Lifespan Integration After Sexual Trauma

NCT ID: NCT03141047

Last Updated: 2020-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2020-05-31

Brief Summary

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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

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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.

Conditions

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Symptoms of Post Traumatic Stress Disorder (PTSD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Lifespan Integration

Intervention Type OTHER

A protocol based psychological treatment method

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifespan Integration

A protocol based psychological treatment method

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Insamlingsstiftelsen Wonsa, World of No Sexual Abuse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Axel C Carlsson, Docent

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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World of no sexual abuse, Wonsa

Stockholm, Stortorget 3, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 33084475 (View on PubMed)

Other Identifiers

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1001

Identifier Type: -

Identifier Source: org_study_id

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