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Lifespan Integration After Sexual Trauma

Primary Purpose

Symptoms of Post Traumatic Stress Disorder (PTSD)

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Lifespan Integration
Sponsored by
Insamlingsstiftelsen Wonsa, World of No Sexual Abuse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptoms of Post Traumatic Stress Disorder (PTSD) focused on measuring Sexual trauma, Lifespan Integration

Eligibility Criteria

15 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • World of no sexual abuse, Wonsa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifespan Integration

Waiting list

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of Points on Impact of event scale before and after Lifespan Integration treatment after a sexual trauma
One treatment is given, and change is measured 20 +/- 3 days after treatment.

Secondary Outcome Measures

Change of Points of GHQ12
General Health Questionnaire 12
Change of Points of Stressful Events Survey PTSD Short Scale (NSESS)
Questionnaire
Self Rated Health and Sickness Questionnaire
10 items on current symptoms of sickness

Full Information

First Posted
March 25, 2016
Last Updated
May 19, 2020
Sponsor
Insamlingsstiftelsen Wonsa, World of No Sexual Abuse
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03141047
Brief Title
Lifespan Integration After Sexual Trauma
Official Title
Lifespan Integration After Sexual Trauma, a Randomized Treatment Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insamlingsstiftelsen Wonsa, World of No Sexual Abuse
Collaborators
Karolinska Institutet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptoms of Post Traumatic Stress Disorder (PTSD)
Keywords
Sexual trauma, Lifespan Integration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifespan Integration
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Lifespan Integration
Intervention Description
A protocol based psychological treatment method
Primary Outcome Measure Information:
Title
Change of Points on Impact of event scale before and after Lifespan Integration treatment after a sexual trauma
Description
One treatment is given, and change is measured 20 +/- 3 days after treatment.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Change of Points of GHQ12
Description
General Health Questionnaire 12
Time Frame
3 weeks
Title
Change of Points of Stressful Events Survey PTSD Short Scale (NSESS)
Description
Questionnaire
Time Frame
3 weeks
Title
Self Rated Health and Sickness Questionnaire
Description
10 items on current symptoms of sickness
Time Frame
3 weeks
Other Pre-specified Outcome Measures:
Title
Change of Points on Impact of event scale before and after Lifespan Integration treatment
Description
One treatment is given, and change is measured two weeks after treatment and six months after treatment.
Time Frame
6 months
Title
Change of Points of Stressful Events Survey PTSD Short Scale (NSESS)
Description
Questionnaire
Time Frame
6 months
Title
Self Rated Health and Sickness Questionnaire
Description
10 items on current symptoms of sickness
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel C Carlsson, Docent
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
World of no sexual abuse, Wonsa
City
Stockholm
State/Province
Stortorget 3
ZIP/Postal Code
11129
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
33084475
Citation
Rajan G, Wachtler C, Lee S, Wandell P, Philips B, Wahlstrom 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. 2022 May;37(9-10):NP6582-NP6603. doi: 10.1177/0886260520965973. Epub 2020 Oct 21.
Results Reference
derived

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Lifespan Integration After Sexual Trauma

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