Effect of a Community-oriented Spiritual Intervention Programme in Persons With Depression: a Randomized Wait-list Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Change in depression measured with Patient Health Questionnaire-9 (PHQ-9) score
研究概览
简要总结
Mental health is an integral part of health and depression has become a common and serious mental disorder. The research study aims to explore the effectiveness of spiritual intervention in persons with depression.
详细描述
This study aims to develop a community-oriented spiritual intervention programme that focuses on connectedness and to explore its effectiveness in persons with depression.
Objectives:
- To evaluate the effect of this spiritual intervention on reducing depressive symptoms.
- To evaluate the effect of spiritual intervention on enhancing hope, meaning in life, self-esteem, and social support.
- To examine the moderatioon effect of demographic variables on the intervention effect in reducing the depressive and anxiety symptoms, and ennhancing hope, meaning in life, self-esteem, and social support.
- To examine participant's perspectives on the healing mechanisms of the intervention.
The study is conducted as a randomized-controlled trial using a wait-list control group for comparison. The wait-list control group will receive the intervention after the completion of the post-questionnaire.
The intervention is an 8 session weekly programme. Each weekly session is around 2 hours in length and the content is as below:
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hong Kong Chinese residents who can communicate in Cantonese;
- •Religious or non-religious but have no objection to Christian faith rituals;
- •Screening by PHQ-9 with score of 5-14 out of 27; and
- •Willing to give informed consent and comply with the trial protocol.
排除标准
- •Receiving any form of psychotherapy in the past 3 months;
- •Significant cognitive impairment that is difficult to follow instructions;
- •Lifetime history of psychosis that make the person unable to understand and follow instructions;
- •Strong suicidal risk as rated by PHQ-9 item on suicide (score equal or more than 2), those with severe depression and strong suicidal ideas will be referred to seek professional help; and
- •Adjustment of medication (antidepressant) within the past 3 months.
结局指标
主要结局
Change in depression measured with Patient Health Questionnaire-9 (PHQ-9) score
时间窗: At baseline (T0), post at week 8 (T1) and follow-up at week 20 (T2).
The Patient Health Questionnaire-9 (PHQ-9) (Kroenke, Spitzer, \& Williams, 2001) is a self-reported questionnaire designed for use in primary care. It is a structured questionnaire that enquires after the nine symptom- based criteria for diagnostic criteria in the DSM-IV depression. Score can range from 0-27. Sum scores of 0-4 indicate none or minimal depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, and 15-27 severe depressive symptoms. It has been found to have good sensitivity and specificity (Kroenke et al., 2001). The Cronbach's alpha was reported to be 0.86 - 0.89 (Smarr \& Keefer, 2011).
Change in anxiety measured with General Anxiety Disorder Questionnaire (GAD-7)
时间窗: At baseline (T0), post at week 8 (T1) and follow-up at week 20 (T2).
The General Anxiety Disorder Questionnaire (GAD-7) (Spitzer, Kroenke, Williams, \& Löwe, 2006) is an easy-to-use 7 items self-administered patient questionnaire used to screen the severity measure of generalized anxiety disorder with good psychometric property. Score can range from 0-21. Sum scores of 0-5 indicates mild anxiety, 6-10 moderate anxiety, 11-15 moderately severe anxiety, and 16-21 severe anxiety. The Chinese version was tested to be a reliable and efficient instrument. (Wang Li, Lukai, Rongjing, Dayi, \& Sheng, 2014).
次要结局
- Change in meaning and purpose in life measured with Meaning in Life Questionnaire (MLQ)(At baseline (T0), post at week 8 (T1) and follow-up at week 20 (T2).)
- Change in hope measured with State Hope Scale (SHS)(The data will be collected in both experimental and wait-list control groups at three points: at baseline (T0), week 8 (T1) and week 20 (T2).)
- Change in self-esteem measured with Rosenberg Self-Esteem Scale (RSES)(At baseline (T0), post at week 6 (T1) and follow-up at week 18 (T2).)
- Change in perceived social support measured with Multidimensional Scale of Perceived Social Support (MSPSS)(At baseline (T0), post at week 8 (T1) and follow-up at week 20 (T2).)
研究者
LEUNG Lai Fun Judy
Principal Investigator
City University of Hong Kong