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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: PTSD; PTSD and Trauma-related Symptoms
• Intervention / Treatment: Behavioral: Psychoterapy

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 Type: Observational
• Enrollment (Estimated): 32

Contacts and Locations

Study Locations

• Norway
  • Buskerud
    • Vikersund, Buskerud, Norway, 3535
      • Modum Bad

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from referrals to the clinic after assessment of eligibilty criteria.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Treatment; All group and individual therapy will be in line with the Trauma Informed Stabilization Treatment (TIST) model, developed by dr Janina Fisher. Patients will be admitted for in-patient pre-planned treatment over 11 weeks in an open door psychiatric hospital. Patients will be summoned for 6 day follow-up 8 months after discharge.

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.; Other Names: TIST; Trauma Informed Stabilization Treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Modum Bad

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: mindfulness; group treatment; childhood trauma; affect regulation; self compassion; complex PTSD; TIST
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: TIST pilot project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No