Skip to main content
OpenTrials
Completed

NCT Number: NCT04631900

Spiritual Intervention for Persons With Depression

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City University of Hong Kong

Hong Kong, China

About this study

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:

  • Spirituality, mental health and depression
  • Connectedness
  • Forgiving and freedom
  • Suffering and transcendence
  • Hope
  • Gratitude
  • Relapse prevention and spiritual growth
  • Wrap-up and celebration

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in depression measured with Patient Health Questionnaire-9 (PHQ-9) score

    Time frame: 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).

  2. Change in anxiety measured with General Anxiety Disorder Questionnaire (GAD-7)

    Time frame: 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).

Secondary outcomes

  1. Change in hope measured with State Hope Scale (SHS)

    Time frame: 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).

    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).

  2. Change in meaning and purpose in life measured with Meaning in Life Questionnaire (MLQ)

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

    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).

  3. Change in self-esteem measured with Rosenberg Self-Esteem Scale (RSES)

    Time frame: At baseline (T0), post at week 6 (T1) and follow-up at week 18 (T2).

    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).

  4. Change in perceived social support measured with Multidimensional Scale of Perceived Social Support (MSPSS)

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

    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).

Other outcomes

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

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

    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).

Sponsors and collaborators

Lead sponsor

City University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 17, 2020
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.