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

NCT06535243 | Recruiting DMC

• 1 other identifier: D21-P019
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

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

Outcome Measures

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.

  maximum one year

Secondary Outcomes (1)

• Difficulties in Emotion Regulation Scale (DERS) Score

  maximum one year

Other Outcomes (1)

• Rosenberg Self - Esteem Scale (RSES) (Rosenberg, 1965)

  maximum one year

Study Arms (1)

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.

Behavioral: Lifespan Integration Therapy (LI)

Interventions

Lifespan Integration Therapy (LI) BEHAVIORAL

same as above

LI Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 chronic psychotic disorder diagnosis
• no autistic spectrum disorder diagnosis ,
• no intellectual deficit

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

CHU St Anne

Paris, Île-de-France Region, 75014, France

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Alexandru GAMAN, MD

  GHU Paris Hôpital St Anne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hayat OUATAH

CONTACT

+331 45 65 84 86; hayat.ouatah@ghu-paris.fr

Naoual KHALFI

CONTACT

+33145658486; n.khalfi@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medic Doctor MD

Model Details: 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

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: August 2, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

FR (1)