Integrated Mindfulness-Based Cognitive Therapy for Singapore Malay Muslims

NCT05237336 | Completed DMC

• 1 other identifier: IREC 2021-279
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Psychological Distress

Keywords

MBCT; Culture; RCT; Islamic

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  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

  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

  1-month follow-up and 3-month follow-up

Secondary Outcomes (17)

• Positive Mental Health (PMH-19) to Week 0

  Week 0

• Change from Baseline in Positive Mental Health (PMH-19) to Week 4

  Week 0 and Week 4

• Change from Week 4 in Positive Mental Health (PMH-19) up to Week 8

  Week 4 up to Week 8

• Change from Week 4 in Positive Mental Health (PMH-19) up to Week 10

  Week 4 up to Week 10

• Change from Week 10 in Positive Mental Health (PMH-19) at 1-month follow-up

  Week 10 and 1-month follow-up

Other Outcomes (1)

• Focus Group Discussions (FGD)

  3-month post-intervention

Study Arms (3)

MBCT-IPS

EXPERIMENTAL

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

Behavioral: Mindfulness-based Cognitive Therapy

Mindfulness-based Cognitive Therapy

ACTIVE COMPARATOR

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

Behavioral: Mindfulness-based Cognitive Therapy

Counselling as usual

OTHER

8-session Control group

Behavioral: Counselling as usual

Interventions

Mindfulness-based Cognitive Therapy 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.

MBCT-IPS; Mindfulness-based Cognitive Therapy

Counselling as usual BEHAVIORAL

Control group, Counselling as usual

Counselling as usual

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• International Islamic University Malaysia: lead

Study Sites (2)

PERGAS

Singapore, 419975, Singapore

Location

Club HEAL

Singapore, 650254, Singapore

Location

Related Publications (3)

• 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.

  PMID: 29510704 RESULT

• 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.

  PMID: 30982086 RESULT

• 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.

  PMID: 33317481 RESULT

MeSH Terms

Interventions

Mindfulness-Based Cognitive Therapy; Counseling

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mental Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jamilah H Abdul Khaiyom, PhD

  International Islamic University Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 14, 2022
• Study Start: July 21, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)