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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Group-based stabilization and skill-training combined with individual treatment. |
|
| controls | Active Comparator | Individual treatment as usual only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group-based stabilization and skill training in addition to individual treatment | 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'. |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire about Process of Recovery' (QPR) Change from baseline | Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR) | 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) | 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) | 12 months after intervention group has completed group treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The Work and Social Adjustment Scale (WSAS) change from baseline | Functional impairment associated with mental Health measured by self-report | 4 weeks, 6 months and 12 months after intervention group has completed group treatment |
| The International Trauma Questionnaire (ITQ) change from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katrine Høyer Holgersen, PhD | Contact | +47 72 82 39 00 | katrine.hoyer.holgersen@stolav.no | |
| Heidi Brattland, PhD | Contact | +47 72 82 39 00 | heidi.brattland@stolav.no |
| Name | Affiliation | Role |
|---|---|---|
| Anne-Lise Løvaas | St. Olavs Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Tiller DPS, St. Olavs Hospital University Hospital in Trondheim | Recruiting | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32460840 | Derived | 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. |
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|
| Treatment as usual | Other | Treatment as usual: conventional individual treatment (outpatient). Not standardized. |
|
Self-report to capture elements of post-traumatic stress disorder (PTSD) and complex post-traumatic stress disorder (CPTSD) |
| 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. | 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. | 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 | 4 weeks, 6 months and 12 months after intervention group has completed group treatment |
| 12 months after group intervention |
| 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. | 12 months after group intervention |
| 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. | 12 months after group intervention |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D001523 | Mental Disorders |
| D000068099 | Trauma and Stressor Related Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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