Spiritual Intervention for Persons With Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04631900
• Other study ID #: judyll2222
• Status: Completed
• Phase: N/A
• Start date: November 27, 2021
• Est. completion date: March 28, 2023

Study information

• Verified date: February 2024
• Source: City University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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: 1. To evaluate the effect of this spiritual intervention on reducing depressive symptoms. 2. To evaluate the effect of spiritual intervention on enhancing hope, meaning in life, self-esteem, and social support. 3. 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. 4. 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: 1. Spirituality, mental health and depression 2. Connectedness 3. Forgiving and freedom 4. Suffering and transcendence 5. Hope 6. Gratitude 7. Relapse prevention and spiritual growth 8. Wrap-up and celebration

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 28, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Christianity approach as framework for spiritual intervention
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.

Locations

Country	Name	City	State
China	City University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
City University of Hong Kong

Country where clinical trial is conducted

China, 

References & Publications (13)

Brooks, B. D., & Hirsch, J. K. (2017). State Hope Scale. In V. Zeigler-Hill & T. K. Shackelford (Eds.), Encyclopedia of Personality and Individual Differences (pp. 1-4). TN: Springer International Publishing.

Chan WC. Factor structure of the Chinese version of the Meaning in Life Questionnaire among Hong Kong Chinese caregivers. Health Soc Work. 2014 Aug;39(3):135-43. doi: 10.1093/hsw/hlu025. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. — View Citation

Li, W., Lukai, Rongjing, D., Dayi, H., & Sheng, L. (2014). GW25-e4488 The value of Chinese version GAD-7 and PHQ-9 to screen anxiety and depression in cardiovascular outpatients. JACC (Journal of the American College of Cardiology), 64(16), C222-C222. doi:10.1016/j.jacc.2014.06.1038

Mak WW, Ng IS, Wong CC. Resilience: enhancing well-being through the positive cognitive triad. J Couns Psychol. 2011 Oct;58(4):610-7. doi: 10.1037/a0025195. — View Citation

Rosenberg, M. (1965). Society and the adolescent self-image. Princeton, N.J.: Princeton University Press.

Schmitt DP, Allik J. Simultaneous administration of the Rosenberg Self-Esteem Scale in 53 nations: exploring the universal and culture-specific features of global self-esteem. J Pers Soc Psychol. 2005 Oct;89(4):623-42. doi: 10.1037/0022-3514.89.4.623. — View Citation

Smarr KL, Keefer AL. Measures of depression and depressive symptoms: Beck Depression Inventory-II (BDI-II), Center for Epidemiologic Studies Depression Scale (CES-D), Geriatric Depression Scale (GDS), Hospital Anxiety and Depression Scale (HADS), and Patient Health Questionnaire-9 (PHQ-9). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S454-66. doi: 10.1002/acr.20556. No abstract available. — View Citation

Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. J Pers Soc Psychol. 1996 Feb;70(2):321-35. doi: 10.1037//0022-3514.70.2.321. — View Citation

Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. — View Citation

Steger, M. F., Frazier, P., Oishi, S., & Kaler, M. (2006). The Meaning in Life Questionnaire: Assessing the Presence of and Search for Meaning in Life. Journal of Counseling Psychology, 53(1), 80-93. doi:10.1037/0022-0167.53.1.80

Wang Y, Wan Q, Huang Z, Huang L, Kong F. Psychometric Properties of Multi-Dimensional Scale of Perceived Social Support in Chinese Parents of Children with Cerebral Palsy. Front Psychol. 2017 Nov 21;8:2020. doi: 10.3389/fpsyg.2017.02020. eCollection 2017. — View Citation

Zimet, G. D., Dahlem, N. W., Zimet, S. G., & Farley, G. K. (1988). The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment, 52(1), 30-41. doi:10.1207/s15327752jpa5201_2Zimet, G. D., Dahlem, N. W., Zimet, S. G., & Farley, G. K. (1988). The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment, 52(1), 30-41. doi:10.1207/s15327752jpa5201_2

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in spiritual experience measured with Daily Spiritual Experience Scale (DSES)	The Daily Spiritual Experience Scale (DSES) (Underwood, 2011) is a 16-items self-reported validated questionnaire that assesses ordinary experience of the transcendence in daily life. It includes constructs such as awe, gratitude, mercy, sense of connection with the transcendent and compassionate love. It also includes measures of awareness of inspiration and a sense of deep inner peace. The first 15 items are scored with a Likert scale, from many times a day for 6 marks to never or almost never for 1 mark. The last item has only four response ranging from as close as possible for 4 mark to not close for 1 mark. The scores are summed up with higher score indicate higher level of spirituality. The reliability and validity of DSES have been tested to be satisfactory (Underwood & Teresi, 2002). It has been translated into over 40 languages. The Chinese version of DSES has been found to have the satisfactory psychometric properties (Ng, Fong, Tsui, Au-Yeung, & Law, 2009).	At baseline (T0), post at week 8 (T1) and follow-up at week 20 (T2).
Primary	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).
Primary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).