Post Traumatic Stress DisorderNCT03887689
Early Psychological Intervention After Rape
A study testing Modified prolonged exposure in people with Post Traumatic Stress Disorder, run by Karolinska Institutet.
Trial summary
The aim of the study is to translate and adapt a brief treatment protocol based on prolonged exposure provided within 72 hours after a rape to a Swedish context and pilot test feasibility and delivery in ten executive patients recruited at the Emergency Clinic for Rape victims in Stockholm. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Modified prolonged exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 11 Jan 2017to 4 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Attending at the Emergency Clinic for Rape victims at Stockholm South Hospital, Sweden within 72 hours after experiencing a rape)
- Remembered the event.
Who cannot join
- ongoing suicidal ideation or attempted suicide within the last two months
- ongoing self-harm behavior
- ongoing intoxication
- other serious psychiatric comorbidity (ongoing psychotic symptoms or manic episode)
- low cognitive capacity
- not fluent in Swedish
- subjected to ongoing violence or threat
About this study
Official title: Early Psychological Intervention After Rape: a Feasibility Study
The aim of the study is to translate and adapt a brief treatment protocol based on prolonged exposure provided within 72 hours after a rape to a Swedish context and pilot test feasibility and delivery in ten executive patients recruited at the Emergency Clinic for Rape victims in Stockholm.
Read the detailed description
The aim of the study is to translate and adapt a brief treatment protocol based on prolonged exposure provided within 72 hours after a rape to a Swedish context and pilot test feasibility and delivery in ten executive patients recruited at the Emergency Clinic for Rape victims in Stockholm.
ENDPOINTS The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), Beck Depression Inventory (BDI) at baseline and post-treatment.
Insomnia Severity Index (ISI) , Multidimensional Scale of Perceived Social Support (MSPSS), World Health Organization Disability Assessment Schedule(WHODAS-12) at post-treatment.The clinician-administered PTSD scale for DSM-5 (CAPS-5) at follow up.
Data on feasibility aspects of the intervention will also be collected: compliance to the intervention/homework/assessments, possibilities to recruit, adverse events.
Recruitment The investigatorors will recruit ten consecutive patients attending at the Emergency Clinic for Rape victims at Stockholm South Hospital, Sweden.
Safety parameters Participants had the opportunity to report any adverse events during treatment, at posttreatment and follow-up.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Modified prolonged exposure
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified prolonged exposureBehavioural
Participants will receive three sessions of modified prolonged exposure therapy.
| Study group | Role | What they receive |
|---|---|---|
| Modified prolonged exposure | Experimental | Participants will receive three sessions of modified prolonged exposure therapy. Receives: Behavioral: Modified prolonged exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD
Measured: Change 2 months (primary endpoint) after intervention
Secondary outcomes (7)
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
Change in symptoms of post traumatic stress from post treatment and follow up (2 months). The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. All items are scored on a 0-4 scale. Higher score indicate worse severity.
Measured: Change 2 months after intervention
Beck Depression Inventory (BDI)
Change in depressive symptoms from baseline to post treatment and follow up (2 months). The BDI is a 21 item self-report measure that assesses the presence and severity of depressive symptoms. All items are scored on a 0-3 scale. Higher score indicate worse severity.
Measured: Change 2 months after intervention
Adverse Events
Number of adverse events from baseline to follow up 2 months
Measured: Change 2 months after intervention
WHO Disability Assessment Schedule (WHODAS)
Measure of general health and function. The WHODAS-12 is a 12 item self-report measure that assesses overall health and functioning. All items are scored on a 0-4 scale. Higher score indicate worse severity.
Measured: Change 2 months after intervention
Insomnia Severity Index (ISI)
Self-report questionnaire regarding insomnia. The ISI is a 12 item self-report measure that assesses sleep quality. All items are scored on a 0-4 scale. Higher score indicate worse severity.
Measured: Change 2 months after intervention
Multidimensional Scale of Perceived Social Support (MSPSS)
A measure to assess for social support. MSPSS is a 7 item self-report measure that assesses aspects of social support. All items are scored on a 0-7 scale. Lower score indicate worse severity.
Measured: Change 2 months after intervention
Intrusion diary
Change in self-report assessment of daily intrusions using a pen and stencil diary.
Measured: Change at week 1, week 2 and week 3 of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start11 Jan 2017
- Primary completion4 Apr 2017
- Study completion4 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Andersson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887689
- Sponsor's protocol ID
- 2016/2194-31
- Status last verified
- Aug 2019
- First submitted
- 21 Mar 2019
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Psychological Intervention After Rape: a Feasibility Study
- ClinicalTrials.gov ID
- NCT03887689
- Acronym / sponsor ID
- 2016/2194-31
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 4 Apr 2017 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to translate and adapt a brief treatment protocol based on prolonged exposure provided within 72 hours after a rape to a Swedish context and pilot test feasibility and delivery in ten executive patients recruited at the Emergency Clinic for Rape victims in Stockholm.
Detailed description
The aim of the study is to translate and adapt a brief treatment protocol based on prolonged exposure provided within 72 hours after a rape to a Swedish context and pilot test feasibility and delivery in ten executive patients recruited at the Emergency Clinic for Rape victims in Stockholm.
ENDPOINTS The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), Beck Depression Inventory (BDI) at baseline and post-treatment.
Insomnia Severity Index (ISI) , Multidimensional Scale of Perceived Social Support (MSPSS), World Health Organization Disability Assessment Schedule(WHODAS-12) at post-treatment.The clinician-administered PTSD scale for DSM-5 (CAPS-5) at follow up.
Data on feasibility aspects of the intervention will also be collected: compliance to the intervention/homework/assessments, possibilities to recruit, adverse events.
Recruitment The investigatorors will recruit ten consecutive patients attending at the Emergency Clinic for Rape victims at Stockholm South Hospital, Sweden.
Safety parameters Participants had the opportunity to report any adverse events during treatment, at posttreatment and follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified prolonged exposure | Experimental | Behavioral: Modified prolonged exposureParticipants will receive three sessions of modified prolonged exposure therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Attending at the Emergency Clinic for Rape victims at Stockholm South Hospital, Sweden within 72 hours after experiencing a rape)
- Remembered the event.
Key exclusion criteria (7 listed)
- ongoing suicidal ideation or attempted suicide within the last two months
- ongoing self-harm behavior
- ongoing intoxication
- other serious psychiatric comorbidity (ongoing psychotic symptoms or manic episode)
- low cognitive capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified prolonged exposureParticipants will receive three sessions of modified prolonged exposure therapy. | Behavioural | Modified prolonged exposure |
Primary outcome
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
Time frame: Change 2 months (primary endpoint) after intervention
Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD
7 secondary outcomes
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
Time frame: Change 2 months after intervention
Beck Depression Inventory (BDI)
Time frame: Change 2 months after intervention
Adverse Events
Time frame: Change 2 months after intervention
WHO Disability Assessment Schedule (WHODAS)
Time frame: Change 2 months after intervention
Insomnia Severity Index (ISI)
Time frame: Change 2 months after intervention
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Change 2 months after intervention
Intrusion diary
Time frame: Change at week 1, week 2 and week 3 of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Modified prolonged exposure in people with Post Traumatic Stress Disorder, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS) (time frame: Change 2 months (primary endpoint) after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.