Stress Disorders, Post-TraumaticNCT03887559
Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care
A study testing Group-based stabilization and skill training in addition to individual treatment and Treatment as usual in people with Stress Disorders, Post-Traumatic and Mental Disorders, run by St. Olavs Hospital at 1 site in Norway.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Mental Disorders, Trauma and Stressor Related Disorders
- What is being tested?
- Group-based stabilization and skill training in addition to individual treatment and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNorway
- Study dates
- 25 Mar 2019to Dec 2028
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Active psychotic symptoms.
- Substance or drug addiction or abuse.
- High suicidal risk considered by the individual therapist.
- Having participated in the course previously.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Tiller DPS, St. Olavs Hospital University Hospital in Trondheim
Trondheim
About this study
Official title: Adding a Group Based Stabilization and Skill Training Intervention for Patients With Long Lasting Posttraumatic Reactions Receiving Outpatient Treatment in Specialized Mental Health Care - A Randomized Controlled Trial
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.
- Being tested
- Group-based stabilization and skill training in addition to individual treatment, Treatment as usual
- Keywords
- Psychotherapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Mental Disorders, Trauma and Stressor Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based stabilization and skill training in addition to individual treatmentBehavioural
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'.
Treatment as usualOther
Treatment as usual: conventional individual treatment (outpatient). Not standardized.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Group-based stabilization and skill-training combined with individual treatment. Receives: Behavioral: Group-based stabilization and skill training in addition to individual treatment |
| controls | Active comparator | Individual treatment as usual only. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire about Process of Recovery' (QPR) Change from baseline
Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)
Measured: 4 weeks after intervention group has completed group treatment
Questionnaire about Process of Recovery' (QPR) Change from baseline
Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)
Measured: 6 months after intervention group has completed group treatment
Questionnaire about Process of Recovery' (QPR) Change from baseline
Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)
Measured: 12 months after intervention group has completed group treatment
Secondary outcomes (5)
The Work and Social Adjustment Scale (WSAS) change from baseline
Functional impairment associated with mental Health measured by self-report
Measured: 4 weeks, 6 months and 12 months after intervention group has completed group treatment
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)
Measured: 4 weeks, 6 months and 12 months after intervention group has completed group treatment
The Clinical Outcome in Routine Evaluation (CORE-10) change from baseline
Sel-report measure of psychological distress, capturing general mental health issues.
Measured: 4 weeks, 6 months and 12 months after intervention group has completed group treatment
WHO Five Well-Being Index (WHO-5) change from baseline
Questionnaire assessing subjective psychological well-being and also a measure of depression.
Measured: 4 weeks, 6 months and 12 months after intervention group has completed group treatment
Posttraumatic Cognition Inventory (PTCI-9) change from baseline
Self-report measure of negative and dysfunctional posttraumatic cognitions
Measured: 4 weeks, 6 months and 12 months after intervention group has completed group treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start25 Mar 2019
- Primary completionAug 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Anne-Lise Løvaas, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887559
- Sponsor's protocol ID
- 2018/957
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2019
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding a Group Based Stabilization and Skill Training Intervention for Patients With Long Lasting Posttraumatic Reactions Receiving Outpatient Treatment in Specialized Mental Health Care - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03887559
- Acronym / sponsor ID
- 2018/957
- Keywords
- Psychotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Mar 2019 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Group-based stabilization and skill training in addition to individual treatmentGroup-based stabilization and skill-training combined with individual treatment. |
| controls | Active comparator | Other: Treatment as usualIndividual treatment as usual only. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Active psychotic symptoms.
- Substance or drug addiction or abuse.
- High suicidal risk considered by the individual therapist.
- Having participated in the course previously.
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 |
|---|---|---|
| Group-based stabilization and skill training in addition to individual treatmentGroup-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'. | Behavioural | Intervention group |
| Treatment as usualTreatment as usual: conventional individual treatment (outpatient). Not standardized. | Other | controls |
Primary outcome
Questionnaire about Process of Recovery' (QPR) Change from baseline
Time frame: 4 weeks after intervention group has completed group treatment
Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)
Questionnaire about Process of Recovery' (QPR) Change from baseline
Time frame: 6 months after intervention group has completed group treatment
Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)
Questionnaire about Process of Recovery' (QPR) Change from baseline
Time frame: 12 months after intervention group has completed group treatment
Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)
5 secondary outcomes
The Work and Social Adjustment Scale (WSAS) change from baseline
Time frame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment
The International Trauma Questionnaire (ITQ) change from baseline
Time frame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment
The Clinical Outcome in Routine Evaluation (CORE-10) change from baseline
Time frame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment
WHO Five Well-Being Index (WHO-5) change from baseline
Time frame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment
Posttraumatic Cognition Inventory (PTCI-9) change from baseline
Time frame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment
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 21 Oct 2026.
- Derived from this study: PubMed 32460840Holgersen 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Anne-Lise Løvaas study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based stabilization and skill training in addition to individual treatment and Treatment as usual in people with Stress Disorders, Post-Traumatic and Mental Disorders, run by St. Olavs Hospital 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 4 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. 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?
Questionnaire about Process of Recovery' (QPR) Change from baseline (time frame: 4 weeks after intervention group has completed group treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03887559, which also lists 1 linked publication.
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 21 Oct 2026.