Clinical trial NCT06719167: A Pilot Research Project on Outcome of Trauma Informed Stabilization Treatment (TIST) for Adults with Complex Trauma Symptoms After Childhood Trauma, At the Department of Trauma Treatment, Modum Bad, Norway
Official title: Residential Group and Individual Trauma Informed Stabilization Therapy for Adult Survivors of Childhood Trauma
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: PTSD and Trauma-related Symptoms
PTSD
Keywords: complex PTSD
childhood trauma
TIST
group treatment
affect regulation
mindfulness
self compassion
Lead sponsor: Modum Bad
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from referrals to the clinic after assessment of eligibilty criteria.

Brief summary: The purpose of the study is to examine the effects of residential group and individual Trauma Informed Stabilization Treatment (TIST) for complex symptoms in adult survivors of childhood trauma in a naturalistic observational study.

Detailed description: Adult survivors of childhood trauma have complex and diverse symptom profiles. The aim of the study is to examine the effects of theTrauma Informed Stabilization Treatment (TIST) model, developed by dr Janina Fisher, in adult survivors of childhood trauma.

32 patients will be recruited from referrals to an residential open door trauma clinic in Norway, Modum Bad. Patients will be admitted for in-patient pre-planned treatment over 11 weeks - consisting of individual therapy and group therapy using different modalities, all within the TIST approach and framework. Patients will be summoned for 6 day follow-up 8 months after treatment.

Eligibility criteria: Inclusion Criteria:

* Adults ≥18 years
* Complex symptom presentations connected to childhood trauma
* All patients will have undergone outpatient therapy with insufficient effect
* Most included patients will have a diagnosis of complex PTSD (diagnosed by M.I.N.I. and clinical evaluation)
* Patients may have diagnosis of unspecified dissociative disorder, personality disorders, depression and other comorbidity.

Exclusion criteria:

* Dissociative identitiy disorder
* Ongoing psychosis
* Ongoing drug addiction
* Very disturbed group function
* Ongoing life crisis
* Mental disability
* Acute suicidality
* Ongoing severe self harm
* Patients with complex dissociative disorders and patients eligible for exposure therapy will be referred to/prioritized for other treatment programmes.

Primary outcomes:
measure: Difficulties in emotion regulation scale (DERS)
timeFrame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up
measure: Five facet mindfulness questionnaire (FFMQ)
timeFrame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up
measure: Self-compassion scale long form (SCS-LF)
timeFrame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up
measure: PTSD checklist for DSM-5 (PCL-5)
timeFrame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up
measure: International trauma questionnaire (ITQ)
timeFrame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up
Secondary outcomes:
measure: Patient health questionnaire 9 (PHQ-9)
timeFrame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up
measure: Quality of life
timeFrame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up
Other outcomes:
Locations:
city: Vikersund
country: Norway
facility: Modum Bad
state: Buskerud
Study officials:
References: