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

Not Applicable

Recruiting

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

• Registration Number: NCT03887559
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-21
• Study Start: 2019-03-25
• Study First Posted: 2019-03-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controls	Treatment as usual	Individual treatment as usual only.
Intervention group	Group-based stabilization and skill training in addition to individual treatment	Group-based stabilization and skill-training combined with individual treatment.

Primary Outcome Measures

Name	Time	Method
Questionnaire about Process of Recovery' (QPR) Change from baseline	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

Name	Time	Method
The Clinical Outcome in Routine Evaluation (CORE-10) change from baseline	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.
WHO Five Well-Being Index (WHO-5) change from baseline	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.
The International Trauma Questionnaire (ITQ) change from baseline	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)
The Work and Social Adjustment Scale (WSAS) change from baseline	4 weeks, 6 months and 12 months after intervention group has completed group treatment	Functional impairment associated with mental Health measured by self-report
Posttraumatic Cognition Inventory (PTCI-9) change from baseline	4 weeks, 6 months and 12 months after intervention group has completed group treatment	Self-report measure of negative and dysfunctional posttraumatic cognitions

Trial Locations

Locations (1)

Department of Tiller DPS, St. Olavs Hospital University Hospital in Trondheim; 🇳🇴 Trondheim, Norway