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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Change from Baseline to Depression, Anxiety, Stress Score (DASS-21) at Week 4
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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 )
- •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.
结局指标
主要结局
Change from Baseline to Depression, Anxiety, Stress Score (DASS-21) at Week 4
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Intervention Appropriateness Measure (IAM)(Week 4)
- Change from Week 4 in Feasibility of Intervention Measure (FIM) and Week 10(Week 4 and Week 10)
- Change from Week 4 in Self-Compassion Scale-Short Form (SCS-SF12) at Week 10(Week 4 and Week 10)
- Change from Week 4 in Acceptability of Intervention Measure (AIM) Week 10(Week 4 and Week 10)
- Feasibility of Intervention Measure (FIM)(Week 4)
- 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)
- 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 1-month follow-up in Positive Mental Health (PMH-19) at 3-month follow-up(1-month follow-up and 3-month follow-up)
- Self-Compassion Scale-Short Form (SCS-SF12) to Week 0(Week 0)
- Positive Mental Health (PMH-19) to Week 0(Week 0)
- Change from Week 10 in Self-Compassion Scale-Short Form (SCS-SF12) at 1-month follow-up(Week 10 and 1-month follow-up)
- Change from Baseline in Self-Compassion Scale-Short Form (SCS-SF12) to Week 4(Week 0 and Week 4)
- 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)
- Acceptability of Intervention Measure (AIM)(Week 4)
- Change from Week 4 in Intervention Appropriateness Measure (IAM) Week 10(Week 4 and Week 10)
研究者
Jamilah Hanum Abdul Khaiyom, PhD
Assistant Professor
International Islamic University Malaysia