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

Conditions

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

  • Sweden
    • Stortorget 3
      • Stockholm, Stortorget 3, Sweden, 11129
        • World of no sexual abuse, Wonsa

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.
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.

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.

Sponsor

Insamlingsstiftelsen Wonsa, World of No Sexual Abuse

Collaborators

Karolinska Institutet

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.

General Publications

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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