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

St. Olavs Hospital

Status: Enrolling

Conditions: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Post-Traumatic

Treatments: Behavioral: Group-based stabilization and skill training in addition to individual treatment; Other: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT03887559

2018/957

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Behavioral: Group-based stabilization and skill training in addition to individual treatment

controls

Active Comparator group

Description:

Individual treatment as usual only.

Treatment:

Other: Treatment as usual