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RecruitingNCT03887559Updated Apr 30, 2026

Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care

An interventional study of Group-based stabilization and skill training in addition to individual treatment and Treatment as usual in Stress Disorders, Post-Traumatic, Mental Disorders and Trauma and Stressor Related Disorders, sponsored by St. Olavs Hospital. Recruiting at 1 site in Norway. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by St. Olavs Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Mar 2019; still recruiting 7 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study evaluates the addition of a group based stabilization and skill-training intervention to individual out-patient treatment for long lasting post-traumatic reactions. Half of the participants will receive the combined treatment while the other half will receive individual treatment as usual.

Read the detailed description

Many patients in mental health care have previously experienced life-stressors and traumatic events that are related to the problems they seek treatment for. Although the diagnostic labels vary, the clinical picture often demonstrates long lasting complex psychological and somatic post-traumatic symptoms such as avoidance, bodily activation, difficulties in regulating emotions and in relationships with others, impaired quality of life and reduced level of function. Patients often receive long-term individual therapy in general mental health care, occasionally without clinically significant improvement. Still, they continue treatment due to high symptom pressure and low level of functioning. The study targets a novel intervention which tests the effect of adding a group based stabilization and skill training intervention to conventional individual treatment among 160 patients already receiving treatment in a community mental health hospital. Change in variables covering mental health issues, functional impairment, well-being, use of hospital services and drug prescriptions will be examined, as well as markers of inflammation found in sera before and after intervention. The purpose is to develop better and more effective treatment options for a large number of patients who receive mental health care in community mental health hospitals.

02

Conditions studied

  • Stress Disorders, Post-Traumatic
  • Mental Disorders
  • Trauma and Stressor Related Disorders

Keywords

  • Psychotherapy
03

In context

Stress Disorders, Post-Traumatic

2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.

This study's planned enrollment of 160 is above the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

St. Olavs Hospital is the lead sponsor of 165 studies on the registry; 30 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Receiving treatment in ordinary out-patient clinics
  • Having been exposed to or witnessing to traumatic event(s) defined as "one or several extremely threatening or horrific events or series of events or situations being of such a character which is likely to overwhelming distress in almost anyone in a similar situation", measured by Stressful Life Events Screening Questionnaire
  • Presenting with posttraumatic reactions such as hyperarousal, avoidance, intrusions, emotional dysregulation or interpersonal difficulties.
  • Symptom duration for a minimum of six months.
  • Understand and speak Norwegian to an extent that is required to participate in a stabilization- and skill-training group.

Exclusion criteria

Exclusion Criteria:

  • Active psychotic symptoms.
  • Substance or drug addiction or abuse.
  • High suicidal risk considered by the individual therapist.
  • Having participated in the course previously.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Group-based stabilization and skill-training combined with individual treatment.

    Behavioral: Group-based stabilization and skill training in addition to individual treatment

  • Active comparator
    controls

    Individual treatment as usual only.

    Other: Treatment as usual

Interventions

  • BehavioralGroup-based stabilization and skill training in addition to individual treatment

    Group-based stabilization and skill training, weekly 2-hour sessions during 20 weeks. Based on the manual "Tilbake til Nåtid" ("Back to here and now") (Holbæk, 2014) developed by clinicians in the highly specialized national trauma clinic 'Modum Bad's Trauma Clinic'.

  • OtherTreatment as usual

    Treatment as usual: conventional individual treatment (outpatient). Not standardized.

06

What researchers measure

Primary outcomes

  1. Questionnaire about Process of Recovery' (QPR) Change from baseline

    Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)

    Time frame: 4 weeks after intervention group has completed group treatment

  2. Questionnaire about Process of Recovery' (QPR) Change from baseline

    Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)

    Time frame: 6 months after intervention group has completed group treatment

  3. Questionnaire about Process of Recovery' (QPR) Change from baseline

    Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)

    Time frame: 12 months after intervention group has completed group treatment

Secondary outcomes

  1. The Work and Social Adjustment Scale (WSAS) change from baseline

    Functional impairment associated with mental Health measured by self-report

    Time frame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment

  2. The International Trauma Questionnaire (ITQ) change from baseline

    Self-report to capture elements of post-traumatic stress disorder (PTSD) and complex post-traumatic stress disorder (CPTSD)

    Time frame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment

  3. The Clinical Outcome in Routine Evaluation (CORE-10) change from baseline

    Sel-report measure of psychological distress, capturing general mental health issues.

    Time frame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment

  4. WHO Five Well-Being Index (WHO-5) change from baseline

    Questionnaire assessing subjective psychological well-being and also a measure of depression.

    Time frame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment

  5. Posttraumatic Cognition Inventory (PTCI-9) change from baseline

    Self-report measure of negative and dysfunctional posttraumatic cognitions

    Time frame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment

Other outcomes

  1. Use of health services in hospitals - Data extracted from The National Patient Register (NPR)- change from baseline

    The National Patient Register (NPR) regularly receives data from all health authorities in Norway on treatment episodes in hospitals and mental health services. Data extracted will include type of clinical unit, time of admission, length of stay in inpatient units, consultations in outpatient units and mobile teams and diagnoses, measured 12 months before group intervention and 12 months after group intervention.

    Time frame: 12 months after group intervention

  2. Prescriptions of medicine -Data extracted from The Norwegian Prescription Database - change from baseline

    The Norwegian Prescription Database regularly receives data on prescriptions on drug prescriptions from doctors in primary and secondary health care services and hospitals. Extracted data will cover prescriptions, 12 months before group intervention and 12 months after group intervention.

    Time frame: 12 months after group intervention

  3. Occupational status- Data extracted from The Norwegian Labour and Welfare Administration (NAV)- change from baseline

    The Norwegian Labour and Welfare Administration (NAV) have data on all citizens working status and sick-leaves lasting for more than two weeks. Extracted data will include information such as sick- and disability leaves 12 months before group intervention and 12 months after group intervention.

    Time frame: 12 months after group intervention

07

Study locations

1 of 1 sites recruiting
  • Department of Tiller DPS, St. Olavs Hospital University Hospital in Trondheim
    Trondheim, Norway
    Recruiting
08

References and documents

Publications

  • Holgersen KH, Bronstad I, Jensen M, Brattland H, Reitan SK, Hassel AM, Arentz M, Lara-Cabrera M, Skjervold AE. A combined individual and group-based stabilization and skill training intervention versus treatment as usual for patients with long lasting posttraumatic reactions receiving outpatient treatment in specialized mental health care - a study protocol for a randomized controlled trial. Trials. 2020 May 27;21(1):432. doi: 10.1186/s13063-020-04297-z. PubMed 32460840 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03887559
Lead sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
Responsible party
Sponsor
First posted
Mar 25, 2019
Start date
Mar 25, 2019
Primary completion
Jun 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Apr 30, 2026

Study contacts

Katrine Høyer Holgersen, PhD
Contact
katrine.hoyer.holgersen@stolav.no
+47 72 82 39 00
Heidi Brattland, PhD
Contact
heidi.brattland@stolav.no
+47 72 82 39 00
Anne-Lise Løvaas
study director · St. Olavs Hospital

Oversight

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

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