Anxiety Clinical Trial
— PM+FMOfficial title:
The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)
Verified date | April 2024 |
Source | Swiss Tropical & Public Health Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
CMHD are particularly prevalent among women, posing a major threat to their own and their children's wellbeing. Despite the high prevalence of CMHD and the existence of effective treatments, interventions supporting women living in low-resourced settings remain limited. This study builds on a parent study (Zamcharts NCT03991182), which identified a high prevalence of women with anxiety and/or depression. We propose to design, test, and validate a community-based intervention nested within the public primary health system in Zambia, to identify and treat women with mild-to-severe CMHDs.
Status | Completed |
Enrollment | 270 |
Est. completion date | December 1, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women participating in ZamCharts parent study - SRQ-20 >7 (clinically significant symptoms of depression or/anxiety), - not planning to move within the next 6 months, - with capacity to consent - not receiving current mental health care. Exclusion Criteria: - Women with active suicidal ideation (determined by Paykel=4 OR 5), - severe substance use (ACOK-SUD >4), - mania or psychotic symptoms |
Country | Name | City | State |
---|---|---|---|
Zambia | Innovatations for Poverty Action | Lusaka |
Lead Sponsor | Collaborator |
---|---|
Swiss Tropical & Public Health Institute | Innovations for Poverty Action |
Zambia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Mental health symptoms. SRQ-20 | 20 items measuring risk of common mental health problem. | Change between Baseline (at enrollment) and 6 months after enrollment | |
Primary | Feasibility of the study | % of 1 or more sessions completed. Qualitative feedback from participants and providers. | Assessed 4 months after enrollment | |
Primary | Acceptability | % of participants completing more than 6 sessions. Qualitative feedback from participants and providers. | Assessed 4 months after enrollment | |
Secondary | Change in Mental health symptoms. PSYCHLOPS | Psychological Outcome Profiles (5 items) | Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment | |
Secondary | Functionality | WHO-DAS2 | Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment | |
Secondary | World Bank's Toolkit and Inventory | Selected measures from the World Bank Toolkit to address mother-child interactions and child early development. | Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment | |
Secondary | Change in Anxiety and Depression symptoms. | HSCL-25. 10 questions anxiety, 15 depression; (a = 0.90). | Used for the pre-post treatment analysis. Change between Baseline (at enrollment) and 4 months after enrollment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04579354 -
Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Completed |
NCT03535805 -
Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances
|
N/A | |
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Active, not recruiting |
NCT05302167 -
Molehill Mountain Feasibility Study.
|
N/A | |
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Completed |
NCT05881681 -
A Mindfulness Approach to UA for Afro-descendants
|
N/A | |
Active, not recruiting |
NCT04961112 -
Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits
|
N/A | |
Terminated |
NCT04612491 -
Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
|
||
Completed |
NCT05980845 -
The Effect Nature Sounds and Music on Hemodialysis Patients
|
N/A | |
Recruiting |
NCT05449002 -
Digital Single Session Intervention for Youth Mental Health
|
N/A | |
Completed |
NCT05585749 -
Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients
|
N/A | |
Terminated |
NCT03272555 -
WILD 5 Wellness: A 30-Day Intervention
|
N/A | |
Recruiting |
NCT05997849 -
Development of a Multiplatform Mental Health Mobile Tool
|
N/A | |
Completed |
NCT06421233 -
The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels
|
N/A |