Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05627206
Other study ID # PM+FMZam
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2022
Est. completion date December 1, 2023

Study information

Verified date April 2024
Source Swiss Tropical & Public Health Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Problem Management + For Moms
Psychosocial intervention conducted by a trained Wellbeing-Community health worker. Adapted from Problem Management +, thinking healthy and Strong Minds-Strong Communities intervention to target women with small children and mental health symptoms living in low-resourced settings. Combines several evidence-based strategies such us psychoeducational, motivational interviewing, cognitive restructuring and relaxation exercises. Organized in 10 weekly sessions (8 individual 2 in group) provided in-person, by phone or virtually.

Locations

Country Name City State
Zambia Innovatations for Poverty Action Lusaka

Sponsors (2)

Lead Sponsor Collaborator
Swiss Tropical & Public Health Institute Innovations for Poverty Action

Country where clinical trial is conducted

Zambia, 

Outcome

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
See also
  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 NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy 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 NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Active, not recruiting NCT05302167 - Molehill Mountain Feasibility Study. N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Active, not recruiting NCT04961112 - Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits N/A
Completed NCT05980845 - The Effect Nature Sounds and Music on Hemodialysis Patients N/A
Terminated NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
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