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

NCT06719167 | Enrolling By Invitation

• 1 other identifier: TIST pilot project
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD and Trauma-related Symptoms; PTSD

Keywords

complex PTSD; childhood trauma; TIST; group treatment; affect regulation; mindfulness; self compassion

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Patient health questionnaire 9 (PHQ-9)

  Week 0 (Admission), week 11-12 (discharge) and 8 months follow up

• Quality of life

  Week 0 (Admission), week 11-12 (discharge) and 8 months follow up

Study Arms (1)

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

Interventions

Psychoterapy BEHAVIORAL

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.

Also known as: TIST, Trauma Informed Stabilization Treatment

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Modum Bad: lead

Study Sites (1)

Modum Bad

Vikersund, Buskerud, 3535, Norway

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 5, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-11

Locations

NO (1)