Spiritual Intervention for Persons With Depression

NCT04631900 | Completed

• 1 other identifier: judyll2222
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

Spiritual intervention; Depression; Christian; Connectedness; randomized wait-list; community

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (4)

• 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 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 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).

Other Outcomes (1)

• Change in spiritual experience measured with Daily Spiritual Experience Scale (DSES)

  At baseline (T0), post at week 8 (T1) and follow-up at week 20 (T2).

Study Arms (2)

Spiritual Intervention Programme

EXPERIMENTAL

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

Wait-list Control group

NO INTERVENTION

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.

Interventions

Christianity approach as framework for spiritual intervention BEHAVIORAL

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.

Spiritual Intervention Programme

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• City University of Hong Kong: lead

Study Sites (1)

City University of Hong Kong

Hong Kong, China

Location

Related Publications (13)

• 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.

  PMID: 25095626 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 21895357 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 16287423 BACKGROUND

• 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.

  PMID: 22588766 BACKGROUND

• 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.

  PMID: 8636885 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 29209254 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Judy LF LEUNG, PhD(c)

  City University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 17, 2020
• Study Start: November 27, 2021
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The completion of the data collection should be finished by Dec 2021 and time frame of sharing individual participant data (IPD) should be by Dec 2022.
• Access Criteria: It is hoped that the result can be disseminated via seminars, conference presentations and various media. The actual website is not available at the moment.

Locations

CN (1)