An interventional study of Narrative Intervention in Stigma, Social, sponsored by University of Chicago. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-20.
Sponsored by University of Chicago · Not applicable, Interventional, and Supportive care
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 Medicine's 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.
The proposed study will be a two-arm, non-blinded, 1:1 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 patient's 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.
111 studies on the registry are indexed under Social Stigma; 50 are open to participants now.
This study's enrollment of 215 is above the median of 128 across 93 interventional studies indexed under Social Stigma.
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Exclusion Criteria:
The intervention arm will view a digital story on a tablet created by the research team, then respond to a writing prompt. A baseline abortion stigma and psychological distress survey will be taken at enrollment and then again at follow-up after 2-4 weeks.
Behavioral: Narrative Intervention
The control group will receive care as usual at the abortion clinic. A baseline abortion stigma and psychological distress survey will be taken at enrollment and then again at follow-up after 2-4 weeks.
Participants in the intervention group will first view a digital story on a tablet with headphones that will combine a fictional patient's abortion story with basic medical and social facts regarding abortion. After viewing the narrative, participants 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."
Individual level abortion stigma
Difference in score on the Individual Level Abortion Stigma Scale (ILAS) between baseline and follow-up: The ILAS is a validated 20-item scale that measures individual level stigma with four subscales including: worries about judgment, isolation, self-judgment, and community condemnation. The ILAS has a maximum score of five; in the study that established validity of this scale, the mean score was 1.35 with a standard deviation of 0.63. A higher score indicates greater stigma and a lower score indicates lesser stigma, so a greater decrease in mean scores between baseline and follow-up seen in the intervention group as compared to the control group would indicate an effect of the narrative intervention.
Time frame: 4 weeks
Psychological distress
Difference in score on a modified version of the Profile of Mood States- Short Form (POMS-SF) between baseline and follow-up: Given the length of the POMS-SF, only a few items will be tested. The shortened form is a 37-item questionnaire that asks subjects to rate various adjectives or mood states on a Likert Scale. In this study, the items used will be "sad," "discouraged," "confident," and "satisfied." The scale is scored by adding up the scores associated with negative responses and subtracting the scores associated with positive responses. The maximum score is 4, and the minimum score is zero. A lower score indicates a lower level of psychologic distress. While using only a few items of the POMS-SF has not been specifically validated, we believe that it will provide useful information to evaluate our secondary outcome of psychological distress without placing a significant time burden on participants.
Time frame: 4 weeks
Plan to share: No — The data from this study will not be shared outside of the researchers involved in this protocol.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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