Psychological DistressIPS-MBCTNCT05237336
Integrated Mindfulness-Based Cognitive Therapy for Singapore Malay Muslims
A study testing Mindfulness-based Cognitive Therapy and Counselling as usual in people with Psychological Distress, run by International Islamic University Malaysia at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- What is being tested?
- Mindfulness-based Cognitive Therapy and Counselling as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSingapore
- Study dates
- 21 Jul 2022to 30 Dec 2023
- 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 21 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be Malay Muslim, identifying with the Malay race,
- can speak and understand English,
- scoring Global Assessment of Functioning (GAF > 61)
- 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:
- a diagnosed mental disorder (schizophrenia, bipolar disorder, \& post-traumatic stress disorder or any other mental disorders )
Show all 11Show fewer
- psychotic symptoms
- actively suicidal.
- personality disorder, including substance use and addiction.
- neurocognitive disorders or cognitive impairment.
- persons who have previously undergone structured MBCT treatment or concurrently receiving psychological treatment elsewhere.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read more
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.
Read the 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
- Being tested
- Mindfulness-based Cognitive Therapy, Counselling as usual
- Keywords
- MBCT, Culture, RCT, Islamic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Cognitive TherapyBehavioural
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 usualBehavioural
Control group, Counselling as usual
| Study group | Role | What they receive |
|---|---|---|
| MBCT-IPS | Experimental | Mindfulness-based Cognitive Therapy (MBCT) integrated with cultural Psychology of Soul (IPS) 2-session (IPS) + standard 8-session (MBCT) Receives: Behavioral: Mindfulness-based Cognitive Therapy |
| Mindfulness-based Cognitive Therapy | Active comparator | Standard 8-session Mindfulness-based Cognitive Therapy (MBCT) Receives: Behavioral: Mindfulness-based Cognitive Therapy |
| Counselling as usual | Other | 8-session Control group Receives: Behavioral: Counselling as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, Anxiety, Stress Score (DASS-21) at 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
Measured: Week 0
Change from Baseline to Depression, Anxiety, Stress Score (DASS-21) at 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
Measured: Week 0 and Week 4
Change from Week 4 in Depression, Anxiety, Stress Score (DASS-21) 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
Measured: Week 4 and Week 8
Change from Week 4 in Depression, Anxiety, Stress Score (DASS-21) 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
Measured: Week 4 and Week 10
Change from Week 10 in Depression, Anxiety, Stress Score (DASS-21) at 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
Measured: Week 10 and 1-month follow-up
Change from 1-month follow-up in Depression, Anxiety, Stress Score (DASS-21) at 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
Measured: 1-month follow-up and 3-month follow-up
Secondary outcomes (17)
Positive Mental Health (PMH-19) to 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.
Measured: Week 0
Change from Baseline in Positive Mental Health (PMH-19) to 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.
Measured: Week 0 and Week 4
Change from Week 4 in Positive Mental Health (PMH-19) 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.
Measured: Week 4 up to Week 8
Change from Week 4 in Positive Mental Health (PMH-19) 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.
Measured: Week 4 up to Week 10
Change from Week 10 in Positive Mental Health (PMH-19) at 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.
Measured: Week 10 and 1-month follow-up
Change from 1-month follow-up in Positive Mental Health (PMH-19) at 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.
Measured: 1-month follow-up and 3-month follow-up
Self-Compassion Scale-Short Form (SCS-SF12) to 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.
Measured: Week 0
Change from Baseline in Self-Compassion Scale-Short Form (SCS-SF12) to 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.
Measured: Week 0 and Week 4
Change from Week 4 in Self-Compassion Scale-Short Form (SCS-SF12) at 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.
Measured: Week 4 and Week 10
Change from Week 10 in Self-Compassion Scale-Short Form (SCS-SF12) at 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.
Measured: Week 10 and 1-month follow-up
Change from 1-month follow-up in Self-Compassion Scale-Short Form (SCS-SF12) at 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.
Measured: 1-month follow-up and 3-month follow-up
Acceptability of Intervention Measure (AIM)
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.
Measured: Week 4
Change from Week 4 in Acceptability of Intervention Measure (AIM) 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.
Measured: Week 4 and Week 10
Intervention Appropriateness Measure (IAM)
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.
Measured: Week 4
Change from Week 4 in Intervention Appropriateness Measure (IAM) 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.
Measured: Week 4 and Week 10
Feasibility of Intervention Measure (FIM)
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.
Measured: Week 4
Change from Week 4 in Feasibility of Intervention Measure (FIM) 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.
Measured: Week 4 and Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start21 Jul 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Islamic University Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamilah Hanum Abdul Khaiyom, PhD, International Islamic University Malaysia
- Investigators
- Jamilah H Abdul Khaiyom, PhD, Principal investigator, International Islamic University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237336
- Sponsor's protocol ID
- IREC 2021-279
- Acronym
- IPS-MBCT
- Status last verified
- Mar 2024
- First submitted
- 11 Jan 2022
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29510704Zemestani 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.
PubMed 30982086Chan 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.
PubMed 33317481
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05237336
- Acronym / sponsor ID
- IPS-MBCT / IREC 2021-279
- Conditions
- Psychological Distress
- Keywords
- MBCT, Culture, RCT, Islamic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- International Islamic University MalaysiaUniversity, hospital or other
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 14 Feb 2022 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| MBCT-IPS | Experimental | Behavioral: Mindfulness-based Cognitive TherapyMindfulness-based Cognitive Therapy (MBCT) integrated with cultural Psychology of Soul (IPS) 2-session (IPS) + standard 8-session (MBCT) |
| Mindfulness-based Cognitive Therapy | Active comparator | Behavioral: Mindfulness-based Cognitive TherapyStandard 8-session Mindfulness-based Cognitive Therapy (MBCT) |
| Counselling as usual | Other | Behavioral: Counselling as usual8-session Control group |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Must be Malay Muslim, identifying with the Malay race,
- can speak and understand English,
- scoring Global Assessment of Functioning (GAF > 61)
- 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:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Mindfulness-based Cognitive TherapyMBCT 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. | Behavioural | MBCT-IPS, Mindfulness-based Cognitive Therapy |
| Counselling as usualControl group, Counselling as usual | Behavioural | Counselling as usual |
Primary outcome
Depression, Anxiety, Stress Score (DASS-21) at Week 0
Time frame: 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 Baseline to Depression, Anxiety, Stress Score (DASS-21) at Week 4
Time frame: 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 Week 4 in Depression, Anxiety, Stress Score (DASS-21) and Week 8
Time frame: 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
Time frame: 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
Time frame: 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
Change from 1-month follow-up in Depression, Anxiety, Stress Score (DASS-21) at 3-month follow-up
Time frame: 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
17 secondary outcomes
Positive Mental Health (PMH-19) to Week 0
Time frame: Week 0
Change from Baseline in Positive Mental Health (PMH-19) to Week 4
Time frame: Week 0 and Week 4
Change from Week 4 in Positive Mental Health (PMH-19) up to Week 8
Time frame: Week 4 up to Week 8
Change from Week 4 in Positive Mental Health (PMH-19) up to Week 10
Time frame: Week 4 up to Week 10
Change from Week 10 in Positive Mental Health (PMH-19) at 1-month follow-up
Time frame: Week 10 and 1-month follow-up
Change from 1-month follow-up in Positive Mental Health (PMH-19) at 3-month follow-up
Time frame: 1-month follow-up and 3-month follow-up
Self-Compassion Scale-Short Form (SCS-SF12) to Week 0
Time frame: Week 0
Change from Baseline in Self-Compassion Scale-Short Form (SCS-SF12) to Week 4
Time frame: Week 0 and Week 4
Change from Week 4 in Self-Compassion Scale-Short Form (SCS-SF12) at Week 10
Time frame: Week 4 and Week 10
Change from Week 10 in Self-Compassion Scale-Short Form (SCS-SF12) at 1-month follow-up
Time frame: Week 10 and 1-month follow-up
Change from 1-month follow-up in Self-Compassion Scale-Short Form (SCS-SF12) at 3-month follow-up
Time frame: 1-month follow-up and 3-month follow-up
Acceptability of Intervention Measure (AIM)
Time frame: Week 4
Change from Week 4 in Acceptability of Intervention Measure (AIM) Week 10
Time frame: Week 4 and Week 10
Intervention Appropriateness Measure (IAM)
Time frame: Week 4
Change from Week 4 in Intervention Appropriateness Measure (IAM) Week 10
Time frame: Week 4 and Week 10
Feasibility of Intervention Measure (FIM)
Time frame: Week 4
Change from Week 4 in Feasibility of Intervention Measure (FIM) and Week 10
Time frame: Week 4 and Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Results publication: PubMed 29510704Grensman 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.
- Results publication: PubMed 30982086Zemestani 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.
- Results publication: PubMed 33317481Chan 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.
- 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 H Abdul Khaiyom, PhD principal investigator
International Islamic University Malaysia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Cognitive Therapy and Counselling as usual in people with Psychological Distress, run by International Islamic University Malaysia at 2 sites in Singapore.
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 11 inclusion and 0 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: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depression, Anxiety, Stress Score (DASS-21) at Week 0 (time frame: Week 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05237336, which also lists 3 linked publications.
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 7 Mar 2024.