Mood Disorders, Psychotic Disorders, Stress Disorders, Post-Traumatic
Conditions
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).
Interventions
BEHAVIORALReproductive 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.
OTHERWritten 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors are blind to participant condition
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Declined Follow-Up | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 2 |
Baseline characteristics
| Characteristic | Reproductive Life Planning-Mental Health Intervention | Total | Written Materials on Reproductive Life Planning |
|---|---|---|---|
| Age, Continuous | 35.9 years STANDARD_DEVIATION 3.9 | 35.0 years STANDARD_DEVIATION 4.3 | 34.1 years STANDARD_DEVIATION 4.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 19 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 14 Participants | 6 Participants |
| Region of Enrollment United States | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Female | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
Time frame: Baseline to 2-Month Post-Intervention (~2 months)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reproductive Life Planning-Mental Health Intervention | Attitudes Towards Reproductive Life Planning | Baseline | 38.1 score on a scale | Standard Deviation 12.5 |
| Reproductive Life Planning-Mental Health Intervention | Attitudes Towards Reproductive Life Planning | 2-Month Post Intervention | 38.9 score on a scale | Standard Deviation 10.8 |
| Written Materials on Reproductive Life Planning | Attitudes Towards Reproductive Life Planning | Baseline | 42.2 score on a scale | Standard Deviation 10.6 |
| Written Materials on Reproductive Life Planning | Attitudes Towards Reproductive Life Planning | 2-Month Post Intervention | 39.4 score on a scale | Standard Deviation 11.6 |
Primary
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.
Time frame: Baseline to 2-Month Post-Intervention (~2 months)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reproductive Life Planning-Mental Health Intervention | Reproductive Health Decisional Self-Efficacy | Baseline | 35.7 score on a scale | Standard Deviation 11.9 |
| Reproductive Life Planning-Mental Health Intervention | Reproductive Health Decisional Self-Efficacy | 2-Month Post Intervention | 40.7 score on a scale | Standard Deviation 3.4 |
| Written Materials on Reproductive Life Planning | Reproductive Health Decisional Self-Efficacy | Baseline | 33.9 score on a scale | Standard Deviation 8.8 |
| Written Materials on Reproductive Life Planning | Reproductive Health Decisional Self-Efficacy | 2-Month Post Intervention | 38.7 score on a scale | Standard Deviation 6 |
Primary
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.
Time frame: Baseline to 2-Month Post-Intervention (~2 months)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reproductive Life Planning-Mental Health Intervention | Reproductive Life Goal Behavioral Intentions | Baseline | 3.6 score on scale | Standard Deviation 1.3 |
| Reproductive Life Planning-Mental Health Intervention | Reproductive Life Goal Behavioral Intentions | 2-Month Post Intervention | 3.3 score on scale | Standard Deviation 1.4 |
| Written Materials on Reproductive Life Planning | Reproductive Life Goal Behavioral Intentions | Baseline | 2.7 score on scale | Standard Deviation 1.5 |
| Written Materials on Reproductive Life Planning | Reproductive Life Goal Behavioral Intentions | 2-Month Post Intervention | 3.0 score on scale | Standard Deviation 1.7 |