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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Disorders; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders
• Intervention / Treatment: Behavioral: Group-based stabilization and skill training in addition to individual treatment; Other: Treatment as usual

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katrine Høyer Holgersen, PhD; Phone Number: +47 72 82 39 00; Email: katrine.hoyer.holgersen@stolav.no
• Study Contact Backup: Name: Heidi Brattland, PhD; Phone Number: +47 72 82 39 00; Email: heidi.brattland@stolav.no

Study Locations

• Norway
  • Trondheim, Norway
    • Recruiting
    • Department of Tiller DPS, St. Olavs Hospital University Hospital in Trondheim
    • Contact: Katrine Høyer Holgersen, PhD; Email: katrine.hoyer.holgersen@stolav.no
    • Contact: Heidi Brattland, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology
• Investigators: Study Director: Anne-Lise Løvaas, St. Olavs Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Psychotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Stress Disorders, Traumatic; Disease; Stress Disorders, Post-Traumatic; Mental Disorders; Trauma and Stressor Related Disorders
• Other Study ID Numbers: 2018/957

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No