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Early Psychological Intervention After Rape (EIR)

Primary Purpose

Post Traumatic Stress Disorder, Rape Sexual Assault, Sexual Dysfunctions, Psychological

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Modified prolonged exposure
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Traumatic Stress Disorder

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women ≥ 16 years of age
  • attending after a trauma meeting the DSM V trauma definition criterion "sexual violation" (in this context, characterized by penetration in any body orifice, by penis, finger, foreign body, but also attempted penetration leading to a sufficient mental reaction, helplessness, without control, intense fear etc.)

Exclusion Criteria:

  • Age < 16 years
  • male biological gender
  • cognitive disability
  • acute psychosis
  • acute suicidal
  • severe alcohol/drug abuse
  • current treatment for PTSD
  • non-Norwegian speaking
  • total amnesia for the event

Sites / Locations

  • Oslo Emergency Medical Agency (Oslo kommune, Legevakten, Overgrepsmottaket i Oslo)
  • Sandefjord Emergency Medical Agency (Legevakten, Overgrepsmottaket i Vestfold)
  • Department of Obstetrics and Gynecology, St. Olavs hospital (Overgrepsmottaket)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Modified prolonged exposure (add on)

Treatment as usual (TAU)

Arm Description

The psychological intervention modified Prolonged Exposure Therapy (mPE) is applied, in addition to Treatment as usual (TAU) (that is, an Add-on). mPE is a trauma-focused evidence-based cognitive behavioral therapy (CBT) shown to be effective in treating PTSD. We will use imaginal exposure in the sessions with the patient describing the traumatic event in detail while being recorded for later listening and homework, and in vivo exposure for visiting specific places or people. Psychoeducation and controlled breathing exercises play a secondary role in PE. We have adapted the mPE to the current SAC settings in Norway where nurses or social workers, not psychologist, as a rule are performing the psychosocial follow-up for rape victims. In this project we plan for three to five once or twice weekly nurse-/social worker-led mPE interventions, given early after the assault.

Standard care at the sexual assault center (SAC), that is mostly nurse-/social worker-led psychoeducation at varying intervals and extent, and medical follow-up at the SAC.

Outcomes

Primary Outcome Measures

PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a self-report questionnaire consisting of 20 items corresponding to the 20 symptoms of PTSD as defined by DSM-5. Patients rate their posttraumatic symptoms on a Likert scale from 0-4. The continuous sum score of the PCL-5 will de the primary outcome.
PTSD Symptom Scale - Interview for DSM-5 (PSS-I-5)
The PSS-I-5 is a clinician-administered diagnostic interview measuring the 20 symptoms of PTSD as defined by DSM-5.

Secondary Outcome Measures

Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a self-report questionnaire consisting of nine items measuring the severity of depressive symptoms.
General Anxiety Disorder-7 (GAD-7)
GAD-7 is a self-report questionnaire consisting of seven items measuring the severity of symptoms of anxiety.
Female Sexual Function Index (FSFI)
The FSFI is a multidimensional self-report instrument for the assessment of female sexual function. It contains 19 items divided into six subscales, and gives a total score of 2-36 by multiplying the sum of each subscale with a factor. Mapi Research Trust, a non-profit, full-service provider, promoting the use of Clinical Outcomes Assessments (COAs) have given us permission to use the Norwegian version of the FSFI questionnaire in our study, a version we consider better than the one available on the FHI web-pages.
Bergen insomnia scale (BIS)
Insomnia, questionnaire, quantitative, continous measure. The questionnaire contains 6 items relating to sleep and tiredness. Score 0 -7 (0 means no days during the course of a week, 7 means every day during the course of a week) on each item are summarized. Diagnostics for Insomnia: score ≥ 3 on at least one of the items 1 -4, and score ≥ 3 on at least one of the items 5-6) vs. No insomnia: score ≤ 2 on all items 1-4 or score ≤ 2 on both items 5-6
EQ-5D-5L
Quality of life: five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems (each scored 1-5). Included also is the EQ VAS that records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine' (0-100). The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
The Amsterdam Hyperactive Pelvic Floor Scale for Women
Questionnaire, translated and validated Norwegian version: The original questionnaire includes 30 items. Each item deals with one symptom and has a 5-point Likert scale varying from never (score 1) to very often (score 5). 25 of the 30 items are categorized into six different subscales: 1) vulvar pain symptoms; 2) abdominal pain and defecation symptoms; 3) micturition problems; 4) urinary tract infection; 5) rectal problems; and 6) physiological symptoms of general stress/tension. A total score is given from 6 to 30 where a low score (6,0 - 10,9) means "no hyperactivity" in the pelvic floor muscles, a medium score (11,0 - 12,9) means "mild hyperactivity" in the pelvic floor and a high score (13,0 - 30,0) means "moderate to severe hyperactivity" in the pelvic floor.
PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a self-report questionnaire consisting of 20 items corresponding to the 20 symptoms of PTSD as defined by DSM-5. Patients rate their posttraumatic symptoms on a Likert scale from 0-4. The continuous sum score of the PCL-5 will de the primary outcome.
PTSD Symptom Scale - Interview for DSM-5 (PSS-I-5)
The PSS-I-5 is a clinician-administered diagnostic interview measuring the 20 symptoms of PTSD as defined by DSM-5.

Full Information

First Posted
July 15, 2022
Last Updated
October 10, 2022
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, The Research Council of Norway, Norwegian Women's Public Health Association (Norske Kvinners Sanitetsforening), National Centre for Emergency Primary Health Care, NORCE, UiT The Arctic University of Norway
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1. Study Identification

Unique Protocol Identification Number
NCT05489133
Brief Title
Early Psychological Intervention After Rape
Acronym
EIR
Official Title
Early Intervention After Rape to Prevent Post-traumatic Stress Disorder - a Multicenter Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, The Research Council of Norway, Norwegian Women's Public Health Association (Norske Kvinners Sanitetsforening), National Centre for Emergency Primary Health Care, NORCE, UiT The Arctic University of Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Rape is a common cause of post-traumatic stress disorder (PTSD) among women, as around 30-50% will develop PTSD in the aftermath of rape. A modified protocol based on Prolonged Exposure Therapy (mPE), has been developed, consisting of three to five once or twice weekly 60 minutes sessions, and studies indicate that if implemented early after rape, mPE may prevent the development of PTSD. The aim of the study is to conduct a multi-site (4 Sexual assault care centers in Norway) randomized control trial (RCT) in which patients are recruited early after rape, and randomized to intervention (mPE) or treatment as usual (TAU).
Detailed Description
Rape is a common cause of post-traumatic stress disorder (PTSD) among women, as around 30-50% will develop PTSD in the aftermath of rape, leading to severe mental and physical suffering. There is a lack of evidence-based knowledge how to prevent the development of PTSD after rape. Women may suffer from PTSD for years before receiving therapy. Prolonged Exposure Therapy (PE) is well documented as a therapy. However, preventing the development of PTSD have the potential to spare women of the suffering, prevent both mental and somatic health problems, and also reduce health care costs. Currently a brief protocol based on PE, has been developed, modified prolonged exposure (mPE), consisting of three to five once or twice weekly 60 minutes sessions, and studies indicate that if implemented early after rape, mPE may prevent the development of PTSD. Specialized services for victims, Sexual Assault Care (SAC) centers have been established in Norway, offering forensic documentation, medical treatment and psychosocial follow-up. The follow-up service varies widely and no evidence-based preventive measures have been implemented. The investigators propose to conduct a multi-site (SAC centers in Trondheim, Oslo, and Sandefjord) randomized control trial (RCT) in which patients are recruited early after a rape, and randomized within 2 weeks to intervention (mPE) or treatment as usual (TAU). The patients will be stratified by treatment center and randomized in permuted blocks of varying sizes according to a computer-generated randomization key prepared by the Clinical Research Unit at . Around 800 patients will attend one of the four SACs per year. Based on experience from others the investigators anticipate that approximately 200 patients will be eligible and consenting to participation in this study and that around 50% of participants will dropout during the study period. A final sample size of 100 completed participants (50 in the intervention and 50 in TAU) will achieve 80% power to detect a standardized mean difference (SMD) of 0.44 for each of the primary outcomes in a design with 3 repeated measurements assuming an autoregressive, AR(1), covariance structure when the standard deviation is 1, the correlation between observations on the same subject is 0.5, and the alpha level is 0.05 (PASS Sample Size software - Tests for Two Means in Repeated Measures Design). Given the rather conservative estimate for inclusion, the investigators will need 1.5-2 years to recruit sufficient numbers. Given the nested structure of the data - e.g., multiple measurement points nested within patients, patients nested within therapists, therapists nested within study sites - data will be analyzed by multilevel modeling. In addition, multilevel modeling is a robust method to deal with the missing data given the expected high percentage of drop-out from the study. The primary analysis will be an intention-to-treat analysis. Predictors and moderators of the intervention, like stress response (measured by level of cortisol in hair and saliva) and sleep patterns (measured with actigraphy), will be explored. The planned intervention is a brief and simple program, with large potential to be implemented as routines if proven effective, and thus inform clinical guidelines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Rape Sexual Assault, Sexual Dysfunctions, Psychological, Pelvic Floor Myalgia, Pelvic Pain Syndrome, Depression, Anxiety, Sleep Disturbance, Activity, Motor, Cortisol Deficiency

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Primary objective is to test whether a psychological intervention with modified prolonged exposure (mPE) therapy is superior to treatment as usual (TAU) to prevent the development of PTSD.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified prolonged exposure (add on)
Arm Type
Experimental
Arm Description
The psychological intervention modified Prolonged Exposure Therapy (mPE) is applied, in addition to Treatment as usual (TAU) (that is, an Add-on). mPE is a trauma-focused evidence-based cognitive behavioral therapy (CBT) shown to be effective in treating PTSD. We will use imaginal exposure in the sessions with the patient describing the traumatic event in detail while being recorded for later listening and homework, and in vivo exposure for visiting specific places or people. Psychoeducation and controlled breathing exercises play a secondary role in PE. We have adapted the mPE to the current SAC settings in Norway where nurses or social workers, not psychologist, as a rule are performing the psychosocial follow-up for rape victims. In this project we plan for three to five once or twice weekly nurse-/social worker-led mPE interventions, given early after the assault.
Arm Title
Treatment as usual (TAU)
Arm Type
No Intervention
Arm Description
Standard care at the sexual assault center (SAC), that is mostly nurse-/social worker-led psychoeducation at varying intervals and extent, and medical follow-up at the SAC.
Intervention Type
Behavioral
Intervention Name(s)
Modified prolonged exposure
Other Intervention Name(s)
Brief intervention, cognitive behavioral therapy
Intervention Description
Imaginary and in vivo expo, in addition to psychoeducation
Primary Outcome Measure Information:
Title
PTSD Checklist for DSM-5 (PCL-5)
Description
The PCL-5 is a self-report questionnaire consisting of 20 items corresponding to the 20 symptoms of PTSD as defined by DSM-5. Patients rate their posttraumatic symptoms on a Likert scale from 0-4. The continuous sum score of the PCL-5 will de the primary outcome.
Time Frame
At 3 months follow-up
Title
PTSD Symptom Scale - Interview for DSM-5 (PSS-I-5)
Description
The PSS-I-5 is a clinician-administered diagnostic interview measuring the 20 symptoms of PTSD as defined by DSM-5.
Time Frame
At 3 months follow-up
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
The PHQ-9 is a self-report questionnaire consisting of nine items measuring the severity of depressive symptoms.
Time Frame
At 6 weeks, 3, 6 and 12 months
Title
General Anxiety Disorder-7 (GAD-7)
Description
GAD-7 is a self-report questionnaire consisting of seven items measuring the severity of symptoms of anxiety.
Time Frame
At 6 weeks, 3, 6 and 12 months
Title
Female Sexual Function Index (FSFI)
Description
The FSFI is a multidimensional self-report instrument for the assessment of female sexual function. It contains 19 items divided into six subscales, and gives a total score of 2-36 by multiplying the sum of each subscale with a factor. Mapi Research Trust, a non-profit, full-service provider, promoting the use of Clinical Outcomes Assessments (COAs) have given us permission to use the Norwegian version of the FSFI questionnaire in our study, a version we consider better than the one available on the FHI web-pages.
Time Frame
At 6 weeks, 3, 6 and 12 months
Title
Bergen insomnia scale (BIS)
Description
Insomnia, questionnaire, quantitative, continous measure. The questionnaire contains 6 items relating to sleep and tiredness. Score 0 -7 (0 means no days during the course of a week, 7 means every day during the course of a week) on each item are summarized. Diagnostics for Insomnia: score ≥ 3 on at least one of the items 1 -4, and score ≥ 3 on at least one of the items 5-6) vs. No insomnia: score ≤ 2 on all items 1-4 or score ≤ 2 on both items 5-6
Time Frame
At 6 weeks, 3, 6 and 12 months
Title
EQ-5D-5L
Description
Quality of life: five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems (each scored 1-5). Included also is the EQ VAS that records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine' (0-100). The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Time Frame
At 6 weeks, 3, 6 and 12 months
Title
The Amsterdam Hyperactive Pelvic Floor Scale for Women
Description
Questionnaire, translated and validated Norwegian version: The original questionnaire includes 30 items. Each item deals with one symptom and has a 5-point Likert scale varying from never (score 1) to very often (score 5). 25 of the 30 items are categorized into six different subscales: 1) vulvar pain symptoms; 2) abdominal pain and defecation symptoms; 3) micturition problems; 4) urinary tract infection; 5) rectal problems; and 6) physiological symptoms of general stress/tension. A total score is given from 6 to 30 where a low score (6,0 - 10,9) means "no hyperactivity" in the pelvic floor muscles, a medium score (11,0 - 12,9) means "mild hyperactivity" in the pelvic floor and a high score (13,0 - 30,0) means "moderate to severe hyperactivity" in the pelvic floor.
Time Frame
At 6 weeks, 3, 6 and 12 months
Title
PTSD Checklist for DSM-5 (PCL-5)
Description
The PCL-5 is a self-report questionnaire consisting of 20 items corresponding to the 20 symptoms of PTSD as defined by DSM-5. Patients rate their posttraumatic symptoms on a Likert scale from 0-4. The continuous sum score of the PCL-5 will de the primary outcome.
Time Frame
At 6 weeks, 3, 6 and 12 months
Title
PTSD Symptom Scale - Interview for DSM-5 (PSS-I-5)
Description
The PSS-I-5 is a clinician-administered diagnostic interview measuring the 20 symptoms of PTSD as defined by DSM-5.
Time Frame
At 6 weeks, 3, 6 and 12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Many of the vaildated questionnaires are based on the presence of female genital organs, hence, we have chosen to include only genetical and phenotypical females
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women ≥ 16 years of age attending after a trauma meeting the DSM V trauma definition criterion "sexual violation" (in this context, characterized by penetration in any body orifice, by penis, finger, foreign body, but also attempted penetration leading to a sufficient mental reaction, helplessness, without control, intense fear etc.) Exclusion Criteria: Age < 16 years male biological gender cognitive disability acute psychosis acute suicidal severe alcohol/drug abuse current treatment for PTSD non-Norwegian speaking total amnesia for the event
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilie T Hagemann, PhD
Phone
95829490
Ext
+47
Email
cecilie.hagemann@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Joar Ø Halvorsen, PhD
Phone
92256656
Ext
+47
Email
joar.halvorsen@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilie T Hagemann
Organizational Affiliation
St. Olavs Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joar Ø Halvorsen
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Oslo Emergency Medical Agency (Oslo kommune, Legevakten, Overgrepsmottaket i Oslo)
City
Oslo
ZIP/Postal Code
0182
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tone Jeksrud, Master
Phone
+4745295360
Email
tone.jeksrud@hel.oslo.kommune.no
First Name & Middle Initial & Last Name & Degree
Anne B Lunde
Email
anne.berit.lunde@hel.oslo.kommune.no
Facility Name
Sandefjord Emergency Medical Agency (Legevakten, Overgrepsmottaket i Vestfold)
City
Sandefjord
ZIP/Postal Code
3247
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda M Gustavsen
Phone
+4797596797
Email
linda.molgaard.gustavsen@sandefjord.kommune.no
First Name & Middle Initial & Last Name & Degree
Ruth C Grude
Email
Ruth.Cecilie.Grude@sandefjord.kommune.no
Facility Name
Department of Obstetrics and Gynecology, St. Olavs hospital (Overgrepsmottaket)
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilie Hagemann, PhD
Phone
+4795829490
Email
cecilie.hagemann@ntnu.no
First Name & Middle Initial & Last Name & Degree
Coordinator
Phone
+4748117289
Email
EIRstudien@stolav.no

12. IPD Sharing Statement

Plan to Share IPD
No

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Early Psychological Intervention After Rape

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