ClinicalTrials.gg
RecruitingNCT06535243EVALIUpdated Aug 2, 2024

Evaluation of the Efficacy of "Lifespan Integration" (LI) Therapy in Patients With Complex Post-Traumatic Stress Disorder

An interventional study of Lifespan Integration Therapy (LI) in Post-Traumatic Stress Disorder Complex, Psychiatric Disorder and Abuse Neglect, sponsored by Centre Hospitalier St Anne. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-02.

Sponsored by Centre Hospitalier St Anne · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 7 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Post-Traumatic Stress Disorder Complex
  • Psychiatric Disorder
  • Abuse Neglect
  • Abuse Physical
  • Abuse, Sexual
  • Abuse Domestic
  • Abuse Verbal

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Keywords

  • Lifespan Integration Therapy
  • Psychotrauma type II
  • Abuse
  • Victims
  • Complex Post-traumatic Stress Disorder
  • Psychotherapy
03

In context

Mental Disorders

1,745 studies on the registry are indexed under Mental Disorders; 353 are open to participants now.

This study's planned enrollment of 38 is below the median of 100 across 1,304 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Centre Hospitalier St Anne is the lead sponsor of 101 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients diagnosed with complex PTSD
  • French speaking
  • first time following an LI type of therapy
  • psychotropic treatment is allowed

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    LI Therapy

    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.

    Behavioral: Lifespan Integration Therapy (LI)

Interventions

  • BehavioralLifespan Integration Therapy (LI)

    same as above

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: maximum one year

Other outcomes

  1. Rosenberg Self - Esteem Scale (RSES) (Rosenberg, 1965)

    RSES is one of the most widely used measures of global self esteem; it contains 10 questions with answers ranging from 0 (poor) to 3 (excellent); five questions are positively worded and five questions are negatively worded. Sinclair and colleagues, 2010 reported a mean score of 22.62 (SD=5.80) in a general population cohort from the US of N=503 individuals

    Time frame: maximum one year

07

Study locations

1 of 1 sites recruiting
  • CHU St Anne
    Paris, Ile De France 75014, France
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Apr 2027, 36 months after the start.

Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 36 months is above that.

Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.

Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2024
First posted
Aug 2, 2024
StartActual
Apr 1, 2024
Primary completionEst.
Apr 1, 2027
CompletionEst.
Apr 1, 2027
Last update
Aug 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06535243
Responsible party
Alexandru GAMAN (Medic Doctor MD, Centre Hospitalier St Anne) — Principal investigator
First posted
Aug 2, 2024
Start date
Apr 1, 2024
Primary completion
Apr 1, 2027 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Aug 2, 2024

Study contacts

Hayat OUATAH
Contact
hayat.ouatah@ghu-paris.fr
+331 45 65 84 86
Naoual KHALFI
Contact
n.khalfi@ghu-paris.fr
+33145658486
Alexandru GAMAN, MD
principal investigator · GHU Paris Hôpital St Anne

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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