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NCT03739983 · OUTCOME

Patient Reported Outcomes: Number of Subjects With Improved Depression

Alterations in the Vaginal Microenvironment Using a Non-pharmacological Intervention · Source last updated 2021-10-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
up to 12 weeks

What was measured

Number of subjects with improved depression outcomes over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Emotional Distress - Depression scale measures patient perceived changes in depression and includes 8 questions that they answer about their emotional state in the past 7 days. Descriptive answers are scored from 1 (never) to 5 (always). The total possible range of scores is from 8-40, with higher scores indicating a worse outcome.

Analysis population: only 1 participant completed this survey

Groups in this outcome

VRP Therapy

All subjects on this study will receive the Vaginal Renewal Program (VRP) intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
VRP Therapy1

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
VRP Therapy0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
Number of subjects with improved depression outcomes over baseline. The PROMIS (Patient Reported Outcomes Measurement Information System) Emotional Distress - Depression scale measures patient perceived changes in depression and includes 8 questions that they answer about their emotional state in the past 7 days. Descriptive answers are scored from 1 (never) to 5 (always). The total possible range of scores is from 8-40, with higher scores indicating a worse outcome.
groups
  1. description
    All subjects on this study will receive the Vaginal Renewal Program (VRP) intervention. Enrolled subjects will receive inperson instruction on how to perform the VRP. Subjects will be encouraged to use the device for 3-4 days per week for 5 minutes at a time.
    id
    OG000
    title
    VRP Therapy
param Type
COUNT_OF_PARTICIPANTS
population Description
only 1 participant completed this survey
reporting Status
POSTED
time Frame
up to 12 weeks
title
Patient Reported Outcomes: Number of Subjects With Improved Depression
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice