Stigma, SocialNCT03865199
A Narrative Intervention to Decrease Abortion Stigma
A study testing Narrative Intervention in people with Stigma, Social, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stigma, Social
- What is being tested?
- Narrative Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2019to 5 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria will include non-English speaking, no working telephone, and less than 5th grade education level.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Narrative Intervention to Decrease Individual Level Abortion Stigma: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Stigma, Social
- Being tested
- Narrative Intervention
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative InterventionBehavioural
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."
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start16 Jun 2019
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stigma, SocialStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Planned Parenthood Federation of America
- Responsible party
- Sponsor
- Investigators
- Melissa Gilliam, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865199
- Sponsor's protocol ID
- IRB18-1683
- Status last verified
- Apr 2020
- First submitted
- 4 Mar 2019
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data from this study will not be shared outside of the researchers involved in this protocol.
Publications
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.
PubMed 23750622Shacham S. A shortened version of the Profile of Mood States. J Pers Assess. 1983 Jun;47(3):305-6. doi: 10.1207/s15327752jpa4703_14.
PubMed 6886962
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Narrative Intervention to Decrease Individual Level Abortion Stigma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03865199
- Acronym / sponsor ID
- IRB18-1683
- Conditions
- Stigma, Social
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Planned Parenthood Federation of America
- Study start
- 16 Jun 2019 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Narrative InterventionThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion criteria will include non-English speaking, no working telephone, and less than 5th grade education level.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative InterventionParticipants 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." | Behavioural | Intervention Group |
Primary outcome
Individual level abortion stigma
Time frame: 4 weeks
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.
1 secondary outcome
Psychological distress
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Results publication: PubMed 23750622Cockrill 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.
- Results publication: PubMed 6886962Shacham S. A shortened version of the Profile of Mood States. J Pers Assess. 1983 Jun;47(3):305-6. doi: 10.1207/s15327752jpa4703_14.
- Individual participant dataSharing planned: No. The data from this study will not be shared outside of the researchers involved in this protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Gilliam, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Intervention in people with Stigma, Social, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual level abortion stigma (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03865199, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.