## Protocol Section
### Identification Module
**NCT ID:** NCT06125379

**Brief Title:** Brief Mindfulness-based Intervention for Indonesian Teacher in Rural Area

**Official Title:** Investigating the Effectiveness of Mindfulness-based Intervention on Teachers' Stress and Psychological Well-being in Rural Indonesia

#### Organization Study ID Info
**ID:** 012211183
#### Organization
**Class:** OTHER
**Full Name:** International Islamic University Malaysia
### Status Module
#### Completion Date
**Date:** 2024-06-25

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-28

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-04-25

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-10-15

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2023-11-09
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-26
**Study First Submit QC Date:** 2023-11-04
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Universitas Ahmad Dahlan

#### Lead Sponsor

**Class:** OTHER

**Name:** International Islamic University Malaysia

#### Responsible Party

**Investigator Affiliation:** International Islamic University Malaysia

**Investigator Full Name:** Jamilah Hanum Abdul Khaiyom, PhD

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A randomized controlled trial to assess the effectiveness of the brief mindfulness on teachers' perceived stress and their psychological well-being.

**Detailed Description:** Teacher in early childhood education (ECE) in Indonesia is experiencing high intense stress due to work environment, class management, child behaviour problem, and lack administrative support. Stress has also shown negatively impact their psychological well-being, quality of teaching, and to children's' executive function. Research about stress and the effects on teacher well-being is especially lacking for rural schools. They represent a forgotten minority and thus, teacher from rural area need a prompt and direct support in terms of stress management strategies.

This study employs a randomized wait-list controlled trial design (RCT) with an assessment before and after treatment. 4-weeks brief mindfulness-based protocol will be given to 40 teachers as experimental group. 40 other teachers receive wait-list treatment will assign as control group. Measurement of perceived stress level will be using Indonesian version of Perceived Stress Scale (PSS), psychological wellbeing will be measure using Indonesian Well-being Scale (IWS), and mindfulness traits will be measure using Indonesian version of Five Factor Mindfulness Questionnaire (FFMQ). Data analysis using MANOVA and ANOVA to measure the differences between groups and within groups for all tests and constructs measured.

### Conditions Module

**Conditions:**

- Stress, Psychological

**Keywords:**

- mindfulness

- teacher

- Indonesia

- perceived stress

- well-being

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Group A is an experimental group that will receive mindfulness intervention for 4 consecutive weeks. Group A consists of 2-3 cohorts with 10-15 subjects per cohort.

**Intervention Names:**

- Behavioral: brief mindfulness

**Label:** MindCARE

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Group B is the wait-list control group which did not receive any intervention for 4 weeks.

**Label:** Wait-list control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MindCARE

**Description:** The mindfulness intervention protocol in this study is an adaptation of the Mindfulness Based Stress Reduction (MBSR) protocol with the cultural adaptation suits Indonesia population with addition of Islamic elements (i.e., a series of spiritual approaches) to improve emotional regulation, make sense of their life, be grateful and feel closer to God.

**Name:** brief mindfulness

**Other Names:**

- MindCARE (Mindfulness for Compassion and Relieve Stress)

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The Perceived Stress Scale (PSS-10) is a 10-item questionnaire widely used to assess stress levels in young people and adults aged 12 and above. It evaluates the degree to which an individual has perceived life as unpredictable, uncontrollable and overloading over the previous month. The PSS score is obtained by summing across all items. A total PSS-10 score from 0 to 40 is presented, with higher scores representing higher levels of stress.

**Measure:** Perceived Stress Scale (PSS

**Time Frame:** 4 weeks

#### Secondary Outcomes

**Description:** The IWS is a well-being self-report instrument developed for the Indonesian general population. The scale consisted of 20 favourable items asking the respondent's sense of well-being in five different domains; Basic Needs (BN), Social Relation (SN), Acceptance (SA), Gratitude (GR), and Spirituality (SP). Score is ranging from 20 (minimum) to 100 (maximum), with higher score indicate higer psychological well-being.

**Measure:** Indonesian Well-being Scale (IWS)

**Time Frame:** 4 weeks

**Description:** The FFMQ consists of 39 items asking the individual to rate the extent to which a statement pertaining to mindfulness is applicable, on a scale from 1(never or rarely true) to 5 (very often or always true). Obtained score ranging from 39 (minimum) to 195 (maximum). Nineteen of the 39 items are reverse scored. These 19 items were reverse-scored prior to analysis, such that higher scores indicate higher mindfulness. Seven of the items comprise the non-reactivity facet, and eight items comprise each of the observing, describing, acting with awareness, and non-judging facets. Total scores for each facet are computed by summing the items after reverse scoring.

**Measure:** Five Facet Mindfulness Scale (FFMQ)

**Time Frame:** 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* minimum two years of work experience as early childhood education teacher.
* minimum 25 years of age.
* scoring Moderate (total score 14-26) to High (total score 27-40) perceived stress on PSS-10

Exclusion Criteria:

* have received any formal / manualized mindfulness training prior.
* have ever been diagnosed with chronic stress or other related mental disorders such as anxiety, depression, PTSD.
* people with a history or tendency to commit suicide.
* people with addictive substance dependence who are recovering less than one year.

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 25 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ega@pgpaud.uad.ac.id

**Name:** Ega As Maharani, Master

**Phone:** +6281802720004

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Yogyakarta

**Contacts:**

***Contact 1:***

- **Email:** ega@pgpaud.uad.ac.id

- **Name:** Ega A Maharani, Master

- **Phone:** +6281802720004

- **Role:** CONTACT

**Country:** Indonesia

**Facility:** Ahmad Dahlan University

**Status:** RECRUITING

**Zip:** 55166

#### Overall Officials

**Official 1:**

**Affiliation:** International Islamic University

**Name:** Jamilah HA Khaiyom, Doctoral

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2023-09-10

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 1190186

- Type Abbrev: Prot_SAP

- Upload Date: 2023-10-24T10:55

- Date: 2023-09-10

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 212920

- Type Abbrev: ICF

- Upload Date: 2023-10-24T10:48

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M16105

- Name: Stress, Psychological

- Relevance: HIGH

- As Found: Stress, Psychological

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013315

- Term: Stress, Psychological

### Misc Info Module

- Version Holder: 2024-05-24
