Piloting a Motivational Interviewing Shame-Resilience Training

Shame Clinical Trial

— MIST  

Official title:

Piloting a Motivational Interviewing Shame-Resilience Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05106959
• Other study ID #: 20-059
• Status: Completed
• Phase: N/A
• Start date: June 26, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: October 2021
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the shame resilience theory in a pilot context to assess its feasibility in a potential full scale clinical trial. Shame resilience was developed through qualitative methods but currently has little quantitative backing. Continued research is needed to assess shame-resilience as a potential intervention for shame which little is known to combat prevalent negative health outcomes associated with shame.

Description:

Shame is an emotion that can have significant negative impacts on health outcomes, including engagement in care. Feelings of shame are commonly experienced with stigmatized behaviors, such as substance misuse, and may be particularly strong among pregnant women who misuse substances. Rates of opioid misuse during pregnancy are dramatically rising, particularly in New Mexico, leading to negative health outcomes for mothers and fetuses. Shame has been found to decrease these patients' willingness to attend and engage in care. Although a theoretical model is available to guide interventions to reduce shame, it has not been tested empirically. In the current study, investigators seek to evaluate the preliminary effectiveness and feasibility of a brief Shame Resilience Intervention among women seeking care in UNM's Milagro program, a prenatal medical clinic for opioid using pregnant women. This research has the potential to significantly improve public health by generating a tool to reduce barriers to care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 28, 2021
• Est. primary completion date: December 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Study participants will be Milagro patients

• Engaged in medication assisted treatment

• At least 18 years of age

• Can read and speak English

• Are willing to be contacted for follow-up \

• Are not incarcerated

• Are within the first or second trimester of pregnancy

Exclusion Criteria:

• The study will not enroll non-English speaking Milagro patients

• Patients with obvious cognitive impairments

• Patients with the inability to provide informed consent.

Related Conditions & MeSH terms

• Shame

Intervention

Behavioral:
• Motivational Interviewing Informed Shame Resilience Training
Shame resilience involves four elements. Understating shame, normalizing shame thoughts, reaching out, and speaking shame. Motivational interviewing will be used to elicit and guide participants through these four elements.

Locations

Country	Name	City	State
United States	South-East Heights Clinic	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Willingness to Communicate	This measure looks at participants willingness to communicate about their health on a 5 point Likert Scale; 1-5 with higher scores indicating a greater willingness to communicate. Participants respond to a series of questions on a questionnaire.	1-month
Primary	Adult Trauma Symptom Checklist	This measure looks at current symptoms of past trauma experiences on a 4 point Likert scale; 0-3 with higher scores indicating a greater presence of adult trauma symptoms. Participants respond to a questionnaire.	1-month
Primary	Shame Compass	This measure looks at the intensity and frequency of shame experiences on a 4 point Likert Scale; 0-3 with higher scores indicating a greater intensity and frequency of shame experiences. Participants respond to a questionnaire.	1 month
Primary	WHO Big 5 Subjective Well-Being	This measure looks at participants well-being over the past two weeks on a 5 point Likert Scale; 1-5 with higher scores indicating a higher subjective well-being. Participants respond to a questionnaire.	1-month
Primary	Shame Resilience Amongst Mental Health Trainees	This measure looks at how much a participant is practicing shame resilience on a 4 point Likert Scale; 0-3 with higher scores indicating better shame resilience. Participants respond to a questionnaire.	1-month