NCT03865199

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

June 16, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

8 months

First QC Date

March 4, 2019

Last Update Submit

April 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (1)

  • Psychological distress

    4 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO 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.

Interventions

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."

Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Planned Parenthood

Chicago, Illinois, 60610, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Melissa Gilliam, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 6, 2019

Study Start

June 16, 2019

Primary Completion

February 5, 2020

Study Completion

February 5, 2020

Last Updated

April 20, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

The data from this study will not be shared outside of the researchers involved in this protocol.

Locations