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NCT Number: NCT06535243

Evaluation of the Efficacy of "Lifespan Integration" (LI) 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

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Key information

Conditions

Post-Traumatic Stress Disorder Complex Abuse Domestic Abuse Neglect Abuse Physical Abuse Verbal Abuse, Sexual Behavior Coitus Mental Disorders Psychiatric Disorder Sexual Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU St Anne

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

Location status: Recruiting

Location contact

Alexandru GAMAN, MD

CONTACT

[email protected]

+33658981274

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifespan Integration Therapy (LI)

Behavioral

same as above

Primary outcomes

  1. 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.

Secondary outcomes

  1. Difficulties in Emotion Regulation Scale (DERS) Score

    Time frame: maximum one year

    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

Other outcomes

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

    Time frame: maximum one year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Hayat OUATAH

CONTACT

[email protected]

+331 45 65 84 86

Naoual KHALFI

CONTACT

[email protected]

+33145658486

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Registry information

Official study title

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

Acronym: EVALI

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 2, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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