" when the score is between 0-4, mild at 5-6, moderate at 7-10, severe at 11-13 and extremely severe at 14+. Anxiety is categorised as normal between 0-3, mild at 4-5, moderate at 6-7, severe at 8-9 and extremely severe at 10 or more. Stress is indicated as "normal" between 0-7, "mild" at 8-9, "moderate" at 10-12, severe at 13-16 and extremely severe at 17 or more
Change from Week 4 in Depression, Anxiety, Stress Score (DASS-21) and Week 8	Week 4 and Week 8	DASS-21 has twenty-one questions, and is a self-administered survey, measuring core symptoms associated with depression, anxiety, and stress on a four-point Likert scale to indicate each symptom's frequency and intensity for the past week. Ratings begin at 0 as "Never" to 3 for "Almost Always". Depression is interpreted as "normal" when the score is between 0-4, mild at 5-6, moderate at 7-10, severe at 11-13 and extremely severe at 14+. Anxiety is categorised as normal between 0-3, mild at 4-5, moderate at 6-7, severe at 8-9 and extremely severe at 10 or more. Stress is indicated as "normal" between 0-7, "mild" at 8-9, "moderate" at 10-12, severe at 13-16 and extremely severe at 17 or more
Change from Week 4 in Depression, Anxiety, Stress Score (DASS-21) and Week 10	Week 4 and Week 10	DASS-21 has twenty-one questions, and is a self-administered survey, measuring core symptoms associated with depression, anxiety, and stress on a four-point Likert scale to indicate each symptom's frequency and intensity for the past week. Ratings begin at 0 as "Never" to 3 for "Almost Always". Depression is interpreted as "normal" when the score is between 0-4, mild at 5-6, moderate at 7-10, severe at 11-13 and extremely severe at 14+. Anxiety is categorised as normal between 0-3, mild at 4-5, moderate at 6-7, severe at 8-9 and extremely severe at 10 or more. Stress is indicated as "normal" between 0-7, "mild" at 8-9, "moderate" at 10-12, severe at 13-16 and extremely severe at 17 or more
Change from Week 10 in Depression, Anxiety, Stress Score (DASS-21) at 1-month follow-up	Week 10 and 1-month follow-up	DASS-21 has twenty-one questions, and is a self-administered survey, measuring core symptoms associated with depression, anxiety, and stress on a four-point Likert scale to indicate each symptom's frequency and intensity for the past week. Ratings begin at 0 as "Never" to 3 for "Almost Always". Depression is interpreted as "normal" when the score is between 0-4, mild at 5-6, moderate at 7-10, severe at 11-13 and extremely severe at 14+. Anxiety is categorised as normal between 0-3, mild at 4-5, moderate at 6-7, severe at 8-9 and extremely severe at 10 or more. Stress is indicated as "normal" between 0-7, "mild" at 8-9, "moderate" at 10-12, severe at 13-16 and extremely severe at 17 or more

Secondary Outcome Measures

Name	Time	Method
Intervention Appropriateness Measure (IAM)	Week 4	4-item psychometric measure used to assess perceived appropriateness. Participants indicate on the five-point Likert scale from "Completely Disagree" to "Completely Agree". The score is calculated by averaging the response.
Change from Week 4 in Feasibility of Intervention Measure (FIM) and Week 10	Week 4 and Week 10	4-item psychometric measure used to assess perceived feasibility of treatment. Participants indicate on the five-point Likert scale from "Completely Disagree" to "Completely Agree". The score is calculated by averaging the response.
Feasibility of Intervention Measure (FIM)	Week 4	4-item psychometric measure used to assess perceived feasibility of treatment. Participants indicate on the five-point Likert scale from "Completely Disagree" to "Completely Agree". The score is calculated by averaging the response.
Change from Week 4 in Self-Compassion Scale-Short Form (SCS-SF12) at Week 10	Week 4 and Week 10	12-item measure, six domains: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. There are 2-items for each domain. Participants indicate on each item, in response to, "How I typically act towards myself in difficult times", from the 5-point Likert scale ranging from 1 being "almost never" to 5 being "almost always". subscales calculate scores to identify domains to improve. An overall score will also be calculated, with the average score being three and the cut off being five.; In the domains of self-judgment, isolation, and over-identification, scores higher than 3 indicates lesser self-compassion. In self-kindness, common humanity and mindfulness, scores above 3 indicate higher self-compassion.
Change from Week 4 in Acceptability of Intervention Measure (AIM) Week 10	Week 4 and Week 10	4-item psychometric measure used to assess perceived acceptability. Participants indicate on the five-point Likert scale from "Completely Disagree" to "Completely Agree". The score is calculated by averaging the response.
Change from Week 4 in Positive Mental Health (PMH-19) up to Week 10	Week 4 up to Week 10	This 19-item instrument was developed and tested by the IMH research team to assess the six dimensions of positive mental health in Singapore's multi-ethnic population. subscales consist of General Coping (2-items), Emotional support (3-items), Spirituality (4-items), Interpersonal skills (3-items), Personal Growth \& Autonomy (4-items), Global affect (3-items). Participants will select on a scale of 1 (not at all like me) to 6 (exactly like me) for the first five subscales. On the 6th subscale, participants indicate how frequently they felt over the past month on a five-point response scale. Scores are added over each subscale and divided by the number of items in that subscale. Higher subscale scores indicate a higher PMH.
Change from Week 10 in Positive Mental Health (PMH-19) at 1-month follow-up	Week 10 and 1-month follow-up	This 19-item instrument was developed and tested by the IMH research team to assess the six dimensions of positive mental health in Singapore's multi-ethnic population. subscales consist of General Coping (2-items), Emotional support (3-items), Spirituality (4-items), Interpersonal skills (3-items), Personal Growth \& Autonomy (4-items), Global affect (3-items). Participants will select on a scale of 1 (not at all like me) to 6 (exactly like me) for the first five subscales. On the 6th subscale, participants indicate how frequently they felt over the past month on a five-point response scale. Scores are added over each subscale and divided by the number of items in that subscale. Higher subscale scores indicate a higher PMH.
Change from Baseline in Positive Mental Health (PMH-19) to Week 4	Week 0 and Week 4	This 19-item instrument was developed and tested by the IMH research team to assess the six dimensions of positive mental health in Singapore's multi-ethnic population. subscales consist of General Coping (2-items), Emotional support (3-items), Spirituality (4-items), Interpersonal skills (3-items), Personal Growth \& Autonomy (4-items), Global affect (3-items). Participants will select on a scale of 1 (not at all like me) to 6 (exactly like me) for the first five subscales. On the 6th subscale, participants indicate how frequently they felt over the past month on a five-point response scale. Scores are added over each subscale and divided by the number of items in that subscale. Higher subscale scores indicate a higher PMH.
Change from Week 4 in Positive Mental Health (PMH-19) up to Week 8	Week 4 up to Week 8	This 19-item instrument was developed and tested by the IMH research team to assess the six dimensions of positive mental health in Singapore's multi-ethnic population. subscales consist of General Coping (2-items), Emotional support (3-items), Spirituality (4-items), Interpersonal skills (3-items), Personal Growth \& Autonomy (4-items), Global affect (3-items). Participants will select on a scale of 1 (not at all like me) to 6 (exactly like me) for the first five subscales. On the 6th subscale, participants indicate how frequently they felt over the past month on a five-point response scale. Scores are added over each subscale and divided by the number of items in that subscale. Higher subscale scores indicate a higher PMH.
Change from 1-month follow-up in Positive Mental Health (PMH-19) at 3-month follow-up	1-month follow-up and 3-month follow-up	This 19-item instrument was developed and tested by the IMH research team to assess the six dimensions of positive mental health in Singapore's multi-ethnic population. subscales consist of General Coping (2-items), Emotional support (3-items), Spirituality (4-items), Interpersonal skills (3-items), Personal Growth \& Autonomy (4-items), Global affect (3-items). Participants will select on a scale of 1 (not at all like me) to 6 (exactly like me) for the first five subscales. On the 6th subscale, participants indicate how frequently they felt over the past month on a five-point response scale. Scores are added over each subscale and divided by the number of items in that subscale. Higher subscale scores indicate a higher PMH.
Self-Compassion Scale-Short Form (SCS-SF12) to Week 0	Week 0	12-item measure, six domains: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. There are 2-items for each domain. Participants indicate on each item, in response to, "How I typically act towards myself in difficult times", from the 5-point Likert scale ranging from 1 being "almost never" to 5 being "almost always". subscales calculate scores to identify domains to improve. An overall score will also be calculated, with the average score being three and the cut off being five.; In the domains of self-judgment, isolation, and over-identification, scores higher than 3 indicates lesser self-compassion. In self-kindness, common humanity and mindfulness, scores above 3 indicate higher self-compassion.
Positive Mental Health (PMH-19) to Week 0	Week 0	This 19-item instrument was developed and tested by the IMH research team to assess the six dimensions of positive mental health in Singapore's multi-ethnic population. subscales consist of General Coping (2-items), Emotional support (3-items), Spirituality (4-items), Interpersonal skills (3-items), Personal Growth \& Autonomy (4-items), Global affect (3-items). Participants will select on a scale of 1 (not at all like me) to 6 (exactly like me) for the first five subscales. On the 6th subscale, participants indicate how frequently they felt over the past month on a five-point response scale. Scores are added over each subscale and divided by the number of items in that subscale. Higher subscale scores indicate a higher PMH.
Change from Week 10 in Self-Compassion Scale-Short Form (SCS-SF12) at 1-month follow-up	Week 10 and 1-month follow-up	12-item measure, six domains: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. There are 2-items for each domain. Participants indicate on each item, in response to, "How I typically act towards myself in difficult times", from the 5-point Likert scale ranging from 1 being "almost never" to 5 being "almost always". subscales calculate scores to identify domains to improve. An overall score will also be calculated, with the average score being three and the cut off being five.; In the domains of self-judgment, isolation, and over-identification, scores higher than 3 indicates lesser self-compassion. In self-kindness, common humanity and mindfulness, scores above 3 indicate higher self-compassion.
Change from Baseline in Self-Compassion Scale-Short Form (SCS-SF12) to Week 4	Week 0 and Week 4	12-item measure, six domains: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. There are 2-items for each domain. Participants indicate on each item, in response to, "How I typically act towards myself in difficult times", from the 5-point Likert scale ranging from 1 being "almost never" to 5 being "almost always". subscales calculate scores to identify domains to improve. An overall score will also be calculated, with the average score being three and the cut off being five.; In the domains of self-judgment, isolation, and over-identification, scores higher than 3 indicates lesser self-compassion. In self-kindness, common humanity and mindfulness, scores above 3 indicate higher self-compassion.
Change from 1-month follow-up in Self-Compassion Scale-Short Form (SCS-SF12) at 3-month follow-up	1-month follow-up and 3-month follow-up	12-item measure, six domains: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. There are 2-items for each domain. Participants indicate on each item, in response to, "How I typically act towards myself in difficult times", from the 5-point Likert scale ranging from 1 being "almost never" to 5 being "almost always". subscales calculate scores to identify domains to improve. An overall score will also be calculated, with the average score being three and the cut off being five.; In the domains of self-judgment, isolation, and over-identification, scores higher than 3 indicates lesser self-compassion. In self-kindness, common humanity and mindfulness, scores above 3 indicate higher self-compassion.
Acceptability of Intervention Measure (AIM)	Week 4	4-item psychometric measure used to assess perceived acceptability. Participants indicate on the five-point Likert scale from "Completely Disagree" to "Completely Agree". The score is calculated by averaging the response.
Change from Week 4 in Intervention Appropriateness Measure (IAM) Week 10	Week 4 and Week 10	4-item psychometric measure used to assess perceived appropriateness. Participants indicate on the five-point Likert scale from "Completely Disagree" to "Completely Agree". The score is calculated by averaging the response.

Trial Locations

Locations (2)

PERGAS; 🇸🇬 Singapore, Singapore

Club HEAL; 🇸🇬 Singapore, Singapore