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

NCT ID: NCT03887559

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-25
• Study Completion Date: 2027-12-31

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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'.

controls

Individual treatment as usual only.

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: OTHER

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

Interventions

Group-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'.

Intervention Type: BEHAVIORAL

Treatment as usual

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

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne-Lise Løvaas

Role: STUDY_DIRECTOR

St. Olavs Hospital

Locations

Department of Tiller DPS, St. Olavs Hospital University Hospital in Trondheim

Trondheim, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Katrine Høyer Holgersen, PhD

Role: CONTACT

katrine.hoyer.holgersen@stolav.no

+47 72 82 39 00

Heidi Brattland, PhD

Role: CONTACT

heidi.brattland@stolav.no

+47 72 82 39 00

Facility Contacts

Katrine Høyer Holgersen, PhD

Role: primary

katrine.hoyer.holgersen@stolav.no

Heidi Brattland, PhD

Role: backup

References

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.

Reference Type: DERIVED

PMID: 32460840 (View on PubMed)

Other Identifiers

2018/957

Identifier Type: -

Identifier Source: org_study_id