PTSD and Trauma-related SymptomsNCT06719167
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 of PTSD and Trauma-related Symptoms and PTSD, run by Modum Bad at 1 site in Norway.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD and Trauma-related Symptoms, PTSD
- What is being tested?
- Psychoterapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 32 participants
- Where
- 1 siteNorway
- Study dates
- 24 Oct 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from referrals to the clinic after assessment of eligibilty criteria.
Who may be able to join
- 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.
Who cannot join
- Dissociative identitiy disorder
- Ongoing psychosis
- Ongoing drug addiction
- Very disturbed group function
- Ongoing life crisis
- Mental disability
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Conditions
- PTSD and Trauma-related Symptoms, PTSD
- Being tested
- Psychoterapy
- Keywords
- complex PTSD, childhood trauma, TIST, group treatment, affect regulation, mindfulness, self compassion
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoterapyBehavioural
Also called TIST, Trauma Informed Stabilization Treatment
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Psychoterapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties in emotion regulation scale (DERS)
Difficulties in emotion regulation scale, scale and subscales
Measured: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up
Five facet mindfulness questionnaire (FFMQ)
Five facet mindfulness questionnaire, all subscales
Measured: 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
Measured: 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
Measured: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up
International trauma questionnaire (ITQ)
International trauma questionnaire, scale and subscales
Measured: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up
Secondary outcomes (2)
Patient health questionnaire 9 (PHQ-9)
Patient health questionnaire 9
Measured: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up
Quality of life
Self report on scale of 0-10
Measured: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start24 Oct 2024
- Primary completionJul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD and Trauma-related SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Modum Bad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719167
- Sponsor's protocol ID
- TIST pilot project
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residential Group and Individual Trauma Informed Stabilization Therapy for Adult Survivors of Childhood Trauma
- ClinicalTrials.gov ID
- NCT06719167
- Acronym / sponsor ID
- TIST pilot project
- Conditions
- PTSD and Trauma-related Symptoms, PTSD
- Keywords
- complex PTSD, childhood trauma, TIST, group treatment, affect regulation, mindfulness, self compassion
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Modum BadUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Behavioral: PsychoterapyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from referrals to the clinic after assessment of eligibilty criteria.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Dissociative identitiy disorder
- Ongoing psychosis
- Ongoing drug addiction
- Very disturbed group function
- Ongoing life crisis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychoterapyAlso: TIST, Trauma Informed Stabilization TreatmentDuring 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. | Behavioural | Treatment |
Primary outcome
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
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
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
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
International trauma questionnaire (ITQ)
Time frame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up
International trauma questionnaire, scale and subscales
2 secondary outcomes
Patient health questionnaire 9 (PHQ-9)
Time frame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up
Quality of life
Time frame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD and Trauma-related Symptoms and PTSD, run by Modum Bad at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties in emotion regulation scale (DERS) (time frame: Week 0 (Admission), week 11-12 (discharge) and 8 months follow up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.