NCT06995807

Brief Summary

This is a research aiming to find the effectiveness of an innovative therapy, EL-SHIN THERAPY, in ameliorating depressive symptoms.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Jun 2025May 2027

First Submitted

Initial submission to the registry

May 7, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

May 7, 2025

Last Update Submit

November 27, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • DASS-21 Scale

    Measuring severity of Depression, Anxiety and Stress Level. Higher score indicating more severity in experiencing these symptoms

    3 to 4 weeks

  • Mental Health Quality of Life (MHQoL)

    Measuring quality of life of individuals. Higher score indicating better quality of life.

    3 to 4 weeks

  • Sleep Quality Scale (SQS)

    Measuring Sleep Quality of Individuals with higher score denoting more acute sleep problem

    3 to 4 weeks

Study Arms (2)

EL-SHIN THERAPY (CONTROL GROUP A)

NO INTERVENTION

Control Group

EL-SHIN THERAPY (GROUP B)

EXPERIMENTAL

Group receiving intervention

Other: EL-SHIN THERAPY

Interventions

Participants will be randomly assigned to Group A and Group B. Group A : Attend a talk on Malaysia Tourism + current coping strategies. Group B : EL-SHIN® Therapy + current coping strategies. Duration of therapies: 2 weeks Assessments using (i) DASS-21 (ii) MHQoL (iii) SLEEP QUALITY SCALE (SQS) at baseline, after 1st week \& 2nd weeks for both groups. Assessment will be done on end of 3rd week to see effect when EL-SHIN Therapy Stopped. Group B participants: Attend a workshop on administration of EL-SHIN® Therapy. Will reinitiate EL-SHIN Therapy on the 4th week and assess on the 8th day to see the effect.

EL-SHIN THERAPY (GROUP B)

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale, Female, Non-Binary, Others (to be specified)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: Above 18 yrs old
  • DASS-21 scores:
  • "Moderately Depressed (Score: 14-20)", "Moderately Anxious (Score: 10-14)" \& "Moderately Stressed (Score: 19-25)"
  • Non-Muslim (Due to legal restriction in Malaysia for this religion)
  • English literate
  • Believers in Creationism

You may not qualify if:

  • Muslim (legal restrictions in Malaysia for this religion).
  • Non-English literate (research will be conducted in English only).
  • Individuals with any other medical conditions or on current medication To reduce potential complications or confounding factors).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monash University Malaysia

Kuala Lumpur, Malaysia

RECRUITING

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Officials

  • AI SHIN LIM, PHD

    Monash University Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AI SHIN LIM, PHD

CONTACT

AI SHIN LIM

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either continue standard treatment with a control activity (Group A) or receive EL-SHIN® Therapy alongside their usual care (Group B).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2025

First Posted

May 30, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

December 1, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations