Post-Traumatic Stress Disorder ComplexEVALINCT06535243
Evaluation of the Efficacy of "Lifespan Integration" (LI) Therapy in Patients With Complex Post-Traumatic Stress Disorder
A study testing Lifespan Integration Therapy (LI) in people with Post-Traumatic Stress Disorder Complex and Psychiatric Disorder, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
The study aims to evaluate the efficacy of a relatively new type of psychotherapy called Lifespan Integration (LI) in patients suffering of complex PTSD Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder Complex, Psychiatric Disorder, Abuse Neglect
- What is being tested?
- Lifespan Integration Therapy (LI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with complex PTSD
- French speaking
- first time following an LI type of therapy
- psychotropic treatment is allowed
Who cannot join
- no other parallel psychotherapy is accepted (if the patient underwent recently any other type of psychotherapy, a "wash out " period of minimum 4 weeks is required )
- no active manic episode at the time of inclusion
- no active psychotic episode at the time of inclusion
- no chronic psychotic disorder diagnosis
- no autistic spectrum disorder diagnosis ,
- no intellectual deficit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU St Anne
Paris, Île-de-France Region, 75014
Alexandru GAMAN, MD, +33658981274, a.gaman@ghu-paris.fr
About this study
Official title: Evaluation of the Efficacy of "Lifespan Integration" Therapy in Patients With Complex Post-Traumatic Stress Disorder
The study aims to evaluate the efficacy of a relatively new type of psychotherapy called Lifespan Integration (LI) in patients suffering of complex PTSD
- Conditions
- Post-Traumatic Stress Disorder Complex, Psychiatric Disorder, Abuse Neglect, Abuse Physical, Abuse, Sexual, Abuse Domestic
- Being tested
- Lifespan Integration Therapy (LI)
- Keywords
- Lifespan Integration Therapy, Psychotrauma type II, Abuse, Victims, Complex Post-traumatic Stress Disorder, Psychotherapy
- Medical subject headings
- Mental Disorders, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifespan Integration Therapy (LI)Behavioural
same as above
| Study group | Role | What they receive |
|---|---|---|
| LI Therapy | Experimental | LI Therapy will be delivered in two recruiting centers by experienced LI Therapy trained psychologists or psychiatrists (a minimum level three of training is required) The intervention will consist in delivering 15 "Basic" Protocol therapy sessions targeting symptoms of complex PTSD The study contains one single arm. One extra-session called PTSD protocol could be optionally delivered if the patient had a very recent trauma that could exacerbate his PTSD symptoms. This session is delivered in the beginning of the research protocol. Receives: Behavioral: Lifespan Integration Therapy (LI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of the scores of International Trauma Questionnaire
International Trauma Questionnaire measures subscores of simple and complex PTSD, the score is calculated using an algorithm, a minimum score of 8 for the PTSD simple part and of 8 for PTSD complex part is needed in order to diagnose a complex PTSD; the maximum score for simple PTSD is 16, same for complex PTSD.
Measured: maximum one year
Secondary outcomes (1)
Difficulties in Emotion Regulation Scale (DERS) Score
the DERS scale (Gratz and Roemer, 2004) contains 36 Likert Scale questions with scores from 1 to 5; the scale can generate a total score and six underscores (assessing nonacceptance, goals, impulse, awareness, strategies, clarity); in a general population cohort the mean score was of 77.99 (SD= 20.72) for N=260 women and 80.66 (SD= 18.79) for N=97 men
Measured: maximum one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress Disorder ComplexStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- eligible candidates to be included in this cohort should be * older than 18 yo * French speaking * with a diagnosis of complex PTSD as confirmed by 1/clinical interview with a trained psychiatrist and 2/ scores for the International Trauma Questionnaire (ITQ), clinical tool based on the ICM 11 criteria
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandru GAMAN, Centre Hospitalier St Anne
- Investigators
- Alexandru GAMAN, MD, Principal investigator, GHU Paris Hôpital St Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535243
- Sponsor's protocol ID
- D21-P019
- Acronym
- EVALI
- Status last verified
- Aug 2024
- First submitted
- 28 Apr 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of "Lifespan Integration" Therapy in Patients With Complex Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT06535243
- Acronym / sponsor ID
- EVALI / D21-P019
- Conditions
- Post-Traumatic Stress Disorder Complex, Psychiatric Disorder, Abuse Neglect, Abuse Physical, Abuse, Sexual, Abuse Domestic
- Keywords
- Lifespan Integration Therapy, Psychotrauma type II, Abuse, Victims, Complex Post-traumatic Stress Disorder, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 2 Aug 2024 (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.
The study aims to evaluate the efficacy of a relatively new type of psychotherapy called Lifespan Integration (LI) in patients suffering of complex PTSD
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- eligible candidates to be included in this cohort should be * older than 18 yo * French speaking * with a diagnosis of complex PTSD as confirmed by 1/clinical interview with a trained psychiatrist and 2/ scores for the International Trauma Questionnaire (ITQ), clinical tool based on the ICM 11 criteria
| Arm | Type | Receives |
|---|---|---|
| LI Therapy | Experimental | Behavioral: Lifespan Integration Therapy (LI)LI Therapy will be delivered in two recruiting centers by experienced LI Therapy trained psychologists or psychiatrists (a minimum level three of training is required) The intervention will consist in delivering 15 "Basic" Protocol therapy sessions targeting symptoms of complex PTSD The study contains one single arm. One extra-session called PTSD protocol could be optionally delivered if the patient had a very recent trauma that could exacerbate his PTSD symptoms. This session is delivered in the beginning of the research protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients diagnosed with complex PTSD
- French speaking
- first time following an LI type of therapy
- psychotropic treatment is allowed
Key exclusion criteria (6 listed)
- no other parallel psychotherapy is accepted (if the patient underwent recently any other type of psychotherapy, a "wash out " period of minimum 4 weeks is required )
- no active manic episode at the time of inclusion
- no active psychotic episode at the time of inclusion
- no chronic psychotic disorder diagnosis
- no autistic spectrum disorder diagnosis ,
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 Integration Therapy (LI)same as above | Behavioural | LI Therapy |
Primary outcome
change of the scores of International Trauma Questionnaire
Time frame: maximum one year
International Trauma Questionnaire measures subscores of simple and complex PTSD, the score is calculated using an algorithm, a minimum score of 8 for the PTSD simple part and of 8 for PTSD complex part is needed in order to diagnose a complex PTSD; the maximum score for simple PTSD is 16, same for complex PTSD.
1 secondary outcome
Difficulties in Emotion Regulation Scale (DERS) Score
Time frame: maximum one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
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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.
Alexandru GAMAN, MD principal investigator
GHU Paris Hôpital St Anne
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 Therapy (LI) in people with Post-Traumatic Stress Disorder Complex and Psychiatric Disorder, run by Centre Hospitalier St Anne at 1 site in France.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Aug 2024. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayat OUATAH (+331 45 65 84 86, hayat.ouatah@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of the scores of International Trauma Questionnaire (time frame: maximum one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2024.