Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03887559
• Other study ID #: 2018/957
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: December 2027

Study information

• Verified date: April 2023
• Source: St. Olavs Hospital
• Contact: Katrine Høyer Holgersen, PhD
• Phone: +47 72 82 39 00
• Email: katrine.hoyer.holgersen[@]stolav.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Stress Disorders, Post-Traumatic
• Trauma and Stressor Related Disorders

Intervention

Behavioral:
• Group-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'.

Other:
• Treatment as usual
Treatment as usual: conventional individual treatment (outpatient). Not standardized.

Locations

Country	Name	City	State
Norway	Department of Tiller DPS, St. Olavs Hospital University Hospital in Trondheim	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

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