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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

Tracking Information
First Submitted Date  ICMJE March 25, 2016
First Posted Date  ICMJE May 4, 2017
Last Update Posted Date May 20, 2020
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
Change of Points on Impact of event scale before and after Lifespan Integration treatment after a sexual trauma [ Time Frame: 5 +/- 3 days before treatment and 20 +/- 3 days after treatment ]
One treatment is given, and change is measured 20 +/- 3 days after treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2017)
  • Change of Points of GHQ12 [ Time Frame: 3 weeks ]
    General Health Questionnaire 12
  • Change of Points of Stressful Events Survey PTSD Short Scale (NSESS) [ Time Frame: 3 weeks ]
    Questionnaire
  • Self Rated Health and Sickness Questionnaire [ Time Frame: 3 weeks ]
    10 items on current symptoms of sickness
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
  • Change of Points of GHQ12 [ Time Frame: 5 +/- 3 days before treatment, 20 +/- 3 days after treatment and 6 months after first measure. ]
    General Health Questionnaire 12
  • Change of Points of Stressful Events Survey PTSD Short Scale (NSESS) [ Time Frame: 5 +/- 3 days before treatment and 20 +/- 3 days after treatment ]
    Questionnaire
  • Self Rated Health and Sickness Questionnaire [ Time Frame: 5 +/- 3 days before treatment, 20 +/- 3 days after treatment ]
    10 items on current symptoms of sickness
Current Other Pre-specified Outcome Measures
 (submitted: May 5, 2017)
  • 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.
  • Change of Points of Stressful Events Survey PTSD Short Scale (NSESS) [ Time Frame: 6 months ]
    Questionnaire
  • Self Rated Health and Sickness Questionnaire [ Time Frame: 6 months ]
    10 items on current symptoms of sickness
Original Other Pre-specified Outcome Measures
 (submitted: May 3, 2017)
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.
 
Descriptive Information
Brief Title  ICMJE Lifespan Integration After Sexual Trauma
Official Title  ICMJE Lifespan Integration After Sexual Trauma, a Randomized Treatment Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Symptoms of Post Traumatic Stress Disorder (PTSD)
Intervention  ICMJE Other: Lifespan Integration
A protocol based psychological treatment method
Study Arms  ICMJE
  • 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.
    Intervention: Other: Lifespan Integration
  • 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.
Publications * Rajan G, Wachtler C, Lee S, Wändell P, Philips B, Wahlström L, Svedin CG, Carlsson AC. A One-Session Treatment of PTSD After Single Sexual Assault Trauma. A Pilot Study of the WONSA MLI Project: A Randomized Controlled Trial. J Interpers Violence. 2020 Oct 21:886260520965973. doi: 10.1177/0886260520965973. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2020)
63
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2017)
100
Actual Study Completion Date  ICMJE May 2020
Actual Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03141047
Other Study ID Numbers  ICMJE 1001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Insamlingsstiftelsen Wonsa, World of No Sexual Abuse
Study Sponsor  ICMJE Insamlingsstiftelsen Wonsa, World of No Sexual Abuse
Collaborators  ICMJE Karolinska Institutet
Investigators  ICMJE
Principal Investigator: Axel C Carlsson, Docent Karolinska Institutet
PRS Account Insamlingsstiftelsen Wonsa, World of No Sexual Abuse
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP