Stress Disorders, Post-Traumatic Clinical Trial
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
NCT number | NCT03887559 |
Other study ID # | 2018/957 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 25, 2019 |
Est. completion date | December 2027 |
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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | December 2027 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Norway | Department of Tiller DPS, St. Olavs Hospital University Hospital in Trondheim | Trondheim |
Lead Sponsor | Collaborator |
---|---|
St. Olavs Hospital | Norwegian University of Science and Technology |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | 12 months after group intervention | |
Other | 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 | |
Other | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | 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) | 4 weeks, 6 months and 12 months after intervention group has completed group treatment | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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