Early Psychological Intervention After Rape

Post Traumatic Stress Disorder Clinical Trial

— EIR  

Official title:

Early Intervention After Rape to Prevent Post-traumatic Stress Disorder - a Multicenter Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05489133
• Other study ID #: 348496
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2022
• Est. completion date: December 2027

Study information

• Verified date: June 2024
• Source: St. Olavs Hospital
• Contact: Cecilie T Hagemann, PhD
• Phone: 95829490
• Email: cecilie.hagemann[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2027
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Activity, Motor
• Cortisol Deficiency
• Depression, Anxiety
• Myalgia
• Pelvic Pain
• Pelvic Pain Syndrome
• Post Traumatic Stress Disorder
• Rape Sexual Assault
• Sexual Dysfunctions, Psychological
• Sleep Disturbance
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Vaginismus

Intervention

Behavioral:
• Modified prolonged exposure
Imaginary and in vivo expo, in addition to psychoeducation

Locations

Country	Name	City	State
Norway	Oslo Emergency Medical Agency (Oslo kommune, Legevakten, Overgrepsmottaket i Oslo)	Oslo
Norway	Sandefjord Emergency Medical Agency (Legevakten, Overgrepsmottaket i Vestfold)	Sandefjord
Norway	Overgrepsmottaket Sør-Rogaland	Stavanger	In
Norway	Department of Obstetrics and Gynecology, St. Olavs hospital (Overgrepsmottaket)	Trondheim

Sponsors (6)

Lead Sponsor	Collaborator
St. Olavs Hospital	National Centre for Emergency Primary Health Care, NORCE, Norwegian University of Science and Technology, Norwegian Women's Public Health Association (Norske Kvinners Sanitetsforening), The Research Council of Norway, UiT The Arctic University of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 3 months follow-up
Primary	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.	At 3 months follow-up
Secondary	Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 is a self-report questionnaire consisting of nine items measuring the severity of depressive symptoms.	At 6 weeks, 3, 6 and 12 months
Secondary	General Anxiety Disorder-7 (GAD-7)	GAD-7 is a self-report questionnaire consisting of seven items measuring the severity of symptoms of anxiety.	At 6 weeks, 3, 6 and 12 months
Secondary	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.	At 6 weeks, 3, 6 and 12 months
Secondary	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	At 6 weeks, 3, 6 and 12 months
Secondary	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.	At 6 weeks, 3, 6 and 12 months
Secondary	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.	At 6 weeks, 3, 6 and 12 months
Secondary	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.	At 6 weeks, 3, 6 and 12 months
Secondary	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.	At 6 weeks, 3, 6 and 12 months