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Enrolling by invitationNCT06719167Updated Dec 5, 2024

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

An observational study in PTSD and Trauma-related Symptoms and PTSD, sponsored by Modum Bad. Enrolling by invitation at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by Modum Bad · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
32
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • PTSD and Trauma-related Symptoms
  • PTSD

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Keywords

  • complex PTSD
  • childhood trauma
  • TIST
  • group treatment
  • affect regulation
  • mindfulness
  • self compassion
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's planned enrollment of 32 is below the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Modum Bad is the lead sponsor of 18 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
32 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralPsychoterapy

    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

06

What researchers measure

Primary outcomes

  1. Difficulties in emotion regulation scale (DERS)

    Difficulties in emotion regulation scale, scale and subscales

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

  2. Five facet mindfulness questionnaire (FFMQ)

    Five facet mindfulness questionnaire, all subscales

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

  3. Self-compassion scale long form (SCS-LF)

    Self-compassion scale long form, scale and subscales

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

  4. PTSD checklist for DSM-5 (PCL-5)

    PTSD checklist for DSM-5, scale and subscales

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

  5. International trauma questionnaire (ITQ)

    International trauma questionnaire, scale and subscales

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

Secondary outcomes

  1. Patient health questionnaire 9 (PHQ-9)

    Patient health questionnaire 9

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

  2. Quality of life

    Self report on scale of 0-10

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

07

Study locations

1 site
  • Modum Bad
    Vikersund, Buskerud 3535, Norway
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06719167
Lead sponsor
Modum Bad
Responsible party
Sponsor
First posted
Dec 5, 2024
Start date
Oct 24, 2024
Primary completion
Jul 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Dec 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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