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出境医 / 临床实验 / Reproductive Life Planning for Women With Mental Illness (RLP-MH)
Reproductive Life Planning for Women With Mental Illness (RLP-MH)
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 | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| 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 : | July 1, 2019 |
| Actual Primary Completion Date : | January 31, 2021 |
| Actual Study Completion Date : | February 28, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
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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.
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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 Name: RLP-MH
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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.
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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.
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Outcome Measures
Primary Outcome Measures :
- Reproductive Life Planning Behavioral Intentions [ Time Frame: Baseline to 2-Month Post-Intervention (~2 months) ]The Reproductive Life Planning Behavioral Intentions scale was used to measure self-reported intentions to engage in behavior to address one's reproductive life goals. A total score is calculated by taking a sum of responses to the items (range = 5 to 15) with higher scores indicating greater intentions to engage in behaviors to address one's reproductive life goals.
- Decisional Self-Efficacy [ Time Frame: Baseline to 2-Month Post-Intervention (~2 months) ]The 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 = 8 to 56) with higher scores indicating more positive/favorable attitudes towards reproductive life planning.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Locations
| United States, Maryland | |
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | |
| Baltimore, Maryland, United States, 21201 | |
| 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 Lynne Drapalski, PhD | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 29, 2019 | ||||||
| First Posted Date ICMJE | May 31, 2019 | ||||||
| Last Update Posted Date | June 7, 2021 | ||||||
| Actual Study Start Date ICMJE | July 1, 2019 | ||||||
| Actual Primary Completion Date | January 31, 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Reproductive Life Planning for Women With Mental Illness | ||||||
| Official Title ICMJE | Reproductive Life Planning for Women Veterans With Mental Illness | ||||||
| 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 | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Masking Description: Assessors are blind to participant condition Primary Purpose: Treatment
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
40 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | February 28, 2021 | ||||||
| Actual Primary Completion Date | January 31, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 40 Years (Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03969589 | ||||||
| Other Study ID Numbers ICMJE | PPO 18-089 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | VA Office of Research and Development | ||||||
| Study Sponsor ICMJE | VA Office of Research and Development | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | VA Office of Research and Development | ||||||
| Verification Date | June 2021 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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