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Enrolling by Invitation

NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Modum Bad

Vikersund, Buskerud, 3535, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: TIST, Trauma Informed Stabilization Treatment

Primary outcomes

  1. Difficulties in emotion regulation scale (DERS)

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

    Difficulties in emotion regulation scale, scale and subscales

  2. Five facet mindfulness questionnaire (FFMQ)

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

    Five facet mindfulness questionnaire, all subscales

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

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

    Self-compassion scale long form, scale and subscales

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

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

    PTSD checklist for DSM-5, scale and subscales

  5. International trauma questionnaire (ITQ)

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

    International trauma questionnaire, scale and subscales

Secondary outcomes

  1. Patient health questionnaire 9 (PHQ-9)

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

    Patient health questionnaire 9

  2. Quality of life

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

    Self report on scale of 0-10

Sponsors and collaborators

Lead sponsor

Modum Bad

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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