None listed
Conditions
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.
Interventions
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 usa
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.
Sponsors
Universiti Teknologi MARA
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed