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Completed

NCT Number: NCT05106959

Piloting a Motivational Interviewing Shame-Resilience Training

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.

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Key information

Conditions

Shame

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

South-East Heights Clinic

Albuquerque, New Mexico, 87108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motivational Interviewing Informed Shame Resilience Training

Behavioral

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.

Primary outcomes

  1. Willingness to Communicate

    Time frame: 1-month

    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.

  2. Adult Trauma Symptom Checklist

    Time frame: 1-month

    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.

  3. Shame Compass

    Time frame: 1 month

    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.

  4. WHO Big 5 Subjective Well-Being

    Time frame: 1-month

    This measure looks at participants well-being over the past two weeks on a 6 point Likert Scale; 0-5. Scores range from a minimum of 0 to a maximum of 25, with higher scores indicating a better subjective well-being. Participants respond to a questionnaire.

  5. Shame Resilience Amongst Mental Health Trainees

    Time frame: 1-month

    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.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Acronym: MIST

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Nov 4, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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