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Enrolling by invitation 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

— Observational PTSD and Trauma-related Symptoms PTSD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psychoterapy.
Who it may be relevant to
Registry conditions: PTSD and Trauma-related Symptoms, PTSD. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Residential Group and Individual Trauma Informed Stabilization Therapy for Adult Survivors of Childhood Trauma

Overview

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.

Interventions

  • Behavioral Psychoterapy
    During 11 weeks admission the programme will include group sessions using different modalities (psychoeducation videos, live psychoeducation groups, expressive arts therapy, equine facilitated therapy, mindfulness and discussion groups) all using TIST methodology. Parallell individual therapy with therapist (psychologist or psychiatrist) and milieu therapist. All therapists will be trained minimum in TIST level 1 and recieve supervision from an expert TIST therapist.

Primary outcome measures

  • Difficulties in emotion regulation scale (DERS) [Time frame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up]
  • Five facet mindfulness questionnaire (FFMQ) [Time frame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up]
  • Self-compassion scale long form (SCS-LF) [Time frame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up]
  • PTSD checklist for DSM-5 (PCL-5) [Time frame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up]
  • International trauma questionnaire (ITQ) [Time frame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up]
Secondary outcome measures (2)
  • Patient health questionnaire 9 (PHQ-9) [Time frame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up]
  • Quality of life [Time frame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Norway · 1 center
  • Modum Bad — Vikersund

Identifiers

NCT: NCT06719167 · TIST pilot project

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗