Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSt. Olavs Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Active psychotic symptoms.
Substance or drug addiction or abuse.
High suicidal risk considered by the individual therapist.
Having participated in the course previously.
Trial design
Design model
Parallel
Treatments tested in this trial
Group-based stabilization and skill training in addition to individual treatment
BehavioralGroup-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 usual
Other interventionTreatment as usual: conventional individual treatment (outpatient). Not standardized.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: controlsActive comparator 1 intervention
Trial outcomes
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 treatment2
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 treatment3
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 treatmentSecondary 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 treatment2
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 treatment3
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 treatment4
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 treatmentOther 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 intervention2
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 intervention3
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 interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Olavs Hospital
Lead sponsor
Norwegian University of Science and Technology
Collaborator
Source ClinicalTrials.gov