Depression Clinical Trial
— MOSAIC PlusOfficial title:
MOSAIC (MOthers' AdvocateS In the Community) for Pregnant Women and Mothers of Children Under 5 With Experience of Intimate Partner Violence: Randomized Trial
The purpose of this R34 exploratory research proposal is to conduct formative work for a larger randomized controlled trial (RCT) evaluating the effectiveness of the "Mother AdvocateS In the Community (MOSAIC) Plus" intervention to reduce depressive and PTSD symptoms and prevent additional IPV among pregnant women and mothers with children under 5 experiencing IPV. The MOSAIC Plus intervention will integrate IPT principles and skills into the MOSAIC intervention in order to expand it to address consequences of IPV, including depression and PTSD symptoms. The proposed study will enroll pregnant women who report experience of IPV in the past 6 months, and who screen positive for elevated depressive and/or PTSD symptoms. The intervention lasts 6 months after enrollment.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 20, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Pregnant and/or are mothers of children under 5 and r - Report IPV experiences in the past 6 months (as assessed by Composite Abuse Scale) - Aged 18 or above, - Have elevated depressive and/or PTSD symptoms as assessed by Patient Health Questionnaire (PHQ-9) with a cutoff point of =9, and/or the Davidson Trauma Scale (DTS) with a cut-off point of =40. Exclusion Criteria: - Cannot provide the name and contact information of at least two locator persons, - Do not have access to any telephone, - Cannot understand English well enough to understand the consent form or assessment instruments when they are read aloud |
Country | Name | City | State |
---|---|---|---|
United States | YWCA Flint | Flint | Michigan |
Lead Sponsor | Collaborator |
---|---|
Michigan State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Provider Competencies | We will assess competency of providers by using Competency Assessment Inventory (CAI) | 6 and 9 months | |
Other | Quality of working relationship-provider perspective | We will assess the quality of working relationship by using the provider perspective section of working alliance inventory. | 3, 6 and 9 months | |
Primary | acceptability | We will evaluate the acceptability of the proposed recruitment methods, research design, intervention training methods, and of delivering the MOSAIC Plus and MOSAIC interventions by using End of Treatment Questionnaire. | 9 months | |
Primary | Satisfaction with care | We will evaluate the feasibility of the proposed recruitment methods, research design, intervention training methods, and of delivering the MOSAIC Plus and MOSAIC interventions by using Client Satisfaction Questionnaire. | 9 months | |
Primary | Quality of Working Relationship | We will evaluate therapeutic alliance by using Working Alliance Inventory-Short Revised (WAI-SR) | 9 months | |
Primary | Reduction in depressive symptoms | We will measure reduction in depressive symptoms as assessed by Patient Health Questionnaire (PHQ-9). | baseline, 3, 6 and 9 months | |
Primary | Reduction in Posttraumatic Stress Disorder Symptoms | We will measure reduction in posttraumatic stress disorder symptoms by using Davidson Trauma Scale. | baseline, 3, 6 and 9 months | |
Secondary | Intimate Partner Violence | We will measure reduction in subsequent intimate partner violence by using Composite Abuse Scale. | baseline, 3, 6 and 9 months | |
Secondary | Effectiveness Obtaining Resources | We will measure effectiveness in obtaining resources by using Effectiveness Obtaining Resources (EOR) scale. | baseline, 3, 6 and 9 months | |
Secondary | Perceived Social Support | We will measure improvements in perceived social support by using The RAND social support scale (Medical Outcome Study-Social Support Survey MOS-SS) | baseline, 3, 6 and 9 months | |
Secondary | Functioning | We will use the WHO Disability Assessment schedule-12 to assess mental health related disability. | baseline, 3, 6 and 9 months | |
Secondary | Self-care and self-worth | We will use the self-care and self-worth scale to assess changes in self-care. | baseline, 3, 6 and 9 months | |
Secondary | General health and wellbeing | We will use the SF-36 to assess changes in general health and wellbeing. | baseline, 3, 6 and 9 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
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)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |