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Reproductive Life Planning for Women With Mental Illness (RLP-MH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03969589
Recruitment Status : Active, not recruiting
First Posted : May 31, 2019
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Women represent the fastest growing population within the VHA. Many are of reproductive age and experience mental health concerns. Women with mental illness are at greater risk for unplanned pregnancy and poor pregnancy outcomes due to factors related to mental health and mental health treatment. Similarly, mental health concerns (e.g., impact of pregnancy on mental illness, psychiatric medications and pregnancy) can affect reproductive life goals and plans. Reproductive life planning (RLP) interventions that include considerations and concerns women Veterans with mental illness face are needed. The investigators adapted existing RLP materials to create an interactive, individualized, client-centered RLP intervention designed to help women Veterans with mental illness develop a mental health-informed reproductive life plan and reproductive life goals (RLP-MH). The current study aims to determine if the RLP-MH intervention is feasible and acceptable to women Veterans and if it increases engagement in behaviors to address RLP goals.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Mood Disorders Stress Disorders, Post-Traumatic Behavioral: Reproductive Life Planning-Mental Health (RLP-MH) Intervention Other: Written Materials on Reproductive Life Planning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Assessors are blind to participant condition
Primary Purpose: Treatment
Official Title: Reproductive Life Planning for Women Veterans With Mental Illness
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Reproductive Life Planning-Mental Health Intervention
Reproductive Life Planning-Mental Health (RLP-MH) intervention is comprised of two parts: 1) an in-person interactive session in which the participant works with an RLP-MH facilitator to explore pregnancy intentions and RLP goals, consider important factors that impact those goals (e.g. mental health and physical health conditions, psychosocial and lifestyle factors, values, preferences), and identify personal action steps to address RLP goals and 2) a 15-20 minute follow-up session in person or by phone one month later to discuss progress in addressing RLP goals.
Behavioral: Reproductive Life Planning-Mental Health (RLP-MH) Intervention
RLP-MH intervention is comprised of two parts: 1) an in-person interactive session in which the participant works with an RLP-MH facilitator to explore pregnancy intentions and RLP goals, consider important factors that impact those goals (e.g. mental health and physical health conditions, psychosocial and lifestyle factors, values, preferences), and identify personal action steps to address RLP goals and 2) a 15-20 minute follow-up session in person or by phone one month later to discuss progress in addressing RLP goals.
Other Name: RLP-MH

Written materials on Reproductive Life Planning
Participants will receive written materials on reproductive life planning, contraception, and VA resources. Participants will be given the materials and study staff will briefly discuss the content with the participant.
Other: Written Materials on Reproductive Life Planning
Participants will receive written materials on reproductive life planning, contraception, and VA resources. Participants will be given the materials and study staff will briefly discuss the content with the participant.




Primary Outcome Measures :
  1. Reproductive Life Planning Behavioral Intentions [ Time Frame: Baseline to 2-Month Post-Intervention (~2 months) ]
    The Reproductive Life Planning Behavioral Intentions scale was used to measure self-reported intentions to engage in behavior to address one's reproductive life goals. A total score is calculated by taking a sum of responses to the items (range = 5 to 15) with higher scores indicating greater intentions to engage in behaviors to address one's reproductive life goals.

  2. Decisional Self-Efficacy [ Time Frame: Baseline to 2-Month Post-Intervention (~2 months) ]
    The Decisional Self-Efficacy scale was used to measures expectations or beliefs about one's ability to engage in behaviors that help in making reproductive life decisions. A total score is calculated by taking the sum of response to the items (range = 0 to 44) with higher scores indicating greater decisional self-efficacy.

  3. Attitudes Towards Reproductive Life Planning [ Time Frame: Baseline to 2-Month Post-Intervention (~2 months) ]
    The Attitudes Towards Reproductive Life Planning developed for this study will be used to measure attitudes towards reproductive life planning and goal setting across several domains key to effective reproductive life planning. A total score is calculated by taking the sum of responses to the items (range = 8 to 56) with higher scores indicating more positive/favorable attitudes towards reproductive life planning.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chart diagnosis of:

    • schizophrenia
    • schizoaffective disorder
    • bipolar disorder
    • major depression
    • PTSD
  • current receiving mental health services at one of the recruitment sites

Exclusion Criteria:

  • currently pregnant
  • inability to have children

    • e.g. infertility, hysterectomy, tubal ligation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969589


Locations
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United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD
Perry Point, Maryland, United States, 21902
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Amy Lynne Drapalski, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03969589    
Other Study ID Numbers: PPO 18-089
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Disease
Mental Disorders
Psychotic Disorders
Mood Disorders
Stress Disorders, Post-Traumatic
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Schizophrenia Spectrum and Other Psychotic Disorders