Department of Tiller DPS, St. Olavs Hospital University Hospital in Trondheim
Trondheim, Norway
Location status: Recruiting
NCT Number: NCT03887559
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Trondheim, Norway
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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'.
Treatment as usual: conventional individual treatment (outpatient). Not standardized.
Time frame: 4 weeks after intervention group has completed group treatment
Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)
Time frame: 6 months after intervention group has completed group treatment
Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)
Time frame: 12 months after intervention group has completed group treatment
Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)
Time frame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment
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 treatment
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 treatment
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 treatment
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 treatment
Self-report measure of negative and dysfunctional posttraumatic cognitions
Time frame: 12 months after group intervention
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 intervention
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 intervention
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.
Contact information is provided by the study sponsor or research team.
Heidi Brattland, PhD
CONTACT
Katrine Høyer Holgersen, PhD
CONTACT
St. Olavs Hospital
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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