Mental Disorders, Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders
Conditions
Keywords
Psychotherapy
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.
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.
Sponsors
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
* Active psychotic symptoms. * Substance or drug addiction or abuse. * High suicidal risk considered by the individual therapist. * Having participated in the course previously.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire about Process of Recovery' (QPR) Change from baseline | 4 weeks after intervention group has completed group treatment | Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Work and Social Adjustment Scale (WSAS) change from baseline | 4 weeks, 6 months and 12 months after intervention group has completed group treatment | Functional impairment associated with mental Health measured by self-report |
| The International Trauma Questionnaire (ITQ) change from baseline | 4 weeks, 6 months and 12 months after intervention group has completed group treatment | Self-report to capture elements of post-traumatic stress disorder (PTSD) and complex post-traumatic stress disorder (CPTSD) |
| The Clinical Outcome in Routine Evaluation (CORE-10) change from baseline | 4 weeks, 6 months and 12 months after intervention group has completed group treatment | Sel-report measure of psychological distress, capturing general mental health issues. |
| WHO Five Well-Being Index (WHO-5) change from baseline | 4 weeks, 6 months and 12 months after intervention group has completed group treatment | Questionnaire assessing subjective psychological well-being and also a measure of depression. |
| Posttraumatic Cognition Inventory (PTCI-9) change from baseline | 4 weeks, 6 months and 12 months after intervention group has completed group treatment | Self-report measure of negative and dysfunctional posttraumatic cognitions |
Countries
Norway
Contacts
CONTACTKatrine Høyer Holgersen, PhD
CONTACTHeidi Brattland, PhD
STUDY_DIRECTORAnne-Lise Løvaas
St. Olavs Hospital
Outcome results
None listed