Psychotic DisordersRLP-MHNCT03969589
Reproductive Life Planning for Women With Mental Illness
A study testing Reproductive Life Planning-Mental Health (RLP-MH) Intervention and Written Materials on Reproductive Life Planning in people with Psychotic Disorders and Mood Disorders, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Psychotic Disorders, Mood Disorders, Stress Disorders, Post-Traumatic
- What is being tested?
- Reproductive Life Planning-Mental Health (RLP-MH) Intervention and Written Materials on Reproductive Life Planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2019to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- chart diagnosis of:
- schizophrenia
- schizoaffective disorder
- bipolar disorder
- major depression
- PTSD
- current receiving mental health services at one of the recruitment sites
Who cannot join
- currently pregnant
- inability to have children
- e.g. infertility, hysterectomy, tubal ligation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD
Perry Point, Maryland, 21902
About this study
Official title: Reproductive Life Planning for Women Veterans With Mental Illness
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.
Read the 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).
- Being tested
- Reproductive Life Planning-Mental Health (RLP-MH) Intervention, Written Materials on Reproductive Life Planning
- Medical subject headings
- Psychotic Disorders, Mood Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reproductive Life Planning-Mental Health (RLP-MH) InterventionBehavioural
Also called RLP-MH
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 PlanningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Written Materials on Reproductive Life Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to 2-Month Post-Intervention (~2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start1 Jul 2019
- Primary completion31 Jan 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Amy L Drapalski, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969589
- Sponsor's protocol ID
- PPO 18-089
- Acronym
- RLP-MH
- Status last verified
- Apr 2022
- First submitted
- 29 May 2019
- Last updated
- 22 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductive Life Planning for Women Veterans With Mental Illness
- ClinicalTrials.gov ID
- NCT03969589
- Acronym / sponsor ID
- RLP-MH / PPO 18-089
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Posted 22 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reproductive Life Planning-Mental Health Intervention | Experimental | Behavioral: Reproductive Life Planning-Mental Health (RLP-MH) InterventionReproductive 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. |
| Written materials on Reproductive Life Planning | Other | Other: Written Materials on Reproductive Life PlanningParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- chart diagnosis of:
- current receiving mental health services at one of the recruitment sites
Key exclusion criteria (3 listed)
- currently pregnant
- inability to have children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reproductive Life Planning-Mental Health (RLP-MH) InterventionAlso: RLP-MHRLP-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. | Behavioural | Reproductive Life Planning-Mental Health Intervention |
| Written Materials on Reproductive Life PlanningParticipants 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 |
Primary outcome
Reproductive Life Goal Behavioral Intentions
Time frame: 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.
Reproductive Health Decisional Self-Efficacy
Time frame: 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.
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 = 7 to 49) with higher scores indicating more positive/favorable attitudes towards reproductive life planning.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy L Drapalski, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reproductive Life Planning-Mental Health (RLP-MH) Intervention and Written Materials on Reproductive Life Planning in people with Psychotic Disorders and Mood Disorders, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproductive Life Goal Behavioral Intentions (time frame: Baseline to 2-Month Post-Intervention (~2 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.