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

• Conditions: PTSD and Trauma-related Symptoms; PTSD

• Registration Number: NCT06719167
• Lead Sponsor: Modum Bad

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.

Study Timeline

• Study Start: 2024-10-24
• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-07
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 32

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difficulties in emotion regulation scale (DERS)	Week 0 (Admission), week 11-12 (discharge) and 8 months follow up	Difficulties in emotion regulation scale, scale and subscales
Five facet mindfulness questionnaire (FFMQ)	Week 0 (Admission), week 11-12 (discharge) and 8 months follow up	Five facet mindfulness questionnaire, all subscales
Self-compassion scale long form (SCS-LF)	Week 0 (Admission), week 11-12 (discharge) and 8 months follow up	Self-compassion scale long form, scale and subscales
PTSD checklist for DSM-5 (PCL-5)	Week 0 (Admission), week 11-12 (discharge) and 8 months follow up	PTSD checklist for DSM-5, scale and subscales
International trauma questionnaire (ITQ)	Week 0 (Admission), week 11-12 (discharge) and 8 months follow up	International trauma questionnaire, scale and subscales

Secondary Outcome Measures

Name	Time	Method
Patient health questionnaire 9 (PHQ-9)	Week 0 (Admission), week 11-12 (discharge) and 8 months follow up	Patient health questionnaire 9
Quality of life	Week 0 (Admission), week 11-12 (discharge) and 8 months follow up	Self report on scale of 0-10

Trial Locations

Locations (1)

Modum Bad; 🇳🇴 Vikersund, Buskerud, Norway