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NCT03969589: RLP-MH

Reproductive Life Planning for Women With Mental Illness

Completed NA Results posted Last updated 22 April 2022
What this trial tests

NA trial testing Reproductive Life Planning-Mental Health (RLP-MH) Intervention in Psychotic Disorders in 40 participants. Completed in 28 February 2021.

Timeline
1 July 2019
Primary endpoint
31 January 2021
28 February 2021

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment40
Start date1 July 2019
Primary completion31 January 2021
Estimated completion28 February 2021
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 40, female only, with Psychotic Disorders or Mood Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Reproductive Life Goal Behavioral Intentions Primary · 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.

Baseline
GroupValue95% CI
Reproductive Life Planning-Mental Health Intervention3.6± 1.3
Written Materials on Reproductive Life Planning2.7± 1.5
2-Month Post Intervention
GroupValue95% CI
Reproductive Life Planning-Mental Health Intervention3.3± 1.4
Written Materials on Reproductive Life Planning3.0± 1.7
Reproductive Health Decisional Self-Efficacy Primary · 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.

Baseline
GroupValue95% CI
Reproductive Life Planning-Mental Health Intervention35.7± 11.9
Written Materials on Reproductive Life Planning33.9± 8.8
2-Month Post Intervention
GroupValue95% CI
Reproductive Life Planning-Mental Health Intervention40.7± 3.4
Written Materials on Reproductive Life Planning38.7± 6.0
Attitudes Towards Reproductive Life Planning Primary · 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.

Baseline
GroupValue95% CI
Reproductive Life Planning-Mental Health Intervention38.1± 12.5
Written Materials on Reproductive Life Planning42.2± 10.6
2-Month Post Intervention
GroupValue95% CI
Reproductive Life Planning-Mental Health Intervention38.9± 10.8
Written Materials on Reproductive Life Planning39.4± 11.6

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Psychotic Disorders

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03969589.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing