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DepressionNCT04631900

Spiritual Intervention for Persons With Depression

A study testing Christianity approach as framework for spiritual intervention in people with Depression, run by City University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Depression
What is being tested?
Christianity approach as framework for spiritual intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteChina
Study dates
27 Nov 2021to 28 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • City University of Hong Kong

    Hong Kong

Other trials in China

About this study

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

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.

Read the detailed 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
Conditions
Depression
Being tested
Christianity approach as framework for spiritual intervention
Keywords
Spiritual intervention, Depression, Christian, Connectedness, randomized wait-list, community
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Christianity approach as framework for spiritual interventionBehavioural

    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.

Study groups in NCT04631900
Study groupRoleWhat they receive
Spiritual Intervention ProgrammeExperimentalThe 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.
Receives: Behavioral: Christianity approach as framework for spiritual intervention
Wait-list Control groupNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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).

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

Secondary outcomes (4)

  1. 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).

    Measured: 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).

  2. 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).

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

  3. 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).

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

  4. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2020
  2. Study start27 Nov 2021
  3. Primary completion28 Mar 2023
  4. Study completion28 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04631900
Sponsor's protocol ID
judyll2222
Status last verified
Feb 2024
First submitted
10 Nov 2020
Last updated
13 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) from completed clinical trials should be responsibly shared to support efficient clinical research, generate new knowledge and bring benefit to patients. The result can be disseminated via seminars, conference presentations, and various media.

Publications

  • 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.

    PubMed 25095626

  • 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.

  • 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.

    PubMed 11556941

  • 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.

    PubMed 21895357

  • 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.

    PubMed 16287423

  • 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.

    PubMed 22588766

  • 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.

    PubMed 8636885

  • 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.

    PubMed 16717171

  • 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.

    PubMed 29209254

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Christianity approach as framework for spiritual intervention in people with Depression, run by City University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04631900, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.

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Spiritual Intervention for Persons With Depression | AzTrials