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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Questionnaire about Process of Recovery' (QPR) Change from baseline [Time frame: 4 weeks after intervention group has completed group treatment]
• Questionnaire about Process of Recovery' (QPR) Change from baseline [Time frame: 6 months after intervention group has completed group treatment]
• Questionnaire about Process of Recovery' (QPR) Change from baseline [Time frame: 12 months after intervention group has completed group treatment]

Secondary outcome measures (5)

• 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]
• The International Trauma Questionnaire (ITQ) change from baseline [Time frame: 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 [Time frame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment]
• 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]
• Posttraumatic Cognition Inventory (PTCI-9) change from baseline [Time frame: 4 weeks, 6 months and 12 months after intervention group has completed group treatment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Norway · 1 center

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

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. Trial PMID 32460840

Identifiers

NCT: NCT03887559 · 2018/957

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗