Symptoms of Post Traumatic Stress Disorder (PTSD)NCT03141047
Lifespan Integration After Sexual Trauma
A study testing Lifespan Integration in people with Symptoms of Post Traumatic Stress Disorder (PTSD), run by Insamlingsstiftelsen Wonsa, World of No Sexual Abuse at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Symptoms of Post Traumatic Stress Disorder (PTSD)
- What is being tested?
- Lifespan Integration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2016to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sexual trauma 1-5 years before inclusion
- understanding Swedish, read and spoken
Who cannot join
- Psychotic symptoms
- drug abuse
- neuropsychiatric diagnoses ADHD and asperger
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Lifespan Integration
- Keywords
- Sexual trauma, Lifespan Integration
- Medical subject headings
- Sexual Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifespan IntegrationOther
A protocol based psychological treatment method
| Study group | Role | What they receive |
|---|---|---|
| Lifespan Integration | Experimental | 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. Receives: Other: Lifespan Integration |
| Waiting list | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (3)
Change of Points of GHQ12
General Health Questionnaire 12
Measured: 3 weeks
Change of Points of Stressful Events Survey PTSD Short Scale (NSESS)
Questionnaire
Measured: 3 weeks
Self Rated Health and Sickness Questionnaire
10 items on current symptoms of sickness
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study startMar 2016
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptoms of Post Traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insamlingsstiftelsen Wonsa, World of No Sexual Abuse
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Axel C Carlsson, Docent, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141047
- Sponsor's protocol ID
- 1001
- Status last verified
- May 2020
- First submitted
- 25 Mar 2016
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33084475
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifespan Integration After Sexual Trauma, a Randomized Treatment Study
- ClinicalTrials.gov ID
- NCT03141047
- Acronym / sponsor ID
- 1001
- Keywords
- Sexual trauma, Lifespan Integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Insamlingsstiftelsen Wonsa, World of No Sexual AbuseUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Mar 2016 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifespan Integration | Experimental | Other: Lifespan IntegrationThis 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. |
| Waiting list | No intervention | –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. |
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Sexual trauma 1-5 years before inclusion
- understanding Swedish, read and spoken
Key exclusion criteria (3 listed)
- Psychotic symptoms
- drug abuse
- neuropsychiatric diagnoses ADHD and asperger
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifespan IntegrationA protocol based psychological treatment method | Other | Lifespan Integration |
Primary outcome
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 secondary outcomes
Change of Points of GHQ12
Time frame: 3 weeks
Change of Points of Stressful Events Survey PTSD Short Scale (NSESS)
Time frame: 3 weeks
Self Rated Health and Sickness Questionnaire
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Derived from this study: PubMed 33084475Rajan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel C Carlsson, Docent principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifespan Integration in people with Symptoms of Post Traumatic Stress Disorder (PTSD), run by Insamlingsstiftelsen Wonsa, World of No Sexual Abuse at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Points on Impact of event scale before and after Lifespan Integration treatment after a sexual trauma (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141047, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.