Spiritual Intervention for Persons With Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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 compare the responses to intervention across different subgroups by age, sex, and severity of symptoms. 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: Spirituality, mental health and depression Connectedness Forgiving and freedom Suffering and transcendence Hope Gratitude Relapse prevention and spiritual growth Wrap-up and celebration

Official Title
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Effect of a Community-oriented Spiritual Intervention Programme in Persons With Depression: a Randomized Wait-list Control Trial

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Christianity approach as framework for spiritual intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spiritual Intervention Programme<br>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. | Behavioral: Christianity approach as framework for spiritual intervention<br>* 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.<br>|
| No Intervention: Wait-list Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression measured with Patient Health Questionnaire-9 (PHQ-9) score | 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). | At baseline (T0), post at week 8 (T1) and follow-up at week 20 (T2). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety measured with General Anxiety Disorder Questionnaire (GAD-7) | 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). | 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 State Hope Scale (SHS) ( Snyder et al., 1996) is a 6 items self-reported instrument for measuring the extent of hope individuals held toward ongoing events in their lives. It is an 8-point Likert scale, with 1 (definitely false) to 8 (definitely true), with odd-number items measuring pathway thinking and even number items measuring agency thinking. Scores can range from 6 to 48, with higher scores representing higher hope levels.. C. R. Snyder et al. (1996) reported that SHS was a reliable and valid measure of state hope, with factor analyses confirming the two factors of agency and pathways. The internal consistency values ranging from 0.90 to 0.95 for both the agency and pathways subscale, and all adaptations and translations of the scale are reported to retain the high internal consistency (Brooks & Hirsch, 2017). The Chinese version is available (Mak, Ng, & Wong, 2011). | 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 meaning and purpose in life measured with Meaning in Life Questionnaire (MLQ) | The Meaning in Life Questionnaire (MLQ) (Steger, Frazier, Oishi, & Kaler, 2006) is a 10 items questionnaire. It measures 2 subscales of the presence of meaning in life and the search for meaning in life. It is a 7-point Likert scale from 1 (absolutely true) to 7 (absolutely untrue). 5 items are for presence of meaning and 5 for search for meaning. Items are summed yielding a range from 5 to 35 for each subscale with higher scores indicates a strong presence of/search for meaning in one's life. It has been translated into over two dozen languages. The Chinese version of the questionnaire has the same factor structure as the original version of MLQ among the caregivers in Hong Kong (Chan, 2014). | At baseline (T0), post at week 8 (T1) and follow-up at week 20 (T2). | 
| Change in self-esteem measured with Rosenberg Self-Esteem Scale (RSES) | The Rosenberg Self-Esteem Scale (RSES) (Rosenberg, 1965) is a widely used instrument (10 items) around the world for measuring self-esteem with a 4 point Likert scale ranging from ranging from 4 (strong agree) to 1 (strong disagree). Reverse scoring (4= strongly disagree to 1= strongly agree are used for five negatively worded items: 2, 5, 6, 8 and 9. The total score ranges from 10 to 40 with higher scores indicates higher self-esteem. The internal reliability and factor structure of the scale is psychometrically sound across many languages and cultures (Schmitt & Allik, 2005). | 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) | The Multidimensional Scale of Perceived Social Support (MSPSS) (Zimet, Dahlem, Zimet, & Farley, 1988) is one of the most extensively used instruments to assess social support. It is a 12 items self -administered measure of social support with 3 subscales of family, friends, and significant others. It is a 7 point Likert scale ranging from 1(very strongly disagree ) to 7 (very strongly agree). The mean scores for significant other subscale is the sum across items 1, 2, 5 & 10, then divided by 4; the mean scores for family subscale is the sum across items 3,4, 8, & 11, then divided by 4; the mean scores of friends subscale is the sum across items 6, 7, 9, &b 12, then divided by 4. The mean score of the total scale is the sum across all 12 items, then divided by 12. The mean score range from 1 (lowest) to 7 (highest). The Chinese version of MSPSS has good internal consistency reliability with composite reliability values of more than 0.7 (Y. Wang, Wan, Huang, Huang, & Kong, 2017). | At baseline (T0), post at week 8 (T1) and follow-up at week 20 (T2). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Spiritual intervention, Christian, Connectedness, randomized wait-list, community