Clinical trial NCT05106959: Piloting a Motivational Interviewing Shame-Resilience Training
Official title: Piloting a Motivational Interviewing Shame-Resilience Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shame
Keywords: shame resilience
motivational interviewing
shame
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal single group pilot study.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Willingness to Communicate
timeFrame: 1-month
measure: Adult Trauma Symptom Checklist
timeFrame: 1-month
measure: Shame Compass
timeFrame: 1 month
measure: WHO Big 5 Subjective Well-Being
timeFrame: 1-month
measure: Shame Resilience Amongst Mental Health Trainees
timeFrame: 1-month
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: South-East Heights Clinic
state: New Mexico
Study officials:
affiliation: University of New Mexico Department of Family and Community Medicine
name: Jennifer Hettema, PhD
role: PRINCIPAL_INVESTIGATOR
References: