Piloting a Motivational Interviewing Shame-Resilience Training

NCT05106959 | Completed Results

• 1 other identifier: 20-059
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Shame

Keywords

shame resilience; motivational interviewing; shame

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• WHO Big 5 Subjective Well-Being

  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.

  1-month

• 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

Study Arms (1)

Pilot Training

EXPERIMENTAL

In this arm participants will complete a variety of baseline assessments then participate in 15-20 minute conversation based on motivational interviewing principles in which they are trained in shame resilience. Follow-ups will be conducted a month later. Assessments will be repeated and then participants will engage in a qualitative interview regarding the training.

Behavioral: Motivational Interviewing Informed Shame Resilience Training

Interventions

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.

Pilot Training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The study will not enroll non-English speaking Milagro patients
• Patients with obvious cognitive impairments
• Patients with the inability to provide informed consent.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

South-East Heights Clinic

Albuquerque, New Mexico, 87108, United States

Location

Limitations and Caveats

Utilizing more than one study-interventionist could potentially have indicated differential outcomes in the administration of the intervention. Finally the study was designed pre-covid and had to be adapted for covid limitations.

Results Point of Contact

• Title: Cade Arnink
• Organization: University of New Mexico South West Clinical Trials Network

clarnink@salud.unm.edu

505-918-0341

Study Officials

• Jennifer Hettema, PhD

  University of New Mexico Department of Family and Community Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Longitudinal single group pilot study.

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: November 4, 2021
• Study Start: June 26, 2020
• Primary Completion: December 16, 2020
• Study Completion: February 28, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)