Viewing Study NCT03865199



Ignite Creation Date: 2024-05-06 @ 12:50 PM
Last Modification Date: 2024-10-26 @ 1:05 PM
Study NCT ID: NCT03865199
Status: COMPLETED
Last Update Posted: 2020-04-20
First Post: 2019-03-04

Brief Title: A Narrative Intervention to Decrease Abortion Stigma
Sponsor: University of Chicago
Organization: University of Chicago

Study Overview

Official Title: A Narrative Intervention to Decrease Individual Level Abortion Stigma A Randomized Controlled Trial
Status: COMPLETED
Status Verified Date: 2020-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Abortion stigma is pervasive in the United States It operates across multiple levels including the individual community and structural While abortion itself does not cause mental health problems due to stigma women who undergo abortion are at risk of suffering negative psychological responses including thought suppression and isolation which can result in psychological distress Few intervention studies have addressed abortion stigma Research in other disciplines in particular mental health has demonstrated the importance of self-validation in improved coping Drawing from psychologists use of writing in cognitive therapy and the discipline of Narrative Medicines emphasis on narrative as a mechanism of healing the proposed study attempts to test a novel intervention to reduce individual level abortion stigma The study will be a randomized controlled trial evaluating a narrative intervention to reduce individual level abortion stigma The principal research question is can a narrative intervention that aims to positively frame the abortion experience decrease individual level abortion stigma An additional research question is will women who take part in a narrative intervention to reduce abortion stigma have improved psychological responses to the abortion Women in the intervention group will view a digital story on a tablet intending to provide education and normalization and then respond to a writing prompt aimed at cognitive restructuring The control group will receive care as usual
Detailed Description: The proposed study will be a two-arm non-blinded 11 randomized controlled trial of a narrative intervention to reduce individual level abortion stigma that will be conducted at Planned Parenthood of Illinois PPIL The narrative intervention combines exposing patients to a digital narrative and then asking them to respond to a writing prompt aiming first to normalize the abortion experience and then to help frame it in positive terms Women randomized to the intervention will view a story created by the research team on a tablet using headphones The story will be read by an actor and digitally recorded for playback by the participant The narrative will combine a fictional patients abortion story with basic medical and social facts regarding abortion After viewing the narrative the participant will be asked to write a narrative either on a tablet provided or on paper with the prompt Patients have different thoughts and feelings about their experiences when they have this procedure Tell a story about yourself or someone else real or imaginary that might help another patient feel supported The goal behind this prompt is to allow the participant to write a narrative that is based in personal experience but that provides the opportunity to mentally join a virtual community through the act of speaking to and helping another theoretical patient Participants randomized to the intervention will complete the intervention during the visit prior to meeting with an educator Participants randomized to the control arm will receive regular care in the abortion clinic

Stigma will be measured at baseline and 2-4 weeks following the intervention with the Individual Level Abortion Stigma Scale ILAS a scale that was developed to measure the impact of abortion stigma interventions Four items from The Profile of Mood States- Short Form POMS-SF will be used to assess psychological distress at the abortion visit and again at follow-up Pre- and post-intervention test scores between groups will be compared in the final analysis

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None