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

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

Study Overview

• Status: Recruiting
• Conditions: Psychiatric Disorder; Post-Traumatic Stress Disorder Complex; Abuse Physical; Abuse Verbal; Abuse Domestic; Abuse Neglect; Abuse, Sexual
• Intervention / Treatment: Behavioral: Lifespan Integration Therapy (LI)

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hayat OUATAH; Phone Number: +331 45 65 84 86; Email: hayat.ouatah@ghu-paris.fr
• Study Contact Backup: Name: Naoual KHALFI; Phone Number: +33145658486; Email: n.khalfi@ghu-paris.fr

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75014
      • Recruiting
      • CHU St Anne
      • Contact: Alexandru GAMAN, MD; Phone Number: +33658981274; Email: a.gaman@ghu-paris.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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); same as above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	maximum one year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	maximum one year

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne
• Investigators: Principal Investigator: Alexandru GAMAN, MD, GHU Paris Hôpital St Anne

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 28, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Psychotherapy; Abuse; Lifespan Integration Therapy; Psychotrauma type II; Victims; Complex Post-traumatic Stress Disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Trauma and Stressor Related Disorders; Problem Behavior; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Mental Disorders
• Other Study ID Numbers: D21-P019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No