Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03887559
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Mental Disorders Trauma and Stressor Related Disorders Behavioral: Group-based stabilization and skill training in addition to individual treatment Other: Treatment as usual Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Group-based stabilization and skill-training combined with individual treatment.
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'.

Active Comparator: controls
Individual treatment as usual only.
Other: Treatment as usual
Treatment as usual: conventional individual treatment (outpatient). Not standardized.




Primary Outcome Measures :
  1. Questionnaire about Process of Recovery' (QPR) Change from baseline [ 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)

  2. Questionnaire about Process of Recovery' (QPR) Change from baseline [ 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)

  3. Questionnaire about Process of Recovery' (QPR) Change from baseline [ 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)


Secondary Outcome Measures :
  1. The Work and Social Adjustment Scale (WSAS) change from baseline [ 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

  2. The International Trauma Questionnaire (ITQ) change from baseline [ 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)

  3. The Clinical Outcome in Routine Evaluation (CORE-10) change from baseline [ 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.

  4. WHO Five Well-Being Index (WHO-5) change from baseline [ 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.

  5. Posttraumatic Cognition Inventory (PTCI-9) change from baseline [ 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


Other Outcome Measures:
  1. Use of health services in hospitals - Data extracted from The National Patient Register (NPR)- change from baseline [ 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.

  2. Prescriptions of medicine -Data extracted from The Norwegian Prescription Database - change from baseline [ 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.

  3. Occupational status- Data extracted from The Norwegian Labour and Welfare Administration (NAV)- change from baseline [ 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887559


Contacts
Layout table for location contacts
Contact: Katrine Høyer Holgersen, PhD +47 72 82 39 00 katrine.hoyer.holgersen@stolav.no
Contact: Heidi Brattland, PhD +47 72 82 39 00 heidi.brattland@stolav.no

Locations
Layout table for location information
Norway
Department of Tiller DPS, St. Olavs Hospital University Hospital in Trondheim Recruiting
Trondheim, Norway
Contact: Katrine Høyer Holgersen, PhD       katrine.hoyer.holgersen@stolav.no   
Contact: Heidi Brattland, PhD         
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
Layout table for investigator information
Study Director: Anne-Lise Løvaas St. Olavs Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03887559    
Other Study ID Numbers: 2018/957
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Psychotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Mental Disorders
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Pathologic Processes
Stress Disorders, Traumatic