RLP-MH: Reproductive Life Planning for Women With Mental Illness

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT03969589
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Arms: 2
• Actual Duration (Months): 20
• Patients Per Site: 20
• Patients Per Site Per Month: 1

Study Details

Study Description

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	N/A

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).

Study Design

• Study Type: Interventional
• Actual 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: Jul 1, 2019
• Actual Primary Completion Date: Jan 31, 2021
• Actual Study Completion Date: Feb 28, 2021

Arms and Interventions

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 Names: RLP-MH
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.	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.

Outcome Measures

Primary Outcome Measures

1. Reproductive Life Goal Behavioral Intentions [Baseline to 2-Month Post-Intervention (~2 months)]

   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.

2. Reproductive Health Decisional Self-Efficacy [Baseline to 2-Month Post-Intervention (~2 months)]

   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.

3. Attitudes Towards Reproductive Life Planning [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 = 7 to 49) with higher scores indicating more positive/favorable attitudes towards reproductive life planning.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland	United States	21201
2	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

• Principal Investigator: Amy L Drapalski, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 20, 2022
• Informed Consent Form - Nov 24, 2020

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT03969589
• Other Study ID Numbers: PPO 18-089
• First Posted: May 31, 2019
• Last Update Posted: Apr 22, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Disease; Mental Disorders; Psychotic Disorders; Mood Disorders; Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Arm/Group Title	Reproductive Life Planning-Mental Health Intervention	Written Materials on Reproductive Life Planning
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	20	20
COMPLETED	17	17
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Reproductive Life Planning-Mental Health Intervention	Written Materials on Reproductive Life Planning	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.9 (3.9)	34.1 (4.7)	35.0 (4.3)
Sex: Female, Male (Count of Participants)
Female	20 100%	20 100%	40 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	9 45%	10 50%	19 47.5%
White	8 40%	6 30%	14 35%
More than one race	3 15%	4 20%	7 17.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Reproductive Life Goal Behavioral Intentions
Description	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.
Time Frame	Baseline to 2-Month Post-Intervention (~2 months)

Outcome Measure Data

Analysis Population Description

Number analyzed in the rows differ from overall because 3 participants in RLP-MH and 3 in the written materials condition did not complete the 2 month post-treatment assessment

Arm/Group Title	Reproductive Life Planning-Mental Health Intervention	Written Materials on Reproductive Life Planning
Arm/Group Description	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.	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.
Measure Participants	20	20
Baseline	3.6 (1.3)	2.7 (1.5)
2-Month Post Intervention	3.3 (1.4)	3.0 (1.7)

2. Primary Outcome

Title	Reproductive Health Decisional Self-Efficacy
Description	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.
Time Frame	Baseline to 2-Month Post-Intervention (~2 months)

Outcome Measure Data

Analysis Population Description

Number analyzed in the rows differ from overall because 3 participants in RLP-MH and 3 in the written materials condition did not complete the 2-month post-treatment assessment

Arm/Group Title	Reproductive Life Planning-Mental Health Intervention	Written Materials on Reproductive Life Planning
Arm/Group Description	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.	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.
Measure Participants	20	20
Baseline	35.7 (11.9)	33.9 (8.8)
2-Month Post Intervention	40.7 (3.4)	38.7 (6.0)

3. Primary Outcome

Title	Attitudes Towards Reproductive Life Planning
Description	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.
Time Frame	Baseline to 2-Month Post-Intervention (~2 months)

Outcome Measure Data

Analysis Population Description

Number analyzed in the rows differ from overall because 3 participants in RLP-MH and 3 in the written materials condition did not complete the 2-month post-treatment assessment

Arm/Group Title	Reproductive Life Planning-Mental Health Intervention	Written Materials on Reproductive Life Planning
Arm/Group Description	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.	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.
Measure Participants	20	20
Baseline	38.1 (12.5)	42.2 (10.6)
2-Month Post Intervention	38.9 (10.8)	39.4 (11.6)

Adverse Events

Time Frame	Adverse data were collected during their participation in the study (approximately 2 months)
Arm/Group Title	Reproductive Life Planning-Mental Health Intervention		Written Materials on Reproductive Life Planning
Arm/Group Description	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.		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.
All Cause Mortality
	Reproductive Life Planning-Mental Health Intervention		Written Materials on Reproductive Life Planning
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Reproductive Life Planning-Mental Health Intervention		Written Materials on Reproductive Life Planning
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Reproductive Life Planning-Mental Health Intervention		Written Materials on Reproductive Life Planning
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.