Reproductive Life Planning for Women With Mental Illness

NCT ID: NCT03969589

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2021-02-28

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.

Detailed Description

Many women Veterans are of reproductive age and, of those, a substantial number experience mental health concerns. Women Veterans with mental illness are at greater risk for unplanned pregnancy and adverse pregnancy outcomes due to factors unique to mental illness and mental health treatment. In addition, mental health and mental health-related concerns associated with pregnancy (e.g. impact of pregnancy on mental health, psychiatric medication use during pregnancy) often affect reproductive life decisions and health outcomes. For these reasons, reproductive life planning (RLP), setting personal goals and plans regarding reproductive intentions, that incorporates considerations and addresses concerns specific to mental health conditions is particularly important for women with mental illness. Despite this need, women Veterans with mental illness rarely receive RLP, and current tools do not adequately consider or address the unique reproductive health considerations women with mental illness often experience.

The investigators adapted existing RLP materials to create an interactive, client-centered RLP intervention specifically designed to address mental health considerations that can influence RLP decisions and outcomes in women Veterans with mental illness. Women Veterans work with a facilitator to explore pregnancy intentions and RLP goals; consider important factors that impact those goals (e.g. medical, mental health or psychosocial concerns); and identify steps to address their RLP goals. As such, the RLP-MH intervention may empower women Veterans with mental illness to take an active role in their reproductive health and engage in behaviors that may improve reproductive outcomes. The goal of the proposed study is to pilot-test the RLP-MH intervention in women Veterans with mental illness to evaluate its feasibility and acceptability, and to explore its potential efficacy compared to provision of written materials on RLP (control condition).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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.

Group Type: OTHER

Written Materials on Reproductive Life Planning

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

RLP-MH

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy L Drapalski, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Baltimore, Maryland, United States

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

Perry Point, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PPO 18-089

Identifier Type: -

Identifier Source: org_study_id