STEP for Psychological Trauma

1
Effectiveness
1
Safety
Centre intégré de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec, Trois-Rivières, Canada
Psychological Trauma+5 More
STEP - Behavioral
Eligibility
18+
Female
Eligible conditions
Psychological Trauma

Study Summary

Supporting the Transition to and Engagement in Parenthood

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Eligible Conditions

  • Psychological Trauma
  • Wounds
  • Mental Health Issue
  • Distress; Maternal
  • Prenatal Stress
  • Trauma, Psychological
  • Wounds and Injuries

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether STEP will improve 6 primary outcomes, 17 secondary outcomes, and 4 other outcomes in patients with Psychological Trauma. Measurement will happen over the course of Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of self-compassion..

Administered at one time-point, around 12-months postpartum. The measure will assess current maternal behaviors..
Maternal behaviors
Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.
Infant general development
Infant socio-emotional development
Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.
Change in trauma-specific reflective functioning
Parental reflective functioning
Administered at one time-point, at 6-moths postpartum.The measure will assess current infant temperament
Infant temperament
Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of maternal bonding.
Maternal bonding
Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of parental stress.
Parental stress
Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of perceived maternal competence..
Maternal competence
Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of post-traumatic growth.
Post-traumatic growth
Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of reflective functions.
Prenatal reflective functioning
Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of self-compassion.
Self-compassion
Month 9
Perception of change in domains of functioning during pregnancy
Administered at one time-point, at the second trimester of pregnancy. The measure will assess current level of personality dysfunctions.
Personality dysfunctions
Month 7
Depression
Month 7
Change in perception of parental competence
Month 7
Change in antenatal attachment
Change in emotion regulation strategies
Month 13
Change in Inflammation
Change in affective states from baseline (2nd trimester of pregnancy) to the end of the third trimester of pregnancy (around 36 weeks) and from baseline to 6-months postpartum
Change in anger from baseline (2nd trimester of pregnancy) to the end of the third trimester of pregnancy (around 36 weeks) and from baseline to 6-months postpartum
Change in cortisol
Change in intimate partner violence
Change in post-traumatic stress symptoms from baseline (2nd trimester of pregnancy) to the end of the third trimester of pregnancy (around 36 weeks) and from baseline to 6-months postpartum
Change in psychological distress from baseline (2nd trimester of pregnancy) to the end of the third trimester of pregnancy (around 36 weeks) and from baseline to 6-months postpartum
Month 7
Connection to care
Satisfaction assessed after each session of the program and after its ending. Satisfaction is thus assessed between the second trimester of pregnancy and 36-weeks of pregnancy, for a total time frame up to 7-months.
Level of satisfaction concerning the intervention

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
STEP

This trial requires 110 total participants across 2 different treatment groups

This trial involves 2 different treatments. STEP is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

STEP
Behavioral
Participants will participate, online or in-person, to the 8-9 sessions of the program addressing the psychological experience of pregnancy and supporting reflective capacities in relation to trauma and motherhood.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
STEP
2014
Completed Phase 3
~80

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. the assessment time frame thus covers a period of 13 months.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. the assessment time frame thus covers a period of 13 months. for reporting.

Who is running the study

Principal Investigator
N. B.
Prof. Nicolas Berthelot, Professor
Université du Québec à Trois-Rivières

Closest Location

Centre intégré de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec - Trois-Rivières, Canada

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Pregnant women ages 18+ years
Interested in reflecting about their experience of pregnancy and willing to attend weekly sessions in group setting.
Must speak French as their first language

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for psychological trauma?

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Physical health problems are typically not addressed through treatment (other than for pain). However, some studies indicate that massage may be beneficial, and research is ongoing concerning the effects of aerobic exercise and psychotherapy for other health issues such as anxiety. Several studies suggest that stress-reducing, relaxation techniques, or even meditation may have effects on other health conditions such as osteoporosis and hypertension in individuals with poor mental health; however, little research exists to validate such relationships. Research indicates that cognitive-behavioural therapy and brief psychodynamic psychotherapy are efficacious in treating PTSD; however, this is only a matter of conjecture given limited research.

Unverified Answer

What causes psychological trauma?

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The experience of childhood trauma/abuse contributes to the early development of PD. Findings from a recent study can inform the identification of individuals at risk for PD by providing clinical rationale for specific screenings and treatment of these individuals.

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What are the signs of psychological trauma?

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Psychological trauma refers to a broad assortment of symptoms and signs of both physical and mental dysfunction. Symptoms of psychological trauma may include a tendency to worry, trouble feeling happy, feeling anxious or depressed and numbness. Psychological trauma is not necessarily a mental illness in itself, but it is certainly associated with symptoms and signs of physical disease.\n

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How many people get psychological trauma a year in the United States?

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At least 80% of all deaths will result from psychological traumas. This highlights the need to make psychology a core academic discipline within medical curricula.

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Can psychological trauma be cured?

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We suggest that trauma management in general should be assessed using the following three-stage criterion to allow for a proper definition of 'cure': (a) 1) the person is not able to tolerate an adverse emotional experience; (b) the adverse emotional experience is only a fraction of what the person would have experienced prior to the trauma event and may include a period of time that is not relatable to the person; (c) the person is still suffering from the trauma experience.

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What is psychological trauma?

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Psychological trauma is a multifaceted concept reflecting the impact of early adverse experience on the whole experience of an adult; and a process by which an individual may be traumatized in different ways. Psychological trauma, thus, can be defined as any traumatic experience lasting for at least six months with a degree of psychological distress. In adult psychiatry, it refers to symptoms of psychological problems that have developed as a result of physical trauma as in acute, chronic and chronic PTSD.

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What is step?

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In the present study, the presence or absence of step in children and adolescent mothers was correlated with the amount and severity of PTSD symptoms experienced by their children. This finding is the first indication to suggest the importance of the mother's step in developing PTSD-related symptoms in her child. Further study is needed to better understand the process of step and determine whether it is causative (through which variables) or consequential. Copyright © 1991 Wiley Periodicals, Inc.

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What is the average age someone gets psychological trauma?

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A significant minority of patients get psychological trauma well before the age of 20. A significant minority of patients get psychological trauma long after the age of 60. This suggests a long-term cumulative ntrauma effect. Patients should be informed of this in the context of counseling and treatment.

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Have there been any new discoveries for treating psychological trauma?

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Although there is some advancement in the treatment of PTSD and TBI, many doctors and nurses are still hesitant to diagnose or treat these mental illnesses, while some other hospitals have abandoned their PTSD and TBI programs. In our era, if there are new treatments we should see them through, so we can help patients and their families better.

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What are the latest developments in step for therapeutic use?

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It is obvious that the field is continually changing with a plethora of new advances in both clinical and basic science. What is also undeniable are the significant advances in our understanding of the etiology and pathogenesis of PTSD, thus helping to guide the development of more refined, evidence-based therapies and treatments. However, many issues remain unresolved and the way to further enhance our understanding is not yet clear. In this regard, clinical trials in this field will continue to play an essential role to help us further understand the mechanisms involved and develop better therapies.

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Has step proven to be more effective than a placebo?

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We were surprised that an unproven intervention, a multi-step relaxation protocol, can be effective in controlling acute stress symptoms. The same treatment also seemed to be effective as a preventive strategy among the subjects who suffered post-traumatic stress disorder following a trauma. The use of relaxation could offer a new way of mitigating the detrimental effects of long-term trauma, such as PTSD.

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Does step improve quality of life for those with psychological trauma?

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step treatment is effective and is able to significantly improve quality of life outcomes for PTSD. This treatment may be most effective in women and in those who report a positive response toward treatment.

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