Lifespan Integration After Sexual Trauma

Symptoms of Post Traumatic Stress Disorder (PTSD) Clinical Trial

Official title:

Lifespan Integration After Sexual Trauma, a Randomized Treatment Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141047
• Other study ID #: 1001
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: May 2020

Study information

• Verified date: May 2020
• Source: Insamlingsstiftelsen Wonsa, World of No Sexual Abuse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Symptoms of Post Traumatic Stress Disorder (PTSD)

Intervention

Other:
• Lifespan Integration
A protocol based psychological treatment method

Locations

Country	Name	City	State
Sweden	World of no sexual abuse, Wonsa	Stockholm	Stortorget 3

Sponsors (2)

Lead Sponsor	Collaborator
Insamlingsstiftelsen Wonsa, World of No Sexual Abuse	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of Points on Impact of event scale before and after Lifespan Integration treatment	One treatment is given, and change is measured two weeks after treatment and six months after treatment.	6 months
Other	Change of Points of Stressful Events Survey PTSD Short Scale (NSESS)	Questionnaire	6 months
Other	Self Rated Health and Sickness Questionnaire	10 items on current symptoms of sickness	6 months
Primary	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.	3 weeks
Secondary	Change of Points of GHQ12	General Health Questionnaire 12	3 weeks
Secondary	Change of Points of Stressful Events Survey PTSD Short Scale (NSESS)	Questionnaire	3 weeks
Secondary	Self Rated Health and Sickness Questionnaire	10 items on current symptoms of sickness	3 weeks