- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03141047
Lifespan Integration After Sexual Trauma
May 19, 2020 updated by: Insamlingsstiftelsen Wonsa, World of No Sexual Abuse
Lifespan Integration After Sexual Trauma, a Randomized Treatment Study
A new psychological trauma treatment method is tested on a population (n 100) of adult women who have been sexually traumatized at one specific time 0-5 years before they enter the study.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
One treatment session is given with the psychological treatment method Lifespan Integration (LI).
The main outcome is change on Impact of Event Scale (IES) before and after the treatment.
The change is analyzed and compared with the change on Impact of Event Scale (IES) among the people on the waiting list arm.
Self-rating questionnaires are being used 5+/-3 days before treatment, 20 +/-3 days after treatment, and 6 months +/- 6 weeks after the first measurement.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Stortorget 3
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Stockholm, Stortorget 3, Sweden, 11129
- World of no sexual abuse, Wonsa
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 100 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Sexual trauma 1-5 years before inclusion
- understanding Swedish, read and spoken
Exclusion Criteria:
- Psychotic symptoms
- drug abuse
- neuropsychiatric diagnoses ADHD and asperger
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifespan Integration
This arm is given one session of Lifespan Integration.
Differences on Impact of Event Scale from the first measurement at inclusion and the second measurement 20 +/- 3 days after the first measurement, and after treatment, is analyzed and compared with the results from the Group on waiting list.
A third measurement and comparison is being made 6 months +/- 6 weeks after the first measurement at inclusion.
|
A protocol based psychological treatment method
|
No Intervention: Waiting list
This arm gets no treatment, and differences on Impact of Event Scale from the first measurement at inclusion at the second measurement 20 +/- 3 days after, without treatment, is analyzed and compared with the results from the treatment Group.
A third measurement and comparison is being made 6 months +/- 6 week after the first measurement at inclusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Points on Impact of event scale before and after Lifespan Integration treatment after a sexual trauma
Time Frame: 3 weeks
|
One treatment is given, and change is measured 20 +/- 3 days after treatment.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Points of GHQ12
Time Frame: 3 weeks
|
General Health Questionnaire 12
|
3 weeks
|
Change of Points of Stressful Events Survey PTSD Short Scale (NSESS)
Time Frame: 3 weeks
|
Questionnaire
|
3 weeks
|
Self Rated Health and Sickness Questionnaire
Time Frame: 3 weeks
|
10 items on current symptoms of sickness
|
3 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Points on Impact of event scale before and after Lifespan Integration treatment
Time Frame: 6 months
|
One treatment is given, and change is measured two weeks after treatment and six months after treatment.
|
6 months
|
Change of Points of Stressful Events Survey PTSD Short Scale (NSESS)
Time Frame: 6 months
|
Questionnaire
|
6 months
|
Self Rated Health and Sickness Questionnaire
Time Frame: 6 months
|
10 items on current symptoms of sickness
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Axel C Carlsson, Docent, Karolinska Institutet
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
May 1, 2020
Study Completion (Actual)
May 1, 2020
Study Registration Dates
First Submitted
March 25, 2016
First Submitted That Met QC Criteria
May 3, 2017
First Posted (Actual)
May 4, 2017
Study Record Updates
Last Update Posted (Actual)
May 20, 2020
Last Update Submitted That Met QC Criteria
May 19, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1001 (Registro Nacional Estudios Clinicos (RNEC))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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