Trial Outcomes & Findings for Piloting a Motivational Interviewing Shame-Resilience Training (NCT NCT05106959)
NCT ID: NCT05106959
Last Updated: 2024-09-19
Results Overview
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.
COMPLETED
NA
20 participants
1-month
2024-09-19
Participant Flow
No enrolled participants were excluded from the study
Participant milestones
| Measure |
Pilot Training
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.
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.
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|---|---|
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Overall Study
STARTED
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20
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|
Overall Study
COMPLETED
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19
|
|
Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Pilot Training
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.
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.
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|---|---|
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Piloting a Motivational Interviewing Shame-Resilience Training
Baseline characteristics by cohort
| Measure |
Pilot Training
n=20 Participants
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.
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.19 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
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Region of Enrollment
United States
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20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-monthPopulation: Pregnant women in first or second trimester with opioid use disorder
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.
Outcome measures
| Measure |
Pilot Training
n=19 Participants
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.
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.
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|---|---|
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Willingness to Communicate
|
3.3 score on a scale
Standard Deviation .5132
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PRIMARY outcome
Timeframe: 1-monthPopulation: Pregnant women in first or second trimester with opioid use disorder
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.
Outcome measures
| Measure |
Pilot Training
n=19 Participants
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.
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.
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|---|---|
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Adult Trauma Symptom Checklist
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.913 score on a scale
Standard Deviation .6318
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PRIMARY outcome
Timeframe: 1 monthPopulation: Pregnant women in first or second trimester with opioid use disorder
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.
Outcome measures
| Measure |
Pilot Training
n=19 Participants
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.
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.
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|---|---|
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Shame Compass
|
1.54 score on a scale
Standard Deviation .976
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PRIMARY outcome
Timeframe: 1-monthPopulation: Pregnant women in first or second trimester with opioid use disorder
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.
Outcome measures
| Measure |
Pilot Training
n=19 Participants
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.
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.
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|---|---|
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WHO Big 5 Subjective Well-Being
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15.26 score on a scale
Standard Deviation 5.46
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PRIMARY outcome
Timeframe: 1-monthPopulation: Pregnant women in first or second trimester with opioid use disorder
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.
Outcome measures
| Measure |
Pilot Training
n=19 Participants
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.
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.
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|---|---|
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Shame Resilience Amongst Mental Health Trainees
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1.83 score on a scale
Standard Deviation .40
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Adverse Events
Pilot Training
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cade Arnink
University of New Mexico South West Clinical Trials Network
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place