Clinical trial NCT03865199: A Narrative Intervention to Decrease Abortion Stigma
Official title: A Narrative Intervention to Decrease Individual Level Abortion Stigma: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stigma, Social
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Planned Parenthood Federation of America
First posted: 2019-03-06
Enrollment: 215
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women aged 18 or older undergoing medical or surgical abortion at Planned Parenthood of Illinois will be eligible for inclusion in the study. Recruitment will occur two days a week, altering days of the week, and all patients seen on recruitment days not meeting exclusion criteria will be offered the opportunity to enroll after their confirmatory ultrasound. This will be a non-blinded 1:1 randomized controlled trial. Randomization will be done using a computer-generated randomization sequence. A research assistant will place study group assignment in a sealed, opaque, sequentially numbered envelope. This envelope will be opened by the researcher obtaining consent, who will not be involved in clinical care.
Primary purpose: SUPPORTIVE_CARE

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 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Women aged 18 or older undergoing medical or surgical abortion at Planned Parenthood of Illinois (PPIL) will be eligible for inclusion. Inclusion criteria include having an intrauterine pregnancy, having a smart phone to be able to follow-up by text message 2-4 weeks after the clinic appointment, having no contraindications to an outpatient medication or surgical abortion that same day, and not meeting any exclusion criteria.

Exclusion Criteria:

* Exclusion criteria will include non-English speaking, no working telephone, and less than 5th grade education level.

Primary outcomes:
measure: Individual level abortion stigma
timeFrame: 4 weeks
Secondary outcomes:
measure: Psychological distress
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Planned Parenthood
state: Illinois
Study officials:
affiliation: University of Chicago
name: Melissa Gilliam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cockrill K, Upadhyay UD, Turan J, Greene Foster D. The stigma of having an abortion: development of a scale and characteristics of women experiencing abortion stigma. Perspect Sex Reprod Health. 2013 Jun;45(2):79-88. doi: 10.1363/4507913. Epub 2013 May 2.
citation: Shacham S. A shortened version of the Profile of Mood States. J Pers Assess. 1983 Jun;47(3):305-6. doi: 10.1207/s15327752jpa4703_14.