Clinical trial NCT04631900: Spiritual Intervention for Persons With Depression
Official title: Effect of a Community-oriented Spiritual Intervention Programme in Persons With Depression: a Randomized Wait-list Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Spiritual intervention
Depression
Christian
Connectedness
randomized wait-list
community
Lead sponsor: City University of Hong Kong
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change in depression measured with Patient Health Questionnaire-9 (PHQ-9) score
timeFrame: At baseline (T0), post at week 8 (T1) and follow-up at week 20 (T2).
measure: Change in anxiety measured with General Anxiety Disorder Questionnaire (GAD-7)
timeFrame: At baseline (T0), post at week 8 (T1) and follow-up at week 20 (T2).
Secondary outcomes:
measure: Change in hope measured with State Hope Scale (SHS)
timeFrame: 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).
measure: Change in meaning and purpose in life measured with Meaning in Life Questionnaire (MLQ)
timeFrame: At baseline (T0), post at week 8 (T1) and follow-up at week 20 (T2).
measure: Change in self-esteem measured with Rosenberg Self-Esteem Scale (RSES)
timeFrame: At baseline (T0), post at week 6 (T1) and follow-up at week 18 (T2).
measure: Change in perceived social support measured with Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: At baseline (T0), post at week 8 (T1) and follow-up at week 20 (T2).
Other outcomes:
measure: Change in spiritual experience measured with Daily Spiritual Experience Scale (DSES)
timeFrame: At baseline (T0), post at week 8 (T1) and follow-up at week 20 (T2).
Locations:
city: Hong Kong
country: China
facility: City University of Hong Kong
Study officials:
affiliation: City University of Hong Kong
name: Judy LF LEUNG, PhD(c)
role: PRINCIPAL_INVESTIGATOR
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