Reproductive Life Planning for Women With Mental Illness

NCT03969589 | Completed Results

• 1 other identifier: PPO 18-089
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Psychotic Disorders; Mood Disorders; Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (3)

• Reproductive Life Goal Behavioral Intentions

  The Reproductive Life Goal Behavioral Intentions scale was used to measure self-reported intentions to engage in behavior to address one's reproductive life goals. A total score was calculated by taking the sum of the responses to the items. The average total score across participants is reported (range = 1 to 5) with higher scores indicating greater intentions to engage in behaviors to address one's reproductive life goals.

  Baseline to 2-Month Post-Intervention (~2 months)

• Reproductive Health Decisional Self-Efficacy

  The Reproductive Health 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.

  Baseline to 2-Month Post-Intervention (~2 months)

• Attitudes Towards Reproductive Life Planning

  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 = 7 to 49) with higher scores indicating more positive/favorable attitudes towards reproductive life planning.

  Baseline to 2-Month Post-Intervention (~2 months)

Study Arms (2)

Reproductive Life Planning-Mental Health Intervention

EXPERIMENTAL

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

Written materials on Reproductive Life Planning

OTHER

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

Interventions

Reproductive Life Planning-Mental Health (RLP-MH) Intervention BEHAVIORAL

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.

Also known as: RLP-MH

Reproductive Life Planning-Mental Health Intervention

Written Materials on Reproductive Life Planning OTHER

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.

Written materials on Reproductive Life Planning

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• currently pregnant
• inability to have children
• e.g. infertility, hysterectomy, tubal ligation

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD

Perry Point, Maryland, 21902, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Mood Disorders; Stress Disorders, Post-Traumatic

Interventions

Methods

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Amy Drapalski
• Organization: VISN 5 MIRECC

amy.drapalski@va.gov

443-421-6273

Study Officials

• Amy L Drapalski, PhD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors are blind to participant condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: July 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: February 28, 2021
• Last Updated: April 22, 2022
• Results First Posted: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)