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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Group-based stabilization and skill training in addition to individual treatment
Treatment as usual
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Psychotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Tiller DPS, St. Olavs Hospital University Hospital in TrondheimRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

controls

Arm Description

Group-based stabilization and skill-training combined with individual treatment.

Individual treatment as usual only.

Outcomes

Primary Outcome Measures

Questionnaire about Process of Recovery' (QPR) Change from baseline
Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)
Questionnaire about Process of Recovery' (QPR) Change from baseline
Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)
Questionnaire about Process of Recovery' (QPR) Change from baseline
Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)

Secondary Outcome Measures

The Work and Social Adjustment Scale (WSAS) change from baseline
Functional impairment associated with mental Health measured by self-report
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)
The Clinical Outcome in Routine Evaluation (CORE-10) change from baseline
Sel-report measure of psychological distress, capturing general mental health issues.
WHO Five Well-Being Index (WHO-5) change from baseline
Questionnaire assessing subjective psychological well-being and also a measure of depression.
Posttraumatic Cognition Inventory (PTCI-9) change from baseline
Self-report measure of negative and dysfunctional posttraumatic cognitions

Full Information

First Posted
March 11, 2019
Last Updated
April 21, 2023
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03887559
Brief Title
Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Mental Disorders, Trauma and Stressor Related Disorders
Keywords
Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Group-based stabilization and skill-training combined with individual treatment.
Arm Title
controls
Arm Type
Active Comparator
Arm Description
Individual treatment as usual only.
Intervention Type
Behavioral
Intervention Name(s)
Group-based stabilization and skill training in addition to individual treatment
Intervention Description
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'.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Treatment as usual: conventional individual treatment (outpatient). Not standardized.
Primary Outcome Measure Information:
Title
Questionnaire about Process of Recovery' (QPR) Change from baseline
Description
Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)
Time Frame
4 weeks after intervention group has completed group treatment
Title
Questionnaire about Process of Recovery' (QPR) Change from baseline
Description
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
Title
Questionnaire about Process of Recovery' (QPR) Change from baseline
Description
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
Secondary Outcome Measure Information:
Title
The Work and Social Adjustment Scale (WSAS) change from baseline
Description
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
Title
The International Trauma Questionnaire (ITQ) change from baseline
Description
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
Title
The Clinical Outcome in Routine Evaluation (CORE-10) change from baseline
Description
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
Title
WHO Five Well-Being Index (WHO-5) change from baseline
Description
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
Title
Posttraumatic Cognition Inventory (PTCI-9) change from baseline
Description
Self-report measure of negative and dysfunctional posttraumatic cognitions
Time Frame
4 weeks, 6 months and 12 months after intervention group has completed group treatment
Other Pre-specified Outcome Measures:
Title
Use of health services in hospitals - Data extracted from The National Patient Register (NPR)- change from baseline
Description
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
Title
Prescriptions of medicine -Data extracted from The Norwegian Prescription Database - change from baseline
Description
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
Title
Occupational status- Data extracted from The Norwegian Labour and Welfare Administration (NAV)- change from baseline
Description
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.
Time Frame
12 months after group intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katrine Høyer Holgersen, PhD
Phone
+47 72 82 39 00
Email
katrine.hoyer.holgersen@stolav.no
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Brattland, PhD
Phone
+47 72 82 39 00
Email
heidi.brattland@stolav.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Lise Løvaas
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Tiller DPS, St. Olavs Hospital University Hospital in Trondheim
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrine Høyer Holgersen, PhD
Email
katrine.hoyer.holgersen@stolav.no
First Name & Middle Initial & Last Name & Degree
Heidi Brattland, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32460840
Citation
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.
Results Reference
derived

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

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