TTOP_PSY: Therapeutic Termination of Pregnancy and Psychiatric Implications

Sponsor

University of Milano Bicocca (Other)

Overall Status

Completed

CT.gov ID

NCT04080141

Collaborator

(none)

Enrollment

90.7

Actual Duration (Months)

Study Details

Study Description

Brief Summary

25 parental couples, with a prenatal diagnosis of fetal abnormality, had psychiatric evaluation for eligibility before TToP and after one year from the procedure. Women and unborn's fathers were also subjected to different psychometric questionnaires (HAM-D, HAM-A, BDI-II, PCL-5, IPDS, CTQ, CD-RISC-10).

Condition or Disease	Intervention/Treatment	Phase
Therapeutic Abortion With Complications Personality Disorders Trauma, Psychological Reproductive Behavior Post Traumatic Stress Disorder Depression, Reactive	Diagnostic Test: Multiple psychometric questionnaire Procedure: Clinical psychiatric examination

Detailed Description

The therapeutic interruption of pregnancy (TTOP) may have psychiatric outcomes like depression, anxiety and post-traumatic stress disorder (PTSD). Personality issues, childhood traumas and paternal consequences are too little investigated in current Literature.

The investigator's aim is exploring the contribution of maternal personality disorders and maternal history of childhood traumas to psychiatric outcomes after a TToP, paternal psychiatric outcomes and their role on their partner's psychopathological and psychiatric outcomes.

25 couples, with a prenatal diagnosis of fetal abnormality, had psychiatric evaluation for eligibility before TToP and after one year from the procedure. Women and unborn's fathers were also subjected to different psychometric questionnaires (HAM-D, HAM-A, BDI-II, PCL-5, IPDS, CTQ, CD-RISC-10).

At the time of first contact (T0) only women were subjected to a psychiatric clinical examination in order to evaluate their legal eligibility to TToP, according to Italian Law n. 194/78. At T0 women were also subjected to Hamilton's rating scale for depression (HRSD or HAM-D), Hamilton's rating scale for anxiety (HRSA or HAM-A), Beck Depression Inventory (BDI-II). At the follow up after 1 year from the first examination (T1) the parental couples were subjected to a questionnaire with multiple psychometric tests for mother and her partner. The female version included Post-traumatic stress disorder checklist (PCL-5), Iowa Personality Disorder Screen (IPDS), Beck Depression Inventory (BDI-II), Connor-Davidson Resilience Scale 10 (CD-RISC 10) and Short-Form Questionnaire on childhood trauma (CTQ-SF). The male version included Post-traumatic stress disorder checklist (PCL-5), Iowa Personality Disorder Screen (IPDS), Connor-Davidson Resilience Scale 10 (CD-RISC 10) and Short-Form Questionnaire on childhood trauma (CTQ-SF).

Study Design

Study Type:

Observational

Actual Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Therapeutic Termination of Pregnancy: Maternal and Paternal Mental Health Before and in the Long-term

Actual Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Dec 31, 2016

Actual Study Completion Date :

Jul 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
PD+ Subjects with personality disorder	Diagnostic Test: Multiple psychometric questionnaire At the time of first contact (T0) only women were subjected to Hamilton's rating scale for depression (HRSD or HAM-D), Hamilton's rating scale for anxiety (HRSA or HAM-A), Beck Depression Inventory (BDI-II). At the follow up after 1 year from the first examination (T1) they were subjected to a questionnaire with multiple psychometric tests for mother and her partner. The female version included Post-traumatic stress disorder checklist (PCL-5), Iowa Personality Disorder Screen (IPDS), Beck Depression Inventory (BDI-II), Connor-Davidson Resilience Scale 10 (CD-RISC 10) and Short-Form Questionnaire on childhood trauma (CTQ-SF). The male version included Post-traumatic stress disorder checklist (PCL-5), Iowa Personality Disorder Screen (IPDS), Connor-Davidson Resilience Scale 10 (CD-RISC 10) and Short-Form Questionnaire on childhood trauma (CTQ-SF). Procedure: Clinical psychiatric examination At the time of first contact (T0) only women were subjected to psychiatric clinical examination
PD- Subjects without personality disorder	Diagnostic Test: Multiple psychometric questionnaire At the time of first contact (T0) only women were subjected to Hamilton's rating scale for depression (HRSD or HAM-D), Hamilton's rating scale for anxiety (HRSA or HAM-A), Beck Depression Inventory (BDI-II). At the follow up after 1 year from the first examination (T1) they were subjected to a questionnaire with multiple psychometric tests for mother and her partner. The female version included Post-traumatic stress disorder checklist (PCL-5), Iowa Personality Disorder Screen (IPDS), Beck Depression Inventory (BDI-II), Connor-Davidson Resilience Scale 10 (CD-RISC 10) and Short-Form Questionnaire on childhood trauma (CTQ-SF). The male version included Post-traumatic stress disorder checklist (PCL-5), Iowa Personality Disorder Screen (IPDS), Connor-Davidson Resilience Scale 10 (CD-RISC 10) and Short-Form Questionnaire on childhood trauma (CTQ-SF). Procedure: Clinical psychiatric examination At the time of first contact (T0) only women were subjected to psychiatric clinical examination

Arm

Intervention/Treatment

PD+

Subjects with personality disorder

Diagnostic Test: Multiple psychometric questionnaire

At the time of first contact (T0) only women were subjected to Hamilton's rating scale for depression (HRSD or HAM-D), Hamilton's rating scale for anxiety (HRSA or HAM-A), Beck Depression Inventory (BDI-II). At the follow up after 1 year from the first examination (T1) they were subjected to a questionnaire with multiple psychometric tests for mother and her partner. The female version included Post-traumatic stress disorder checklist (PCL-5), Iowa Personality Disorder Screen (IPDS), Beck Depression Inventory (BDI-II), Connor-Davidson Resilience Scale 10 (CD-RISC 10) and Short-Form Questionnaire on childhood trauma (CTQ-SF). The male version included Post-traumatic stress disorder checklist (PCL-5), Iowa Personality Disorder Screen (IPDS), Connor-Davidson Resilience Scale 10 (CD-RISC 10) and Short-Form Questionnaire on childhood trauma (CTQ-SF).

Procedure: Clinical psychiatric examination

At the time of first contact (T0) only women were subjected to psychiatric clinical examination

PD-

Subjects without personality disorder

Diagnostic Test: Multiple psychometric questionnaire

Procedure: Clinical psychiatric examination

At the time of first contact (T0) only women were subjected to psychiatric clinical examination

Outcome Measures

Primary Outcome Measures

Depressive symptoms in women [1 year]
Change from Baseline in number of women with depressive symptoms at 1 year after TToP assessed with the Beck Depression Inventory, which measure the severity of depressive symptoms. The long form of the Beck Depression Inventory is composed of 21 questions or items, each with four possible responses. Each response is assigned a score ranging from zero to three, indicating the severity of the symptom. The sum of all item scores indicates the severity of depression. Scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression. So, a higher value at the Beck Depression Inventory represent a worse outcome.
Post-traumatic stress disorder in women [1 year]
Change from Baseline in number of women with post-traumatic symptoms at 1 year after TToP assessed with the PTSD Checklist 5, which is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. PCL-5 cut-point of 33 appears to be a reasonable value to use for provisional PTSD diagnosis. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80 and a higher value represent a worse outcome

Secondary Outcome Measures

Depressive symptoms after TToP in men [1 year]
Change from Baseline in number of men with depressive symptoms at 1 year after TToP assessed with the Beck Depression Inventory, which measure the severity of depressive symptoms. The long form of the Beck Depression Inventory is composed of 21 questions or items, each with four possible responses. Each response is assigned a score ranging from zero to three, indicating the severity of the symptom. The sum of all item scores indicates the severity of depression. Scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression. So, a higher value at the Beck Depression Inventory represent a worse outcome.
Post-traumatic stress disorder after TToP in men [1 year]
Change from Baseline in number of men with post-traumatic symptoms at 1 year after TToP assessed with the PTSD Checklist 5 (PCL-5), which is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. PCL-5 cut-point of 33 appears to be a reasonable value to use for provisional PTSD diagnosis. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80 and a higher value represent a worse outcome
Participants with personality disorder [1 year]
Number of participants with personality disorder assessed with the Iowa Personality Disorder Screen, which is a 11-item screening instrument used to evaluate the presence of a personality disorder. Each item is scored dichotomously by Yes/No, giving individual IPDS scores ranging from 0 to 11. A cut off>4 positive items indicates the presence of a personality disorder. A higher value represent a worse outcome
Participants with childhood trauma [1 year]
Number of participants with a childhood trauma assessed with the Childhood Trauma Questionnaire, which is a standardized, retrospective 28-item self-report inventory that measures the severity of different types of childhood trauma, producing five clinical subscales each comprised of five items: Emotional Abuse, Physical Abuse, Sexual Abuse, Emotional Neglect, Physical Neglect. Participants respond to each item in the context of "when you were growing up" and answer according to a five-point Likert scale ranging from "never" = 1 to "very often" = 5, producing scores of 5 to 25 for each trauma subscale. A cut off>5 points in every subscale indicates the presence of that particular traumatic experience. A higher score in every subscale represent a worse outcome and a more severe type of childhood trauma
Role of personality disorders on depressive symptoms after TToP [1 year]
Difference in number of patients with depressive symptoms assessed with the Beck Depression Inventory (BDI, previously described) between participants with a personality disorder (PD+ group) and participants without a personality disorder (PD- group). This difference will be assessed with a statistical analysis. A higher number of patients with depressive symptoms in one of the two groups represent a worse outcome in that group
Role of personality disorders on post-traumatic symptoms after TToP [1 year]
Difference in number of patients with post-traumatic symptoms assessed with the PTSD Checklist 5 (PCL-5, previously described) between participants with a personality disorder (PD+ group) and participants without a personality disorder (PD- group). This difference will be assessed with a statistical analysis. A higher number of patients with post-traumatic symptoms in one of the two groups represent a worse outcome in that group