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Clinical Trials/NCT04631900
NCT04631900
Completed
Not Applicable

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

City University of Hong Kong1 site in 1 country57 target enrollmentNovember 27, 2021
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
City University of Hong Kong
Enrollment
57
Locations
1
Primary Endpoint
Change in depression measured with Patient Health Questionnaire-9 (PHQ-9) score
Status
Completed
Last Updated
2 years ago

Overview

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.

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

Registry
clinicaltrials.gov
Start Date
November 27, 2021
End Date
March 28, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

LEUNG Lai Fun Judy

Principal Investigator

City University of Hong Kong

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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).

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

  • 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 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 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).)

Study Sites (1)

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