ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626001155381

Ethics application status

Approved

Date submitted

17/04/2026

Date registered

17/09/2026

Date last updated

17/09/2026

Date data sharing statement initially provided

17/09/2026

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effect of Flexminda Mobile Mental Health App on Psychological Distress among Psychiatric Patients: A Pilot Randomized Controlled Trial

Scientific title

A Pilot Study on the Attitude, Usability, and Efficacy of a Mobile Mental Health Application (Flexminda) on Psychological Distress Symptoms among Patients with Major Depressive Disorder or Generalized Anxiety Disorder in Hospital Al-Sultan Abdullah, Selangor: A Randomized-Control Trial

Additional trial identifiers [1]

Nil

Universal Trial Number (UTN)

Trial acronym

FLEXMINDA

Related trial records

Health condition

Health condition(s) studied:

Major Depressive Disorder

Generalized Anxiety Disorder

Psychological Distress

Mental Health

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

Participants in the Flexminda group (Flex) receive treatment as usual (TAU) combined with guided use of the Flexminda bilingual (Malay/English) mobile mental health application for 12 weeks.

MATERIALS: The Flexminda app (available on Google Play Store and Apple App Store) contains evidence-based self-help features including self-administered mental health screening tools (PHQ-9, DASS-21), mood diary, gratitude journaling, mindfulness activities, self-harm monitoring, internet/social media usage monitoring, and a directory of mental health service providers.

PROCEDURES: At enrolment (T0), the treating psychiatrist guides each participant through app features using a standardised manual tailored to diagnosis. MDD patients: mood diary, self-harm monitoring, mindfulness. GAD patients: mood diary, mindfulness, gratitude journaling. All participants may freely use any other app features.

DELIVERY: Individual, face-to-face guidance at Psychiatric Clinic, Hospital Al-Sultan Abdullah UiTM, Puncak Alam. WhatsApp text reminders fortnightly. Booster session at Week 6 (T1).

DURATION: 12 weeks (T0 to T2)

The intervention has two components: (1) individual, face-to-face sessions
in which the treating psychiatrist guides the participant through the
Flexminda app using a standardised manual, and (2) independent use of the
app by the participant between and after these sessions.

There are two guided sessions over the 12-week period: an initial session
at enrolment (T0) and a booster session at Week 6 (T1), each delivered
individually and face-to-face at the Psychiatric Clinic, Hospital
Al-Sultan Abdullah UiTM, Puncak Alam, each lasting approximately
15 minutes.

At T0, the standardised manual directs MDD participants toward the mood
diary, self-harm monitoring, and mindfulness features, and GAD participants
toward the mood diary, mindfulness, and gratitude journaling features.
Participants may freely use any other app features at their discretion.
The T1 booster session uses the same standardised manual to review and
reinforce engagement with the app.

Between sessions, app use is at the participant's discretion. Fortnightly
WhatsApp text reminders are sent to support continued engagement throughout
the 12-week period.

Adherence is assessed through participant self-report of app use frequency,
collected at the Week 6 (T1) and Week 12 (T2) clinic visits.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Description of the comparator or control

Participants in the Treatment as Usual (TAU) group receive standard psychiatric care as clinically indicated by their treating psychiatrist. This includes antidepressant medication and/or psychological intervention. No mobile application is provided during the 12-week study period. Following study completion, the Flexminda app will be offered to Treatment as Usual (TAU) participants.

Control group

Active

Outcomes

Primary outcome [1]

Change in depression symptom severity score from baseline

Timepoint [1]

Baseline (T0), Week 6 (T1), and Week 12 (T2, primary timepoint) after commencement of intervention

Secondary outcome [1]

Change in anxiety symptom severity score from baseline

Timepoint [1]

Baseline (T0), Week 6 (T1), and Week 12 (T2) after commencement of intervention

Secondary outcome [2]

Participants' awareness and attitude toward mobile mental health app use

Timepoint [2]

Baseline (T0), Week 6 (T1), and Week 12 (T2) after commencement of intervention

Secondary outcome [3]

Usability of the Flexminda app

Timepoint [3]

Week 12 (T2) after commencement of intervention. Applied to Flex group only.

Eligibility

Key inclusion criteria

1. Aged 18 years and above
2. Diagnosed with major depressive disorder (MDD) or generalized anxiety disorder (GAD) for at least 6 weeks
3. Owns a smartphone (Android or iOS) compatible with the Flexminda application
4. Able to understand Malay and/or English 5. Willing to provide written informed consent

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

1. Diagnosed with major depressive disorder with psychotic features
2. Diagnosed with generalized anxiety disorder with comorbid major depressive disorder
3. Active suicidal ideation — defined as a score of 1 or more on Question 9 of the PHQ-9
4. Refusal to participate in the study

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Concealed. Computer-generated block randomisation list held by the research team separately from clinicians enrolling participants. Allocation revealed only after eligibility confirmation and written consent obtained.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computerised sequence generation using block randomisation stratified by gender (block size 34 per gender stratum). Each arm contains 17 MDD and 17 GAD patients using an alternating method. Generated using computer software.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size calculated using OpenEpi V3.01 based on Tighe et al. (2017), comparing PHQ-9 at 6 weeks: control 12.8 ± 5.5, intervention 8.9 ± 5.4 (difference 3.9 units). After 10% attrition adjustment: 34 per arm (N=68 minimum). Actual enrolment: 74 (38 MDD, 36 GAD). Analysis: SPSS V28.0. Continuous data as mean ± SD; categorical as frequencies/percentages. Normality by Kolmogorov-Smirnov test. Between- and within-group differences by repeated-measures ANOVA (RM-ANOVA). Intention-to-treat analysis. Significance: p < 0.05.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

10/02/2025

Date of last participant enrolment

Anticipated

Actual

2/04/2026

Date of last data collection

Anticipated

Actual

1/07/2026

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Selangor

Funding & Sponsors

Funding source category [1]

University

Name [1]

Universiti Teknologi MARA

Address [1]

Country [1]

Malaysia

Primary sponsor type

University

Name

Universiti Teknologi MARA

Address

Country

Malaysia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Commercial sector/Industry

Name [1]

MyndaTech Solutions Plt

Address [1]

Country [1]

Malaysia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research Ethics Committee, Universiti Teknologi MARA

Ethics committee address [1]

Pejabat Timbalan Naib Canselor (Penyelidikan dan Inovasi), UiTM, Aras 3 Bangunan Wawasan, 40450 Shah Alam, Selangor

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

10/11/2024

Approval date [1]

08/01/2025

Ethics approval number [1]

REC/01/2025 (ST/CT/1)

Ethics committee name [2]

Hospital Al-Sultan Abdullah UiTM Research Committee

Ethics committee address [2]

Department of Research, Innovation & Industrial Linkages (PJI), Hospital Al-Sultan Abdullah UiTM, Level 5, Kampus Puncak Alam, 42300 Puncak Alam, Selangor

Ethics committee country [2]

Malaysia

Date submitted for ethics approval [2]

06/12/2024

Approval date [2]

07/02/2025

Ethics approval number [2]

500-HUiTM (PJI.18/4/03)

Summary

Brief summary

Mental health problems are increasing in Malaysia, with limited access to mental health professionals. Mobile mental health apps offer an accessible and affordable complement to traditional treatment. This pilot randomized controlled trial evaluates whether using the Flexminda app — a bilingual (Malay and English) mobile mental health application — alongside standard psychiatric treatment helps reduce symptoms of depression and anxiety in patients attending a psychiatric clinic. Participants are randomly assigned to either standard treatment alone, or standard treatment plus 12 weeks of guided Flexminda app use. Symptom severity, awareness and attitudes toward mental health apps, and app usability are assessed at baseline, Week 6, and Week 12.

Trial website

Trial related presentations / publications

Public notes

This trial was retrospectively registered. Recruitment commenced in February 2025 prior to registration due to lack of awareness of prospective registration requirements. Both UiTM Research Ethics Committee (approved 08/01/2025) and Hospital Al-Sultan Abdullah UiTM ethics committee (approved 07/02/2025) approvals were obtained before commencement of data collection.

Contacts

Principal investigator

Name

A/Prof Salina Mohamed

Address

Department of Psychiatry, Faculty of Medicine, UiTM Sungai Buloh Campus Address: Jalan Hospital, 47000 Sungai Buloh, Selangor, Malaysia

Country

Malaysia

Phone

+60122016985

Fax

[email protected]

Contact person for public queries

Name

Salina Mohamed

Address

Department of Psychiatry, Faculty of Medicine, UiTM Sungai Buloh Campus Address: Jalan Hospital, 47000 Sungai Buloh, Selangor, Malaysia

Country

Malaysia

Phone

+60122016985

Fax

[email protected]

Contact person for scientific queries

Name

Salina Mohamed

Address

Department of Psychiatry, Faculty of Medicine, UiTM Sungai Buloh Campus Address: Jalan Hospital, 47000 Sungai Buloh, Selangor, Malaysia

Country

Malaysia

Phone

+60122016985

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: Individual participant data will not be shared publicly to protect participant confidentiality. Aggregated results will be reported in peer-reviewed publications.

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Ethical approval					Approval letter from REC for Flexminda.pdf
Ethical approval					Approval letter from HASA for Flexminda.pdf
Informed consent form					Flexminda PIS & Consent.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically