Shame
Conditions
Keywords
shame resilience, motivational interviewing, shame
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.
Interventions
BEHAVIORALMotivational 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.
Sponsors
University of New Mexico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Longitudinal single group pilot study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Willingness to Communicate | 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. |
| Adult Trauma Symptom Checklist | 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. |
| Shame Compass | 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. |
| WHO Big 5 Subjective Well-Being | 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. |
| Shame Resilience Amongst Mental Health Trainees | 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. |
Countries
United States
Participant flow
Pre-assignment details
No enrolled participants were excluded from the study
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Pilot Training |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 29.19 Years |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: 1-month
Population: Pregnant women in first or second trimester with opioid use disorder
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pilot Training | Adult Trauma Symptom Checklist | .913 score on a scale | Standard Deviation 0.6318 |
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.
Time frame: 1 month
Population: Pregnant women in first or second trimester with opioid use disorder
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pilot Training | Shame Compass | 1.54 score on a scale | Standard Deviation 0.976 |
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.
Time frame: 1-month
Population: Pregnant women in first or second trimester with opioid use disorder
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pilot Training | Shame Resilience Amongst Mental Health Trainees | 1.83 score on a scale | Standard Deviation 0.4 |
Primary
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.
Time frame: 1-month
Population: Pregnant women in first or second trimester with opioid use disorder
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pilot Training | WHO Big 5 Subjective Well-Being | 15.26 score on a scale | Standard Deviation 5.46 |
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.
Time frame: 1-month
Population: Pregnant women in first or second trimester with opioid use disorder
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pilot Training | Willingness to Communicate | 3.3 score on a scale | Standard Deviation 0.5132 |