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Trial record 1 of 1 for:    NCT03141047
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Lifespan Integration After Sexual Trauma

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ClinicalTrials.gov Identifier: NCT03141047
Recruitment Status : Completed
First Posted : May 4, 2017
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Insamlingsstiftelsen Wonsa, World of No Sexual Abuse

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Symptoms of Post Traumatic Stress Disorder (PTSD) Other: Lifespan Integration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lifespan Integration After Sexual Trauma, a Randomized Treatment Study
Actual Study Start Date : March 2016
Actual Primary Completion Date : May 2020
Actual Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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.
Other: Lifespan Integration
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change of Points of GHQ12 [ Time Frame: 3 weeks ]
    General Health Questionnaire 12

  2. Change of Points of Stressful Events Survey PTSD Short Scale (NSESS) [ Time Frame: 3 weeks ]
    Questionnaire

  3. Self Rated Health and Sickness Questionnaire [ Time Frame: 3 weeks ]
    10 items on current symptoms of sickness


Other Outcome Measures:
  1. 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.

  2. Change of Points of Stressful Events Survey PTSD Short Scale (NSESS) [ Time Frame: 6 months ]
    Questionnaire

  3. Self Rated Health and Sickness Questionnaire [ Time Frame: 6 months ]
    10 items on current symptoms of sickness



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141047


Locations
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Sweden
World of no sexual abuse, Wonsa
Stockholm, Stortorget 3, Sweden, 11129
Sponsors and Collaborators
Insamlingsstiftelsen Wonsa, World of No Sexual Abuse
Karolinska Institutet
Investigators
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Principal Investigator: Axel C Carlsson, Docent Karolinska Institutet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Insamlingsstiftelsen Wonsa, World of No Sexual Abuse
ClinicalTrials.gov Identifier: NCT03141047    
Other Study ID Numbers: 1001
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Keywords provided by Insamlingsstiftelsen Wonsa, World of No Sexual Abuse:
Sexual trauma, Lifespan Integration
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders