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.
研究组 & 干预措施
Spiritual Intervention Programme
The intervention is a 8 weeks' programme. The Christianity approach as the framework for spiritual intervention includes use of Bible verses, prayer, hymns singing, sharing and caring for others (mutual support) within the group.
Through these activities, participants have opportunities to re-build and further develop their connectedness to themselves, to others, to their living, their environment, and to larger meaning and purpose.
干预措施: Christianity approach as framework for spiritual intervention (Behavioral)
Wait-list Control group
Participants recruited in the waitlist control will be initially tested to generate pre-test scores and will then tested six weeks later which is equivalent to the timespan between the pre-test and post-test for the experimental spiritual programme. In between these two testing sessions, the waitlist control group will not receive any type of spiritual intervention. For ethical reasons, following the second testing session, the participants in the waitlist group will be given the opportunity to participant in the spiritual intervention programme.
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