Clinical trial NCT03887559: Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Mental Disorders
Trauma and Stressor Related Disorders
Keywords: Psychotherapy
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2019-03-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Questionnaire about Process of Recovery' (QPR) Change from baseline
timeFrame: 4 weeks after intervention group has completed group treatment
measure: Questionnaire about Process of Recovery' (QPR) Change from baseline
timeFrame: 6 months after intervention group has completed group treatment
measure: Questionnaire about Process of Recovery' (QPR) Change from baseline
timeFrame: 12 months after intervention group has completed group treatment
Secondary outcomes:
measure: The Work and Social Adjustment Scale (WSAS) change from baseline
timeFrame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment
measure: The International Trauma Questionnaire (ITQ) change from baseline
timeFrame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment
measure: The Clinical Outcome in Routine Evaluation (CORE-10) change from baseline
timeFrame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment
measure: WHO Five Well-Being Index (WHO-5) change from baseline
timeFrame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment
measure: Posttraumatic Cognition Inventory (PTCI-9) change from baseline
timeFrame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment
Other outcomes:
measure: Use of health services in hospitals - Data extracted from The National Patient Register (NPR)- change from baseline
timeFrame: 12 months after group intervention
measure: Prescriptions of medicine -Data extracted from The Norwegian Prescription Database - change from baseline
timeFrame: 12 months after group intervention
measure: Occupational status- Data extracted from The Norwegian Labour and Welfare Administration (NAV)- change from baseline
timeFrame: 12 months after group intervention
Locations:
city: Trondheim
country: Norway
facility: Department of Tiller DPS, St. Olavs Hospital University Hospital in Trondheim
Study officials:
affiliation: St. Olavs Hospital
name: Anne-Lise Løvaas
role: STUDY_DIRECTOR
References:
citation: 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.